ClinicalTrials.gov

History of Changes for Study: NCT04843761
ACTIV-3b: Therapeutics for Severely Ill Inpatients With COVID-19 (TESICO)
Latest version (submitted November 7, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 9, 2021 None (earliest Version on record)
2 April 16, 2021 Recruitment Status, Arms and Interventions, Outcome Measures, Contacts/Locations, Study Status and Sponsor/Collaborators
3 April 21, 2021 Study Status and Contacts/Locations
4 April 23, 2021 Contacts/Locations and Study Status
5 April 27, 2021 Contacts/Locations and Study Status
6 April 30, 2021 Contacts/Locations and Study Status
7 May 7, 2021 Contacts/Locations and Study Status
8 May 14, 2021 Contacts/Locations and Study Status
9 May 21, 2021 Contacts/Locations and Study Status
10 May 27, 2021 Contacts/Locations and Study Status
11 June 4, 2021 Study Status and Contacts/Locations
12 June 11, 2021 Contacts/Locations and Study Status
13 June 25, 2021 Contacts/Locations and Study Status
14 July 2, 2021 Contacts/Locations and Study Status
15 July 9, 2021 Contacts/Locations and Study Status
16 July 16, 2021 Contacts/Locations and Study Status
17 July 23, 2021 Contacts/Locations and Study Status
18 August 9, 2021 Study Status, Contacts/Locations and Outcome Measures
19 August 13, 2021 Contacts/Locations and Study Status
20 August 20, 2021 Contacts/Locations and Study Status
21 August 27, 2021 Contacts/Locations and Study Status
22 September 14, 2021 Outcome Measures, Contacts/Locations and Study Status
23 September 24, 2021 Contacts/Locations and Study Status
24 October 1, 2021 Study Status and Contacts/Locations
25 October 18, 2021 Contacts/Locations and Study Status
26 October 22, 2021 Contacts/Locations and Study Status
27 November 2, 2021 Contacts/Locations and Study Status
28 November 8, 2021 Contacts/Locations and Study Status
29 December 10, 2021 Contacts/Locations and Study Status
30 December 17, 2021 Contacts/Locations and Study Status
31 January 14, 2022 Study Status and Contacts/Locations
32 March 11, 2022 Study Status and Contacts/Locations
33 April 14, 2022 Study Status and Contacts/Locations
34 May 13, 2022 Contacts/Locations and Study Status
35 May 31, 2022 Recruitment Status, Contacts/Locations, Study Status and Arms and Interventions
36 August 12, 2022 Study Design, Study Status, Document Section and Contacts/Locations
37 November 7, 2022 Study Status
Comparison Format:

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Changes (Side-by-Side) for Study: NCT04843761
March 11, 2022 (v32) -- April 14, 2022 (v33)

Changes in: Study Status and Contacts/Locations

Open or close this module Study Identification
Unique Protocol ID: 015 / ACTIV-3b 015 / ACTIV-3b
Brief Title: ACTIV-3b: Therapeutics for Severely Ill Inpatients With COVID-19 (TESICO)ACTIV-3b: Therapeutics for Severely Ill Inpatients With COVID-19 (TESICO)
Official Title: A Multicenter, Adaptive, Randomized, Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for Hospitalized Patients With Acute Respiratory Distress Syndrome Associated With COVID-19 A Multicenter, Adaptive, Randomized, Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for Hospitalized Patients With Acute Respiratory Distress Syndrome Associated With COVID-19
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2022 April 2022
Overall Status: RecruitingRecruiting
Study Start: April 20, 2021 April 20, 2021
Primary Completion: October 2022 [Anticipated] October 2022 [Anticipated]
Study Completion: April 2023 [Anticipated] April 2023 [Anticipated]
First Submitted: April 9, 2021 April 9, 2021
First Submitted that
Met QC Criteria:
April 9, 2021 April 9, 2021
First Posted: April 14, 2021 [Actual] April 14, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:
March 11, 2022 April 14, 2022
Last Update Posted: March 15, 2022 [Actual] April 18, 2022 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) National Institute of Allergy and Infectious Diseases (NIAID)
Responsible Party: Sponsor Sponsor
Collaborators: International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)
University of Copenhagen
Medical Research Council
Kirby Institute
Washington D.C. Veterans Affairs Medical Center
AIDS Clinical Trials Group
National Heart, Lung, and Blood Institute (NHLBI)
US Department of Veterans Affairs
Prevention and Early Treatment of Acute Lung Injury (PETAL)
Cardiothoracic Surgical Trials Network (CTSN)
NeuroRx, Inc.
Gilead Sciences
International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)
University of Copenhagen
Medical Research Council
Kirby Institute
Washington D.C. Veterans Affairs Medical Center
AIDS Clinical Trials Group
National Heart, Lung, and Blood Institute (NHLBI)
US Department of Veterans Affairs
Prevention and Early Treatment of Acute Lung Injury (PETAL)
Cardiothoracic Surgical Trials Network (CTSN)
NeuroRx, Inc.
Gilead Sciences
Open or close this module Oversight
U.S. FDA-regulated Drug: YesYes
U.S. FDA-regulated Device: NoNo
Data Monitoring: Yes Yes
Open or close this module Study Description
Brief Summary: This study looks at the safety and effectiveness of different drugs in treating COVID-19 in people who have been hospitalized with the infection and who have acute respiratory failure. Participants in the study will be treated with either a study drug plus current standard of care (SOC), or with placebo plus current SOC. This study looks at the safety and effectiveness of different drugs in treating COVID-19 in people who have been hospitalized with the infection and who have acute respiratory failure. Participants in the study will be treated with either a study drug plus current standard of care (SOC), or with placebo plus current SOC.
Detailed Description:

This is a master protocol to evaluate the safety and efficacy of investigational agents aimed at improving outcomes for patients with acute respiratory failure related to COVID-19.

Trials within this protocol will be adaptive, randomized, blinded and initially placebo-controlled. Participants will receive standard of care (SOC) treatment as part of the protocol. If an investigational agent shows superiority over placebo, SOC for the study of future investigational agents may be modified accordingly.

The international trials within this protocol will be conducted in up to several hundred clinical sites. Participating sites are affiliated with networks funded by the United States National Institutes of Health (NIH) and the US Department of Veterans Affairs.

The protocol is for a phase III platform study that allows investigational drugs to be added and dropped during the course of the study. This allows for efficient testing of new drugs against control within the same trial infrastructure. When more than one agent is being tested concurrently, participants may be randomly allocated across agents (as well as between the agent and its placebo) so the same control group can be shared, when feasible. In some situations, a factorial design may be used to study multiple agents.

Participants will be followed for 90 days following randomization for the primary endpoint and most secondary endpoints. Selected secondary endpoints will be measured at 180 days.

This study is planned to provide 80% power to detect an odds ratio of 1.5 for improvement in recovery status at Day 90 for an investigational agent versus placebo with use of the ordinal outcome. The planned sample size is 640 participants (320 per group) for each investigational agent/placebo. Sample size may be re-estimated before enrollment is complete based on an assessment of whether the pooled proportions of the outcome are still consistent with adequate power for the hypothesized difference measured by the odds ratio.

Randomization will be stratified by study site pharmacy and by receipt of invasive mechanical ventilation, or ECMO at enrollment. Other agent-specific stratification factors may be considered.

Investigational agents suitable for testing in the inpatient setting will be prioritized based on in vitro data, preclinical data, phase I pharmacokinetic and safety data, and clinical data from completed and ongoing trials. In some cases, a vanguard cohort/initial pilot phase may be incorporated into the trial.

An independent Data and Safety Monitoring Board (DSMB) will review interim safety and efficacy data at least monthly. Pre-specified guidelines will be established to recommend early stopping of the trial for evidence of harm or substantial efficacy. The DSMB may recommend discontinuation of an investigational agent if the risks are judged to outweigh the benefits.

This is a master protocol to evaluate the safety and efficacy of investigational agents aimed at improving outcomes for patients with acute respiratory failure related to COVID-19.

Trials within this protocol will be adaptive, randomized, blinded and initially placebo-controlled. Participants will receive standard of care (SOC) treatment as part of the protocol. If an investigational agent shows superiority over placebo, SOC for the study of future investigational agents may be modified accordingly.

The international trials within this protocol will be conducted in up to several hundred clinical sites. Participating sites are affiliated with networks funded by the United States National Institutes of Health (NIH) and the US Department of Veterans Affairs.

The protocol is for a phase III platform study that allows investigational drugs to be added and dropped during the course of the study. This allows for efficient testing of new drugs against control within the same trial infrastructure. When more than one agent is being tested concurrently, participants may be randomly allocated across agents (as well as between the agent and its placebo) so the same control group can be shared, when feasible. In some situations, a factorial design may be used to study multiple agents.

Participants will be followed for 90 days following randomization for the primary endpoint and most secondary endpoints. Selected secondary endpoints will be measured at 180 days.

This study is planned to provide 80% power to detect an odds ratio of 1.5 for improvement in recovery status at Day 90 for an investigational agent versus placebo with use of the ordinal outcome. The planned sample size is 640 participants (320 per group) for each investigational agent/placebo. Sample size may be re-estimated before enrollment is complete based on an assessment of whether the pooled proportions of the outcome are still consistent with adequate power for the hypothesized difference measured by the odds ratio.

Randomization will be stratified by study site pharmacy and by receipt of invasive mechanical ventilation, or ECMO at enrollment. Other agent-specific stratification factors may be considered.

Investigational agents suitable for testing in the inpatient setting will be prioritized based on in vitro data, preclinical data, phase I pharmacokinetic and safety data, and clinical data from completed and ongoing trials. In some cases, a vanguard cohort/initial pilot phase may be incorporated into the trial.

An independent Data and Safety Monitoring Board (DSMB) will review interim safety and efficacy data at least monthly. Pre-specified guidelines will be established to recommend early stopping of the trial for evidence of harm or substantial efficacy. The DSMB may recommend discontinuation of an investigational agent if the risks are judged to outweigh the benefits.

Open or close this module Conditions
Conditions: Covid19 Covid19
Keywords: COVID-19
COVID 19
Coronaviridae Infections
Coronavirus Infections
RNA Virus Infections
Virus Diseases
Nidovirales Infections
SARS-CoV-2
SARS Coronavirus
ACTIV-3
ACTIV3
COVID-19
COVID 19
Coronaviridae Infections
Coronavirus Infections
RNA Virus Infections
Virus Diseases
Nidovirales Infections
SARS-CoV-2
SARS Coronavirus
ACTIV-3
ACTIV3
Open or close this module Study Design
Study Type: InterventionalInterventional
Primary Purpose: TreatmentTreatment
Study Phase: Phase 3Phase 3
Interventional Study Model: Parallel Assignment Parallel Assignment
Number of Arms: 44
Masking: Triple (Participant, Care Provider, Investigator)Triple (Participant, Care Provider, Investigator)
Allocation: RandomizedRandomized
Enrollment: 640 [Anticipated] 640 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Aviptadil + Remdesivir + SOC Biological: Remdesivir
Administered by IV infusion, daily for 10 days. Initial loading dose is 200 mg with all subsequent doses 100 mg.
Biological: Aviptadil
Administered by IV infusion over 12 hours per day for 3 days.
Other Names:
  • Vasoactive Intestinal Peptide
  • VIP
Drug: Corticosteroid
In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.
Placebo Comparator: Aviptadil + Remdesivir Placebo + SOC Drug: Remdesivir Placebo
Commercially available 0.9% sodium chloride solution. Administered by IV infusion daily for 10 days.
Biological: Aviptadil
Administered by IV infusion over 12 hours per day for 3 days.
Other Names:
  • Vasoactive Intestinal Peptide
  • VIP
Drug: Corticosteroid
In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.
Experimental: Aviptadil Placebo + Remdesivir + SOC Biological: Remdesivir
Administered by IV infusion, daily for 10 days. Initial loading dose is 200 mg with all subsequent doses 100 mg.
Drug: Aviptadil Placebo
Commercially available 0.9% sodium chloride solution. Administered by IV infusion over 12 hours per day for 3 days.
Drug: Corticosteroid
In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.
Experimental: Aviptadil Placebo + Remdesivir Placebo + SOC Drug: Remdesivir Placebo
Commercially available 0.9% sodium chloride solution. Administered by IV infusion daily for 10 days.
Drug: Aviptadil Placebo
Commercially available 0.9% sodium chloride solution. Administered by IV infusion over 12 hours per day for 3 days.
Drug: Corticosteroid
In line with NIH treatment guidelines, corticosteroids such as dexamethasone, prednisone, methylprednisolone or hydrocortisone may be administered as SOC.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Recovery, assessed at 90 days
[ Time Frame: Thru Day 90 ]

Recovery categorized as 1 (Best): At home and not receiving new supplemental oxygen for ≥ 77 consecutive days; 2: At home and not receiving new supplemental oxygen for 49-76 consecutive days; 3: At home and not receiving new supplemental oxygen for 1-48 consecutive days; 4: Discharged from hospital but either not yet home or home but receiving new supplemental oxygen; 5: Still hospitalized or receiving hospice care; 6 (Worst): Dead.
Recovery, assessed at 90 days
[ Time Frame: Thru Day 90 ]

Recovery categorized as 1 (Best): At home and not receiving new supplemental oxygen for ≥ 77 consecutive days; 2: At home and not receiving new supplemental oxygen for 49-76 consecutive days; 3: At home and not receiving new supplemental oxygen for 1-48 consecutive days; 4: Discharged from hospital but either not yet home or home but receiving new supplemental oxygen; 5: Still hospitalized or receiving hospice care; 6 (Worst): Dead.
Secondary Outcome Measures:
1. All-cause mortality
[ Time Frame: Thru Day 90 ]

All-cause mortality
[ Time Frame: Thru Day 90 ]

2. Time to death
[ Time Frame: Thru Day 90 ]

Time to death
[ Time Frame: Thru Day 90 ]

3. Composite of time to recovery, days at home off new supplemental oxygen and time to death
[ Time Frame: Thru Day 90 ]

Measured in number of days
Composite of time to recovery, days at home off new supplemental oxygen and time to death
[ Time Frame: Thru Day 90 ]

Measured in number of days
4. Composite of alive, at home and off new supplemental oxygen
[ Time Frame: Thru Day 90 ]

Composite of alive, at home and off new supplemental oxygen
[ Time Frame: Thru Day 90 ]

5. Composite of recovered, alive and not recovered, and dead
[ Time Frame: Thru Day 90 ]

Recovery defined as alive, at home and off new supplemental oxygen
Composite of recovered, alive and not recovered, and dead
[ Time Frame: Thru Day 90 ]

Recovery defined as alive, at home and off new supplemental oxygen
6. Time from randomization to recovery
[ Time Frame: Thru Day 90 ]

Recovery defined as alive, at home and off oxygen (treating death as competing risk)
Time from randomization to recovery
[ Time Frame: Thru Day 90 ]

Recovery defined as alive, at home and off oxygen (treating death as competing risk)
7. Days alive outside short-term acute care hospital
[ Time Frame: Up to Day 90 ]

Using "last off" method.
Days alive outside short-term acute care hospital
[ Time Frame: Up to Day 90 ]

Using "last off" method.
8. Incidence of clinical organ failure or serious infections
[ Time Frame: Thru Day 28 ]

Defined as any one or more of: Worsening respiratory dysfunction; cardiac and vascular dysfunction; renal dysfunction; hepatic dysfunction; neurological dysfunction, haematological dysfunction; serious infection
Incidence of clinical organ failure or serious infections
[ Time Frame: Thru Day 28 ]

Defined as any one or more of: Worsening respiratory dysfunction; cardiac and vascular dysfunction; renal dysfunction; hepatic dysfunction; neurological dysfunction, haematological dysfunction; serious infection
9. Composite of death, clinical organ failure or serious infections
[ Time Frame: Thru Day 90 ]

Composite of death, clinical organ failure or serious infections
[ Time Frame: Thru Day 90 ]

10. Composite of cardiovascular events and thromboembolic events
[ Time Frame: Thru Day 28 ]

Composite of cardiovascular events and thromboembolic events
[ Time Frame: Thru Day 28 ]

11. Composite of cardiovascular events and thromboembolic events
[ Time Frame: Thru Day 90 ]

Composite of cardiovascular events and thromboembolic events
[ Time Frame: Thru Day 90 ]

12. Composite of grade 3 and 4 clinical adverse events, serious adverse events (SAEs) or death
[ Time Frame: Thru Days 5 and 28 ]

Composite of grade 3 and 4 clinical adverse events, serious adverse events (SAEs) or death
[ Time Frame: Thru Days 5 and 28 ]

13. Incidence of infusion reactions
[ Time Frame: Thru Day 180 ]

Incidence of infusion reactions
[ Time Frame: Thru Day 180 ]

14. Percentage of participants for whom infusion was interrupted or stopped prior to completion for any reason
[ Time Frame: Thru Day 90 ]

Percentage of participants for whom infusion was interrupted or stopped prior to completion for any reason
[ Time Frame: Thru Day 90 ]

15. Percentage of participants for whom infusion was interrupted or stopped prior to completion due to adverse event
[ Time Frame: Thru Day 90 ]

Percentage of participants for whom infusion was interrupted or stopped prior to completion due to adverse event
[ Time Frame: Thru Day 90 ]

16. Composite of hospital readmissions or death
[ Time Frame: Thru Day 180 ]

Composite of hospital readmissions or death
[ Time Frame: Thru Day 180 ]

17. Incidence of no home use of supplemental oxygen above pre-morbid oxygen use
[ Time Frame: 14 days ]

Measured as: Alive at home for an uninterrupted 14 day period and no use of continuous supplemental oxygen at end of 14 day time period.
Incidence of no home use of supplemental oxygen above pre-morbid oxygen use
[ Time Frame: 14 days ]

Measured as: Alive at home for an uninterrupted 14 day period and no use of continuous supplemental oxygen at end of 14 day time period.
18. Time to hospital discharge from initial hospitalization
[ Time Frame: Thru Day 180 ]

Time to hospital discharge from initial hospitalization
[ Time Frame: Thru Day 180 ]

19. Composite of death or serious clinical COVID-19 related events
[ Time Frame: Thru Day 90 ]

Composite of death or serious clinical COVID-19 related events
[ Time Frame: Thru Day 90 ]

20. Pulmonary ordinal outcome
[ Time Frame: Days 1-7, 14 and 28 ]

Oxygen requirements measured by 7 categories (1 = least severe, 7 = most severe). The participant's highest (i.e. most severe) observed score is used.
Pulmonary ordinal outcome
[ Time Frame: Days 1-7, 14 and 28 ]

Oxygen requirements measured by 7 categories (1 = least severe, 7 = most severe). The participant's highest (i.e. most severe) observed score is used.
21. Composite of SAEs or death
[ Time Frame: Thru Day 180 ]

Composite of SAEs or death
[ Time Frame: Thru Day 180 ]

22. Incidence of home use of supplemental oxygen above pre-morbid oxygen use
[ Time Frame: Thru Day 180 ]

Measured as: Alive at home and no use of continuous supplemental oxygen for an uninterrupted 14 day period
Incidence of home use of supplemental oxygen above pre-morbid oxygen use
[ Time Frame: Thru Day 180 ]

Measured as: Alive at home and no use of continuous supplemental oxygen for an uninterrupted 14 day period
23. In category 4, 5 or 6 at Day 90 vs. in categories 1-3 at Day 90
[ Time Frame: Day 90 ]

Categories are 1 (Best): At home an off oxygen for ≥ 77 consecutive days; 2: At home and off oxygen for 49-76 consecutive days; 3: At home and off oxygen for 1-48 consecutive days; 4: Not hospitalized and either at home on oxygen or not at home; 5: Hospitalized for medical care or in hospice care; 6 (Worst): Dead.
In category 4, 5 or 6 at Day 90 vs. in categories 1-3 at Day 90
[ Time Frame: Day 90 ]

Categories are 1 (Best): At home an off oxygen for ≥ 77 consecutive days; 2: At home and off oxygen for 49-76 consecutive days; 3: At home and off oxygen for 1-48 consecutive days; 4: Not hospitalized and either at home on oxygen or not at home; 5: Hospitalized for medical care or in hospice care; 6 (Worst): Dead.
24. In category 5 or 6 at Day 90 vs. in categories 1-4 at Day 90
[ Time Frame: Day 90 ]

Categories are 1 (Best): At home an off oxygen for ≥ 77 consecutive days; 2: At home and off oxygen for 49-76 consecutive days; 3: At home and off oxygen for 1-48 consecutive days; 4: Not hospitalized and either at home on oxygen or not at home; 5: Hospitalized for medical care or in hospice care; 6 (Worst): Dead.
In category 5 or 6 at Day 90 vs. in categories 1-4 at Day 90
[ Time Frame: Day 90 ]

Categories are 1 (Best): At home an off oxygen for ≥ 77 consecutive days; 2: At home and off oxygen for 49-76 consecutive days; 3: At home and off oxygen for 1-48 consecutive days; 4: Not hospitalized and either at home on oxygen or not at home; 5: Hospitalized for medical care or in hospice care; 6 (Worst): Dead.
Open or close this module Eligibility
Minimum Age: 18 Years 18 Years
Maximum Age:
Sex: All All
Gender Based:
Accepts Healthy Volunteers: NoNo
Criteria:

Inclusion Criteria:

  • Signed informed consent.
  • Requiring admission to hospital for acute medical care (not for purely public health or quarantine purposes).
  • Current respiratory failure (i.e. receipt of high-flow nasal cannula, non-invasive ventilation, invasive mechanical ventilation, or ECMO (extracorporeal membrane oxygenation) used to treat acute hypoxemic respiratory failure).
  • SARS-CoV-2 (COVID-19) infection, documented by a nucleic acid test (NAT) or equivalent testing with most recent rest within 14 days prior to randomization.
  • Respiratory failure is believed to be due to SARS-CoV-2 pneumonia.

Exclusion Criteria:

  • Known allergy to investigational agent or vehicle.
  • More than 4 days since initiation of support for respiratory failure.
  • Chronic/home mechanical ventilation (invasive or non-invasive) for chronic lung or neuromuscular disease (non-invasive ventilation used solely for sleep-disordered breathing is not an exclusion).
  • Moribund patient (i.e. not expected to survive 24 hours).
  • Active use of "comfort care" or other hospice-equivalent standard of care.
  • Expected inability to participate in study procedures.
  • In the opinion of the investigator, any condition for which, participation would not be in the best interest of the participant or that could limit protocol-specified assessments.
  • Previous enrollment in TESICO

Agent-specific exclusion criteria

  • Prior receipt of any dose of remdesivir during present illness (remdesivir agent).
  • GFR (glomerular filtration rate) < 30 ml/min and not receiving dialysis (remdesivir agent).
  • ALT (alanine aminotransferase) or AST (aspartate aminotransferase) > 10 times upper limit of normal (remdesivir agent).
  • Unwillingness to commit to avoid sex that may result in pregnancy for at least 7 days after completion of remdesivir vs. placebo (remdesivir agent).
  • Refractory hypotension (aviptadil agent).
  • Severe diarrhea (Aviptadil agent).
  • Current C. difficile infection (aviptadil agent).
  • Pregnancy or current breast-feeding (aviptadil agent).
  • End-stage liver disease (aviptadil agent).

Inclusion Criteria:

  • Signed informed consent.
  • Requiring admission to hospital for acute medical care (not for purely public health or quarantine purposes).
  • Current respiratory failure (i.e. receipt of high-flow nasal cannula, non-invasive ventilation, invasive mechanical ventilation, or ECMO (extracorporeal membrane oxygenation) used to treat acute hypoxemic respiratory failure).
  • SARS-CoV-2 (COVID-19) infection, documented by a nucleic acid test (NAT) or equivalent testing with most recent rest within 14 days prior to randomization.
  • Respiratory failure is believed to be due to SARS-CoV-2 pneumonia.

Exclusion Criteria:

  • Known allergy to investigational agent or vehicle.
  • More than 4 days since initiation of support for respiratory failure.
  • Chronic/home mechanical ventilation (invasive or non-invasive) for chronic lung or neuromuscular disease (non-invasive ventilation used solely for sleep-disordered breathing is not an exclusion).
  • Moribund patient (i.e. not expected to survive 24 hours).
  • Active use of "comfort care" or other hospice-equivalent standard of care.
  • Expected inability to participate in study procedures.
  • In the opinion of the investigator, any condition for which, participation would not be in the best interest of the participant or that could limit protocol-specified assessments.
  • Previous enrollment in TESICO

Agent-specific exclusion criteria

  • Prior receipt of any dose of remdesivir during present illness (remdesivir agent).
  • GFR (glomerular filtration rate) < 30 ml/min and not receiving dialysis (remdesivir agent).
  • ALT (alanine aminotransferase) or AST (aspartate aminotransferase) > 10 times upper limit of normal (remdesivir agent).
  • Unwillingness to commit to avoid sex that may result in pregnancy for at least 7 days after completion of remdesivir vs. placebo (remdesivir agent).
  • Refractory hypotension (aviptadil agent).
  • Severe diarrhea (Aviptadil agent).
  • Current C. difficile infection (aviptadil agent).
  • Pregnancy or current breast-feeding (aviptadil agent).
  • End-stage liver disease (aviptadil agent).
Open or close this module Contacts/Locations
Central Contact Person: If interested in participating in this study, please contact the appropriate site or
Telephone: send email to
Email: tesico@insight-trials.org
If interested in participating in this study, please contact the appropriate site or
Telephone: send email to
Email: tesico@insight-trials.org
Central Contact Backup: Do not include personal information in email. Type ACTIV-3b in subject line.Do not include personal information in email. Type ACTIV-3b in subject line.
Study Officials: Samuel Brown, MD
Principal Investigator
Intermountain Medical Center/University of Utah
Samuel Brown, MD
Principal Investigator
Intermountain Medical Center/University of Utah
Prof. James Neaton
Study Chair
INSIGHT Statistical and Coordinating Centre, University of Minnesota
Prof. James Neaton
Study Chair
INSIGHT Statistical and Coordinating Centre, University of Minnesota
Locations: United States, ArizonaUnited States, Arizona
Banner University Medical Center Tucson (Site 206-004), 1625 N. Campbell Avenue
[Recruiting]
Tucson, Arizona, United States, 85719
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicopetal@insight-trials.org
Contact:Contact: Do not include personal information in email
Banner University Medical Center Tucson (Site 206-004), 1625 N. Campbell Avenue
[Recruiting]
Tucson, Arizona, United States, 85719
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicopetal@insight-trials.org
Contact:Contact: Do not include personal information in email
United States, CaliforniaUnited States, California
UCSF Fresno (Site 203-005), 155 N. Fresno Street
[Recruiting]
Fresno, California, United States, 93701
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicopetal@insight-trials.org
Contact:Contact: Do not include personal information in email
UCSF Fresno (Site 203-005), 155 N. Fresno Street
[Recruiting]
Fresno, California, United States, 93701
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicopetal@insight-trials.org
Contact:Contact: Do not include personal information in email
VA Loma Linda Healthcare System (Site 074-017), 11201 Benton Street
[Recruiting]
Loma Linda, California, United States, 92357
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicova@insight-trials.org
Contact:Contact: Do not include personal information in email
VA Loma Linda Healthcare System (Site 074-017), 11201 Benton Street
[Recruiting]
Loma Linda, California, United States, 92357
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicova@insight-trials.org
Contact:Contact: Do not include personal information in email
Cedars-Sinai Medical Center (Site 208-002), 8700 Beverly Boulevard
[Recruiting]
Los Angeles, California, United States, 90048
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicopetal@insight-trials.org
Contact:Contact: Do not include personal information in email
Cedars-Sinai Medical Center (Site 208-002), 8700 Beverly Boulevard
[Recruiting]
Los Angeles, California, United States, 90048
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicopetal@insight-trials.org
Contact:Contact: Do not include personal information in email
West Los Angeles VA Medical Center (Site 074-001), 11301 Wilshire Blvd.
[Not yet recruiting]
Los Angeles, California, United States, 90073
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicova@insight-trials.org
Contact:Contact: Do not include personal information in email
West Los Angeles VA Medical Center (Site 074-001), 11301 Wilshire Blvd.
[Not yet recruiting]
Los Angeles, California, United States, 90073
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicova@insight-trials.org
Contact:Contact: Do not include personal information in email
Ronald Reagan UCLA Medical Center (Site 203-002), 757 Westwood Plaza
[Recruiting]
Los Angeles, California, United States, 90095
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicopetal@insight-trials.org
Contact:Contact: Do not include personal information in email
Ronald Reagan UCLA Medical Center (Site 203-002), 757 Westwood Plaza
[Recruiting]
Los Angeles, California, United States, 90095
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicopetal@insight-trials.org
Contact:Contact: Do not include personal information in email
UCSF Medical Center at Mount Zion (Site 203-007), 1600 Divisadero St.
[Recruiting]
San Francisco, California, United States, 94115
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicopetal@insight-trials.org
Contact:Contact: Do not include personal information in email
UCSF Medical Center at Mount Zion (Site 203-007), 1600 Divisadero St.
[Recruiting]
San Francisco, California, United States, 94115
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicopetal@insight-trials.org
Contact:Contact: Do not include personal information in email
UCSF Medical Center (Site 203-001), Moffit-Long Hospital, 505 Parnassus Ave.
[Recruiting]
San Francisco, California, United States, 94143
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicopetal@insight-trials.org
Contact:Contact: Do not include personal information in email
UCSF Medical Center (Site 203-001), Moffit-Long Hospital, 505 Parnassus Ave.
[Recruiting]
San Francisco, California, United States, 94143
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicopetal@insight-trials.org
Contact:Contact: Do not include personal information in email
Stanford University Hospital & Clinics (Site 203-003), 300 Pasteur Dr.
[Recruiting]
Stanford, California, United States, 94305
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicopetal@insight-trials.org
Contact:Contact: Do not include personal information in email
Stanford University Hospital & Clinics (Site 203-003), 300 Pasteur Dr.
[Recruiting]
Stanford, California, United States, 94305
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicopetal@insight-trials.org
Contact:Contact: Do not include personal information in email
United States, ColoradoUnited States, Colorado
University of Colorado Hospital (Site 204-001), 12605 E. 16th Avenue
[Recruiting]
Aurora, Colorado, United States, 80045
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicopetal@insight-trials.org
Contact:Contact: Do not include personal information in email
University of Colorado Hospital (Site 204-001), 12605 E. 16th Avenue
[Recruiting]
Aurora, Colorado, United States, 80045
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicopetal@insight-trials.org
Contact:Contact: Do not include personal information in email
Denver Health Medical Center (Site 204-004), 780 Delaware Street, Pavilion B
[Recruiting]
Denver, Colorado, United States, 80204
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicopetal@insight-trials.org
Contact:Contact: Do not include personal information in email
Denver Health Medical Center (Site 204-004), 780 Delaware Street, Pavilion B
[Recruiting]
Denver, Colorado, United States, 80204
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicopetal@insight-trials.org
Contact:Contact: Do not include personal information in email
United States, District of ColumbiaUnited States, District of Columbia
MedStar Health Research Institute (Site 009-021), 110 Irving St., NW.
[Recruiting]
Washington, District of Columbia, United States, 20010
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicowdc@insight-trials.org
Contact:Contact: Do not include personal information in email
MedStar Health Research Institute (Site 009-021), 110 Irving St., NW.
[Recruiting]
Washington, District of Columbia, United States, 20010
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicowdc@insight-trials.org
Contact:Contact: Do not include personal information in email
Washington DC VA Medical Center (Site 009-004), 50 Irving Street, NW.
[Recruiting]
Washington, District of Columbia, United States, 20422
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicowdc@insight-trials.org
Contact:Contact: Do not include personal information in email
Washington DC VA Medical Center (Site 009-004), 50 Irving Street, NW.
[Recruiting]
Washington, District of Columbia, United States, 20422
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicowdc@insight-trials.org
Contact:Contact: Do not include personal information in email
United States, GeorgiaUnited States, Georgia
Emory University (Site 301-008), Bldg. A, Suite 2236, 1365 Clifton Rd., NE.
[Recruiting]
Atlanta, Georgia, United States, 30322
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicoctsn@insight-trials.org
Contact:Contact: Do not include personal information in email
Emory University (Site 301-008), Bldg. A, Suite 2236, 1365 Clifton Rd., NE.
[Recruiting]
Atlanta, Georgia, United States, 30322
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicoctsn@insight-trials.org
Contact:Contact: Do not include personal information in email
United States, IllinoisUnited States, Illinois
Edward Hines VA Hospital (Site 074-012), 5000 S. 5th Ave.
[Not yet recruiting]
Hines, Illinois, United States, 60141
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicova@insight-trials.org
Contact:Contact: Do not include personal information in email
Edward Hines VA Hospital (Site 074-012), 5000 S. 5th Ave.
[Not yet recruiting]
Hines, Illinois, United States, 60141
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicova@insight-trials.org
Contact:Contact: Do not include personal information in email
United States, MassachusettsUnited States, Massachusetts
Massachusetts General Hospital (Site 202-002), 55 Fruit Street
[Recruiting]
Boston, Massachusetts, United States, 02114
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicopetal@insight-trials.org
Contact:Contact: Do not include personal information in email
Massachusetts General Hospital (Site 202-002), 55 Fruit Street
[Recruiting]
Boston, Massachusetts, United States, 02114
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicopetal@insight-trials.org
Contact:Contact: Do not include personal information in email
Baystate Medical Center (Site 201-001), Critical Care Research, 759 Chestnut Street
[Recruiting]
Springfield, Massachusetts, United States, 01199
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicopetal@insight-trials.org
Contact:Contact: Do not include personal information in email
Baystate Medical Center (Site 201-001), Critical Care Research, 759 Chestnut Street
[Recruiting]
Springfield, Massachusetts, United States, 01199
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicopetal@insight-trials.org
Contact:Contact: Do not include personal information in email
United States, MichiganUnited States, Michigan
Henry Ford Health System (Site 205-006), 2799 W. Grand Blvd.
[Not yet recruiting]
Detroit, Michigan, United States, 48202
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicopetal@insight-trials.org
Contact:Contact: Do not include personal information in email
Henry Ford Health System (Site 205-006), 2799 W. Grand Blvd.
[Not yet recruiting]
Detroit, Michigan, United States, 48202
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicopetal@insight-trials.org
Contact:Contact: Do not include personal information in email
United States, New YorkUnited States, New York
Montefiore Medical Center - Moses campus (Site 206-003), 111 E. 210th Street
[Recruiting]
Bronx, New York, United States, 10467
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicopetal@insight-trials.org
Contact:Contact: Do not include personal information in email
Montefiore Medical Center - Moses campus (Site 206-003), 111 E. 210th Street
[Recruiting]
Bronx, New York, United States, 10467
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicopetal@insight-trials.org
Contact:Contact: Do not include personal information in email
Montefiore Medical Center - Moses Hospital (Site 206-001), 111 E. 210th Street
[Recruiting]
Bronx, New York, United States, 10467
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicopetal@insight-trials.org
Contact:Contact: Do not include personal information in email
Montefiore Medical Center - Moses Hospital (Site 206-001), 111 E. 210th Street
[Recruiting]
Bronx, New York, United States, 10467
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicopetal@insight-trials.org
Contact:Contact: Do not include personal information in email
Mount Sinai Medical Center (Site 301-012), Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place
[Recruiting]
New York, New York, United States, 10029
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicoctsn@insight-trials.org
Contact:Contact: Do not include personal information in email
Mount Sinai Medical Center (Site 301-012), Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place
[Recruiting]
New York, New York, United States, 10029
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicoctsn@insight-trials.org
Contact:Contact: Do not include personal information in email
Columbia University Irving Medical Center (Site 301-027), 177 Fort Washington Ave.
[Recruiting]
New York, New York, United States, 10032
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicoctsn@insight-trials.org
Contact:Contact: Do not include personal information in email
Columbia University Irving Medical Center (Site 301-027), 177 Fort Washington Ave.
[Recruiting]
New York, New York, United States, 10032
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicoctsn@insight-trials.org
Contact:Contact: Do not include personal information in email
United States, North CarolinaUnited States, North Carolina
Duke University Hospital (Site 301-006), 2301 Erwin Road
[Recruiting]
Durham, North Carolina, United States, 27710
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicoctsn@insight-trials.org
Contact:Contact: Do not include personal information in email
Duke University Hospital (Site 301-006), 2301 Erwin Road
[Recruiting]
Durham, North Carolina, United States, 27710
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicoctsn@insight-trials.org
Contact:Contact: Do not include personal information in email
Wake Forest Baptist Health (Site 210-001), Medical Center Blvd
[Recruiting]
Winston-Salem, North Carolina, United States, 27157
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicopetal@insight-trials.org
Contact:Contact: Do not include personal information in email
Wake Forest Baptist Health (Site 210-001), Medical Center Blvd
[Recruiting]
Winston-Salem, North Carolina, United States, 27157
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicopetal@insight-trials.org
Contact:Contact: Do not include personal information in email
United States, OhioUnited States, Ohio
University of Cincinnati Medical Center (Site 207-003), 234 Goodman Street, ML 0740
[Recruiting]
Cincinnati, Ohio, United States, 45219
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicopetal@insight-trials.org
Contact:Contact: Do not include personal information in email
University of Cincinnati Medical Center (Site 207-003), 234 Goodman Street, ML 0740
[Recruiting]
Cincinnati, Ohio, United States, 45219
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicopetal@insight-trials.org
Contact:Contact: Do not include personal information in email
Cleveland Clinic Fairview Hosptial (Site 207-005), 18101 Lorain Ave.
[Recruiting]
Cleveland, Ohio, United States, 44111
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicopetal@insight-trials.org
Contact:Contact: Do not include personal information in email
Cleveland Clinic Fairview Hosptial (Site 207-005), 18101 Lorain Ave.
[Recruiting]
Cleveland, Ohio, United States, 44111
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicopetal@insight-trials.org
Contact:Contact: Do not include personal information in email
Cleveland Clinic Foundation (Site 207-001), 9500 Euclid Ave.
[Recruiting]
Cleveland, Ohio, United States, 44195
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicopetal@insight-trials.org
Contact:Contact: Do not include personal information in email
Cleveland Clinic Foundation (Site 207-001), 9500 Euclid Ave.
[Recruiting]
Cleveland, Ohio, United States, 44195
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicopetal@insight-trials.org
Contact:Contact: Do not include personal information in email
The Ohio State University Wexner Medical Center (Site 207-004), 410 W. 10th Avenue
[Recruiting]
Columbus, Ohio, United States, 43210
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicopetal@insight-trials.org
Contact:Contact: Do not include personal information in email
The Ohio State University Wexner Medical Center (Site 207-004), 410 W. 10th Avenue
[Recruiting]
Columbus, Ohio, United States, 43210
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicopetal@insight-trials.org
Contact:Contact: Do not include personal information in email
Cleveland Clinic Marymount Campus (Site 207-006), 12300 McCracken Road
[Recruiting]
Garfield Heights, Ohio, United States, 44125
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicopetal@insight-trials.org
Contact:Contact: Do not include personal information in email
Cleveland Clinic Marymount Campus (Site 207-006), 12300 McCracken Road
[Recruiting]
Garfield Heights, Ohio, United States, 44125
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicopetal@insight-trials.org
Contact:Contact: Do not include personal information in email
Cleveland Clinic Hillcrest Hospital (Site 207-007), 6780 Mayfield Road
[Recruiting]
Mayfield Heights, Ohio, United States, 44124
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicopetal@insight-trials.org
Contact:Contact: Do not include personal information in email
Cleveland Clinic Hillcrest Hospital (Site 207-007), 6780 Mayfield Road
[Recruiting]
Mayfield Heights, Ohio, United States, 44124
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicopetal@insight-trials.org
Contact:Contact: Do not include personal information in email
United States, OregonUnited States, Oregon
Oregon Health & Science University (Site 208-003), 3181 SW Sam Jackson Park Rd.
[Recruiting]
Portland, Oregon, United States, 97239-3098
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicopetal@insight-trials.org
Contact:Contact: Do not include personal information in email
Oregon Health & Science University (Site 208-003), 3181 SW Sam Jackson Park Rd.
[Recruiting]
Portland, Oregon, United States, 97239-3098
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicopetal@insight-trials.org
Contact:Contact: Do not include personal information in email
United States, South CarolinaUnited States, South Carolina
Medical University of South Carolina (Site 210-002), 96 Jonathan Lucas St., CSB 214
[Recruiting]
Charleston, South Carolina, United States, 29425
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicopetal@insight-trials.org
Contact:Contact: Do not include personal information in email
Medical University of South Carolina (Site 210-002), 96 Jonathan Lucas St., CSB 214
[Recruiting]
Charleston, South Carolina, United States, 29425
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicopetal@insight-trials.org
Contact:Contact: Do not include personal information in email
United States, TennesseeUnited States, Tennessee
Vanderbilt University Medical Center (Site 212-001), 1211 Medical Center Drive
[Recruiting]
Nashville, Tennessee, United States, 37232
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicopetal@insight-trials.org
Contact:Contact: Do not include personal information in email
Vanderbilt University Medical Center (Site 212-001), 1211 Medical Center Drive
[Recruiting]
Nashville, Tennessee, United States, 37232
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicopetal@insight-trials.org
Contact:Contact: Do not include personal information in email
United States, TexasUnited States, Texas
Baylor, Scott and White Health (Site 301-003), Baylor University Medical Center, 3500 Gaston Ave.
[Recruiting]
Dallas, Texas, United States, 75246
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to ticoctsn@insight-trials.org
Contact:Contact: Do not include personal information in email
Baylor, Scott and White Health (Site 301-003), Baylor University Medical Center, 3500 Gaston Ave.
[Recruiting]
Dallas, Texas, United States, 75246
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to ticoctsn@insight-trials.org
Contact:Contact: Do not include personal information in email
Houston Methodist Hospital (Site 301-028), 6565 Fannin Street
[Recruiting]
Houston, Texas, United States, 77030
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicoctsn@insight-trials.org
Contact:Contact: Do not include personal information in email
Houston Methodist Hospital (Site 301-028), 6565 Fannin Street
[Recruiting]
Houston, Texas, United States, 77030
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicoctsn@insight-trials.org
Contact:Contact: Do not include personal information in email
Texas Heart Institute (Site 301-017), 6770 Bertner, MC4-266
[Recruiting]
Houston, Texas, United States, 77030
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicoctsn@insight-trials.org
Contact:Contact: Do not include personal information in email
Texas Heart Institute (Site 301-017), 6770 Bertner, MC4-266
[Recruiting]
Houston, Texas, United States, 77030
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicoctsn@insight-trials.org
Contact:Contact: Do not include personal information in email
University of Texas Health Science Center (Site 203-006), 7000 Fannin St.
[Recruiting]
Houston, Texas, United States, 77030
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicopetal@insight-trials.org
Contact:Contact: Do not include personal information in email
University of Texas Health Science Center (Site 203-006), 7000 Fannin St.
[Recruiting]
Houston, Texas, United States, 77030
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicopetal@insight-trials.org
Contact:Contact: Do not include personal information in email
United States, UtahUnited States, Utah
Intermountain Medical Center (Site 211-001), 5121 South Cottonwood Street
[Recruiting]
Murray, Utah, United States, 84107
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicopetal@insight-trials.org
Contact:Contact: Do not include personal information in email
Intermountain Medical Center (Site 211-001), 5121 South Cottonwood Street
[Recruiting]
Murray, Utah, United States, 84107
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicopetal@insight-trials.org
Contact:Contact: Do not include personal information in email
University of Utah Hospital (Site 211-002), 50 North Medical Drive
[Recruiting]
Salt Lake City, Utah, United States, 84132
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicopetal@insight-trials.org
Contact:Contact: Do not include personal information in email
University of Utah Hospital (Site 211-002), 50 North Medical Drive
[Recruiting]
Salt Lake City, Utah, United States, 84132
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicopetal@insight-trials.org
Contact:Contact: Do not include personal information in email
United States, VirginiaUnited States, Virginia
UVA School of Medicine (Site 210-003), University of Virginia Health System, University Hospital, 1215 Lee St.
[Recruiting]
Charlottesville, Virginia, United States, 22908
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicopetal@insight-trials.org
Contact:Contact: Do not include personal information in email
UVA School of Medicine (Site 210-003), University of Virginia Health System, University Hospital, 1215 Lee St.
[Recruiting]
Charlottesville, Virginia, United States, 22908
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicopetal@insight-trials.org
Contact:Contact: Do not include personal information in email
United States, WashingtonUnited States, Washington
Harborview Medical Center (Site 208-001), 325 9th Ave.
[Recruiting]
Seattle, Washington, United States, 98104
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicopetal@insight-trials.org
Contact:Contact: Do not include personal information in email
Harborview Medical Center (Site 208-001), 325 9th Ave.
[Recruiting]
Seattle, Washington, United States, 98104
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicopetal@insight-trials.org
Contact:Contact: Do not include personal information in email
Swedish Medical Center (Site 208-005), 747 Broadway
[Recruiting]
Seattle, Washington, United States, 98122
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicopetal@insight-trials.org
Contact:Contact: Do not include personal information in email
Swedish Medical Center (Site 208-005), 747 Broadway
[Recruiting]
Seattle, Washington, United States, 98122
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicopetal@insight-trials.org
Contact:Contact: Do not include personal information in email
United States, West VirginiaUnited States, West Virginia
West Virginia University (Site 301-023), One Medical Center Drive
[Recruiting]
Morgantown, West Virginia, United States, 26506
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicoctsn@insight-trials.org
Contact:Contact: Do not include personal information in email
West Virginia University (Site 301-023), One Medical Center Drive
[Recruiting]
Morgantown, West Virginia, United States, 26506
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicoctsn@insight-trials.org
Contact:Contact: Do not include personal information in email
Brazil
Naval Hospital Marcílio Dias (Site 649-213), Rua Cesar Zama, 185 - Lins de Vasconcelos
[Not yet recruiting]
Rio De Janeiro, Brazil, 20725090
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicowdc@insight-trials.org
Contact:Contact: Do not include personal information in email
Real e Benemerita Associação Portuguesa de Beneficencia/SP (Site 649-201), R. Maestro Cardim, 769 - Bela Vista
[Not yet recruiting]
São Paulo, Brazil, 01323-001
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicowdc@insight-trials.org
Contact:Contact: Do not include personal information in email
Brazil, SP
Associação Beneficente Hospital Universitario (Site 649-212), Av. Higino Muzi Filho, 1001-Mirante
[Not yet recruiting]
Marília, SP, Brazil, 17525-160
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicowdc@insight-trials.org
Contact:Contact: Do not include personal information in email
Brazil, Santa Catarina
Hospital Nereu Ramos (Site 649-210), Rua Rui Barbosa, 800
[Not yet recruiting]
Florianópolis, Santa Catarina, Brazil, 88025-301
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicowdc@insight-trials.org
Contact:Contact: Do not include personal information in email
Unimed Joinville Cooperativa de Trabalho Médico (Site 649-202), Rua Orestes Guimarães, 905, Bairro América
[Not yet recruiting]
Joinville, Santa Catarina, Brazil, 82204-061
Contact:Contact: If interested in participating at this site, enter site name and ACTIV-3b in subject line of email and send to tesicowdc@insight-trials.org
Contact:Contact: Do not include personal information in email
Open or close this module IPDSharing
Plan to Share IPD: Undecided Undecided
Open or close this module References
Citations:
Links:
Description: FDA Safety Alerts and Recalls
Description: FDA Safety Alerts and Recalls
Description: CDC (Centers for Disease Control and Prevention): Coronavirus (COVID-19) website
Description: CDC (Centers for Disease Control and Prevention): Coronavirus (COVID-19) website
Description: A Participant's Guide to Clinical Trials (NIAID)
Description: A Participant's Guide to Clinical Trials (NIAID)
Description: Find a Clinical Trial (NIAID)
Description: Find a Clinical Trial (NIAID)
Description: Clinical Trials at NIAID
Description: Clinical Trials at NIAID
Description: National Institute for Allergy and Infectious Diseases (NIAID)
Description: National Institute for Allergy and Infectious Diseases (NIAID)
Description: NIH COVID-19 treatment guidelines
Description: NIH COVID-19 treatment guidelines
Description: WHO COVID-19 treatment guidelines
Description: WHO COVID-19 treatment guidelines
Available IPD/Information:

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