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Trial record 1 of 1 for:    Activ-2/A5401
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ACTIV-2: A Study for Outpatients With COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04518410
Recruitment Status : Recruiting
First Posted : August 19, 2020
Last Update Posted : May 12, 2021
Sponsor:
Collaborators:
Eli Lilly and Company
AIDS Clinical Trials Group
Brii Biosciences Limited
AstraZeneca
Sagent Pharmaceuticals
Synairgen Research Ltd.
Bristol-Myers Squibb
SAb Biotherapeutics, Inc.
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary:

Drug studies often look at the effect one or two drugs have on a medical condition, and involve one company. There is currently an urgent need for one study to efficiently test multiple drugs from more than one company, in people who have tested positive for COVID-19 but who do not currently need hospitalization. This could help prevent disease progression to more serious symptoms and complications, and spread of COVID-19 in the community.

This study looks at the safety and effectiveness of different drugs in treating COVID-19 in outpatients. Participants in the study will be treated with either a study drug or with placebo and will have 28 days of intensive follow-up following study drug administration, followed by limited follow-up through 24 weeks. Study visits may be required after week 24 depending on the study agent.


Condition or disease Intervention/treatment Phase
Coronavirus Covid19 Biological: bamlanivimab Drug: Placebo (IV) Biological: BRII-196/BRII-198 Biological: AZD7442 (IV) Biological: AZD7442 (IM) Drug: SNG001 Drug: Camostat Drug: Placebo (IM) Drug: Placebo (Inhaled solution) Drug: Placebo (oral tablet) Biological: C135-LS + C144-LS Drug: Placebo (SC injections) Biological: SAB-185 (3,840 Units/kg) Biological: SAB-185 (10,240 Units/kg) Phase 2 Phase 3

Detailed Description:

This is a master protocol to evaluate the safety and efficacy of multiple investigational agents aimed at modifying the host immune response to SARS-CoV-2 infection, or directly enhancing viral control in order to limit disease progression.

The study includes both infused and non-infused agents. For infused agents, enrollment will be restricted to participants at higher risk of progression to severe COVID-19. Non-infused agents will be open to participants at both "higher" and "lower" risk of progression to severe COVID-19.

For infused agents, the study begins with a phase II evaluation, followed by a transition into a larger Phase III evaluation for promising agents. Phase III evaluation is a continuation of the phase II trial for agents that meet study-defined criteria for further evaluation and for which sufficient investigational agent is available. An infused agent may also enter directly into phase III evaluation based on Trial Oversight Committee (TOC) assessments.

For non-infused agents, the same phase II study will be undertaken as for infused agents. Following design of the phase III evaluation for non-infused agents in a subsequent version or amendment of the protocol these may also enter directly into phase III based on TOC assessments.

Investigational agents will be selected by the TOC for phase II evaluation based on the presence of in vitro data demonstrating promise as anti-SARS-CoV-2 therapeutics in pre-clinical testing, and for which there are suitable pharmacokinetics and safety data from phase I testing, or through clinical or research testing for a different indication, and agent availability.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Unblinded data will be provided to the Data and Safety Monitoring Board for interim analyses. Unblinded Day 28 data will also be provided to a small group of people from the company who owns the investigational agent, to assist the company in deciding if the agent should move into phase 3 evaluation; or in choosing a dose of their agent to move into phase 3 evaluation.
Primary Purpose: Treatment
Official Title: Adaptive Platform Treatment Trial for Outpatients With COVID-19 (Adapt Out COVID)
Actual Study Start Date : August 19, 2020
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2023

Arm Intervention/treatment
Experimental: Bamlanivimab
Administered by IV infusion.
Biological: bamlanivimab
7000 mg or 700 mg (Phase 2), 700 mg (Phase 3). Administered by single IV infusion. Phases 2 and 3 completed for bamlanivimab. Participants are no longer being randomized to this intervention.
Other Name: LY3819253

Experimental: BRII-196/BRII-198
Administered by IV infusion.
Biological: BRII-196/BRII-198
1000 mg (BRII-196)/1000 mg (BRII-198) combination therapy. Administered by consecutive IV infusions as single dose

Experimental: AZD7442 (IV)
Administered by IV infusion.
Biological: AZD7442 (IV)
300 mg AZD7442 (150 mg AZD8895 + 150 mg AZD1061). Administered by IV infusion as single dose.
Other Name: AZD8895 + AZD1061

Experimental: Placebo (IV)
The placebo arm may be pooled across more than one experimental arm if multiple investigational drug are available to be tested at the same time and use the same method of administration. If it is not possible to use matching placebo over more than one experimental arm, additional placebo arms will be included in the study
Drug: Placebo (IV)
Commercially available 0.9% sodium chloride solution.

Experimental: SNG001
Administered by inhalation.
Drug: SNG001
1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device).

Placebo Comparator: Placebo (Inhaled solution)
The placebo arm may be pooled across more than one experimental arm if multiple investigational drug are available to be tested at the same time and administered in the same way. If it is not possible to use matching placebo over more than one experimental arm, additional placebo arms will be included in the study
Drug: Placebo (Inhaled solution)
Trisodium citrate dihydrate, di-sodium hydrogen-phosphate, sodium dihydrogen-phosphate dihydrate, racemic methionine (DL-methionine) and water. 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device).

Experimental: AZD7442 (IM)
Administered by IM injection.
Biological: AZD7442 (IM)
Administered intramuscularly as 2 separate injections sequentially (300 mg AZD8895 then 300 mg AZD1061) for one dose. Injections administered in the side of the thigh, one injection in each thigh.
Other Name: AZD8895 + AZD1061

Placebo Comparator: Placebo (IM)
The placebo arm may be pooled across more than one experimental arm if multiple investigational drug are available to be tested at the same time and administered in the same way. If it is not possible to use matching placebo over more than one experimental arm, additional placebo arms will be included in the study
Drug: Placebo (IM)
Commercially available 0.9% sodium chloride Injection, USP. Administered intramuscularly as 2 separate injections, sequentially for one dose. Injections administered in the side of the thigh, one injection in each thigh.

Experimental: Camostat
Administered as oral tablets.
Drug: Camostat
200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days.
Other Names:
  • FOY-305
  • camostat mesilate
  • camostat mesylate

Placebo Comparator: Placebo (oral tablets)
The placebo arm may be pooled across more than one experimental arm if multiple investigational drug are available to be tested at the same time and administered in the same way. If it is not possible to use matching placebo over more than one experimental arm, additional placebo arms will be included in the study
Drug: Placebo (oral tablet)
200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days.

Experimental: C135-LS + C144-LS
Administered as subcutaneous (SC) injections.
Biological: C135-LS + C144-LS
Administered subcutaneously (SC) as 4 separate injections for one dose (two injections of C135-LS 200mg and two injections of C144-SL 200mg).
Other Name: BMS-986414 + BMS-986413

Placebo Comparator: Placebo (SC injections)
The placebo arm may be pooled across more than one experimental arm if multiple investigational drug are available to be tested at the same time and administered in the same way. If it is not possible to use matching placebo over more than one experimental arm, additional placebo arms will be included in the study
Drug: Placebo (SC injections)
Administered SC as 4 separate injections for one dose.

Experimental: SAB-185 (Lower dose)
Administered by IV infusion.
Biological: SAB-185 (3,840 Units/kg)
Administered by IV infusion as single dose.
Other Name: Anti-SARS-CoV-2 Human Immunoglobulin Intravenous (Tc bovine-derived)

Experimental: SAB-185 (Higher dose)
Administered by IV infusion.
Biological: SAB-185 (10,240 Units/kg)
Administered by IV infusion as single dose.
Other Name: Anti-SARS-CoV-2 Human Immunoglobulin Intravenous (Tc bovine-derived)




Primary Outcome Measures :
  1. Duration of targeted clinical COVID-19 symptoms (Phase 2) [ Time Frame: Up to Day 28 ]
    Duration defined as the first of two consecutive days when any symptoms scored as moderate or severe as study entry (pre-treatment) are scored as mild or absent; and any symptoms scored as mild or absent at study entry are scored as absent. Symptoms: Fever or feeling feverish; cough, shortness of breath or difficulty breathing at rest or with activity; sore throat; body pain or muscle pain/aches; fatigue; headache, chills, nasal obstruction or congestion; nasal discharge (runny nose); nausea or vomiting; and diarrhea. Each symptom is scored daily by the participant as absent (score 0), mild (1), moderate (2) or severe (3)

  2. Quantification of SARS-CoV-2 RNA (Phase 2) [ Time Frame: Day 3 ]
    Measured as quantification (<LLoQ versus ≥LLoQ ) from site-collected NP (nasopharyngeal) swabs

  3. Quantification of SARS-CoV-2 RNA (Phase 2) [ Time Frame: Day 7 ]
    Measured as quantification (<LLoQ versus ≥LLoQ ) from site-collected NP (nasopharyngeal) swabs

  4. Quantification of SARS-CoV-2 RNA (Phase 2) [ Time Frame: Day 14 ]
    Measured as quantification (<LLoQ versus ≥LLoQ ) from site-collected NP (nasopharyngeal) swabs

  5. Quantification of SARS-CoV-2 RNA (Phase 2) [ Time Frame: Day 28 ]
    Measured as quantification (<LLoQ versus ≥LLoQ ) from site-collected NP (nasopharyngeal) swabs

  6. Incidence of new adverse event (AE) ≥ Grade 3 (Phase 2) [ Time Frame: Thru Day 28 ]
  7. Cumulative incidence of death from any cause or hospitalization (Phase 3) [ Time Frame: Thru Day 28 ]
    Hospitalization defined as ≥24 hours of acute care in a hospital or similar acute care facility, including Emergency Rooms or temporary facilities instituted to address medical needs of those with severe COVID-19

  8. Proportion of participants with new adverse event (AE) ≥ Grade 3 (Phase 3) [ Time Frame: Thru Day 28 ]

Secondary Outcome Measures :
  1. Duration of targeted clinical COVID-19 symptoms (Phase 3) [ Time Frame: Up to Day 28 ]
    Symptoms: Fever or feeling feverish; cough, shortness of breath or difficulty breathing at rest or with activity; sore throat; body pain or muscle pain/aches; fatigue; headache, chills, nasal obstruction or congestion; nasal discharge (runny nose); nausea or vomiting; and diarrhea. Each symptom is scored daily by the participant as absent (score 0), mild (1), moderate (2) or severe (3)

  2. Cumulative incidence of death from any cause or hospitalization (Phase 2) [ Time Frame: Thru Day 28 ]
    Hospitalization defined as ≥24 hours of acute care in a hospital or similar acute care facility, including Emergency Rooms or temporary facilities instituted to address medical needs of those with severe COVID-19

  3. Level of SARS-CoV-2 RNA from participant-collected nasal swabs (Phases 2 and 3) [ Time Frame: Thru Day 28 ]
    Measured as quantification (<LLoQ versus ≥LLoQ ) and level from participant-collected nasal swabs

  4. COVID-19 symptom severity ranking (Phases 2 and 3) [ Time Frame: From Day 0 thru Day 28 ]
    Based on symptom severity scores. Symptoms: Fever or feeling feverish; cough, shortness of breath or difficulty breathing at rest or with activity; sore throat; body pain or muscle pain/aches; fatigue; headache, chills, nasal obstruction or congestion; nasal discharge (runny nose); nausea or vomiting; and diarrhea. Each symptom is scored daily by the participant as absent (score 0), mild (1), moderate (2) or severe (3). For participants who are alive at 28 days and not previously hospitalized, the severity ranking will be based on the area under the curve (AUC) of the symptom score associated with COVID-19 disease over time. Participants hospitalized or who die during follow-up through 28 days will be ranked as worse than those alive and never hospitalized as follows (in worsening rank order): alive and not hospitalized at 28 days; hospitalized but alive at 28 days; and died at or before 28 days.

  5. Proportion of participants with ≥1 worsening symptom of COVID-19 (Phases 2 and 3) [ Time Frame: Thru Day 28 ]
    Progression of one or more COVID-19-associated symptoms to a worse status than recorded in study diary at study entry, prior to start of investigational product or placebo

  6. Time to self-reported return to usual (pre-COVID-19) health (Phases 2 and 3) [ Time Frame: Thru Day 28 ]
    As recorded in participant's study diary

  7. Cumulative incidence of death from any cause or hospitalization (Phases 2 and 3) [ Time Frame: Day 0 thru Week 24 ]
  8. Oxygen saturation level (Phase 2) [ Time Frame: Thru Day 28 ]
    Measured by pulse oximeter and categorized as <96% versus ≥96%

  9. AUC of SARS-CoV-2 RNA from site-collected nasal swabs (Phases 2 and 3) [ Time Frame: Thru Day 28 ]
    Measured by area under the curve (AUC) and above assay lower limit of quantification of quantitative SARS-CoV-2 RNA over time

  10. AUC of SARS-CoV-2 RNA from participant-collected nasal swabs (Phases 2 and 3) [ Time Frame: Thru Day 28 ]
    Measured by area under the curve (AUC) and above assay lower limit of quantification of quantitative SARS-CoV-2 RNA over time

  11. Incidence of new adverse event (AE) ≥ Grade 2 (Phase 2) [ Time Frame: Thru Day 28 ]
  12. Incidence of new adverse event (AE) ≥ Grade 2 (Phase 2) [ Time Frame: Thru Week 24 ]
  13. Incidence of new adverse event (AE) ≥ Grade 3 (Phase 3) [ Time Frame: Thru Week 24 ]
  14. Level (quantitative) of SARS-CoV-2 RNA from site-collected NP swabs (Phase 2) [ Time Frame: Day 3 ]
  15. Level (quantitative) of SARS-CoV-2 RNA from site-collected NP swabs (Phase 2) [ Time Frame: Day 7 ]
  16. Level (quantitative) of SARS-CoV-2 RNA from site-collected NP swabs (Phase 2) [ Time Frame: Day 14 ]
  17. Level (quantitative) of SARS-CoV-2 RNA from site-collected NP swabs (Phase 2) [ Time Frame: Day 28 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent.
  • Documentation of laboratory-confirmed SARS-CoV-2 infection, as determined by a molecular (nucleic acid) or antigen test from any respiratory tract specimen (e.g. oropharyngeal, nasopharyngeal (NP), or nasal swab, or saliva) collected ≤240 hours (10 days) prior to study entry and conducted an any US clinic or laboratory that has a Clinical Laboratory Improvement Amendments (CLIA) certification or its equivalent or any non-US DAIDS-approved laboratory.
  • Able to begin study treatment no later than 8 days from self-reported onset of COVID-19 related symptom(s) or measured fever, where the first day of symptoms is considered symptom day 0 and defined by the self-reported date of first reported sign/symptom from the following list:

    • fever or feeling feverish
    • cough
    • shortness of breath or difficulty breathing at rest or when active
    • sore throat
    • body pain or muscle pain/aches
    • fatigue
    • headache
    • chills
    • blocked nose/nasal congestion
    • runny nose
    • loss of taste or smell
    • nausea or vomiting
    • diarrhea
    • temperature ≥ 38°C (100.4°F)
  • One or more of the following signs/symptoms within 24 hours of participating in the study:

    • fever or feeling feverish
    • cough
    • shortness of breath or difficulty breathing at rest or when active
    • sore throat
    • body pain or muscle pain/aches
    • fatigue
    • headache
    • chills
    • blocked nose/nasal congestion
    • runny nose
    • loss of taste or smell
    • nausea or vomiting
    • diarrhea
    • temperature ≥ 38°C (100.4°F)
  • Oxygen levels of ≥92% when resting (measured by study staff within 24 hours of participating in the study). For a potential participant who regularly receives chronic supplementary oxygen for an underlying lung condition, their oxygen saturation should be measured while on their standard home oxygen supplementation level.
  • Participant must agree not to participate in another clinical trial for the treatment of COVID-19 or SARS-CoV-2 during the study period until hospitalization or 28 days after the start of the study, whichever occurs first.
  • Meet the protocol definition of being at "higher" risk of progression to severe COVID-19 (BRII-196/BRII-198, AZD7442 [IV]).
  • For participants of reproductive potential, negative serum or urine pregnancy test within 48 hours prior to study entry by any clinic or laboratory that has a CLIA certification or its equivalent, or by a point of care (POC)/CLIA-waived test. Note: Participants not of reproductive potential are eligible without requiring the use of a contraceptive method (BRII-196/BRII-198. AZD7442 [IV], AZD7442 [IM], SNG001, Camostat, SAB-185, CL135-LS+C144-LS).
  • Participants that engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives. They are strongly advised to inform their non-pregnant sexual partners of reproductive potential to use effective contraceptives for 24 weeks after investigational product is administered. Participants with pregnant partners should use condoms during vaginal intercourse through 24 weeks after investigational agent administration. Participants should refrain from sperm donation for 24 weeks after investigational agent administration (BRII-196/BRII-198, AZD7442 [IV], AZD7442 [IM], SAB-185).
  • Participants that engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives for 30 days after investigational agent administration. They are also strongly advised to inform their non-pregnant sexual partners of reproductive potential to sue effective contraceptives for 30 days after investigational agent is administered to the participant. Participants with pregnant partners should use condoms during vaginal intercourse through 30 days after last dose of investigational agent administration. Participants should refrain from sperm donation for 30 days after investigational agent administration (SNG001).
  • Participants that engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male contraceptives. They are also strongly advised to inform their non-regnant sexual partners of reproductive potential to use effective contraceptives from study entry through 90 days after study treatment. Participants with pregnant partners should use condoms during vaginal intercourse from study entry through 90 days after the last dose of the study treatment. Participants should refrain from sperm donation from study entry through 90 days after the last dose of study treatment (Camostat).
  • If participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use highly effective contraception for 24 weeks after investigational agent is administered (AZD7442 [IV], AZD7442 [IM], SAB-185).
  • If participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use effective contraception for 30 days after investigational agent is administered (SNG001).
  • If participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use effective contraception for 90 days after the last dose of treatment (Camostat).
  • If participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use highly effective contraception for at least 48 weeks after the investigational agent is administered (C135-LS+C144-LS).

Exclusion Criteria:

  • History of or current hospitalization for COVID-19.
  • For the current SARS-CoV-2 infection, any positive SARS-CoV-2 molecular test from any respiratory tract specimen collected more than 10 days prior to study entry.
  • Current need for hospitalization or immediate medical attention.
  • Any use of the following medications up to 30 days before participating in the study:

    • Hydroxychloroquine (except for long-term autoimmune diseases)
    • Chloroquine and/or ivermectin (unless used for parasitic infection)
    • Remdesivir, systemic and inhaled steroids (unless used for long-term conditions)
    • HIV protease inhibitors (unless used long-term for HIV infection)
  • Receipt of convalescent COVID-19 plasma or other antibody-based anti-SARS-CoV-2 treatment or prophylaxis at any time prior to study entry.
  • Receipt of other investigational treatments for SARS-CoV-2 any time before participating in the study (not including drugs approved and taken for other conditions/diseases).
  • Known allergy/sensitivity or hypersensitivity to study drug or placebo.
  • Any condition requiring surgery up to 7 days before participating in the study, or that is considered life threatening up to 30 days before participating in the study.
  • Currently pregnant or breastfeeding (BRII-196/BRII-198, AZD7442 [IV], AZD7442 [IM], SNG001, Camostat, SAB-185, C135-LS+C144-LS).
  • Inflammatory skin conditions that compromise the safety of intramuscular (IM) injections, or other overlying skin conditions or tattoos that would preclude the assessment of injection site reactions, per the discretion of the investigator (AZD7442 [IM]).
  • Inflammatory skin conditions that compromise the safety of subcutaneous (SC) injections, or other overlying skin conditions or tattoos that would preclude the assessment of infection site reactions, per the discretion of the investigator (C135-LS+C144-LS).
  • History of coagulopathy which, in the opinion of the investigator, would preclude IM injection, or use of oral or injectable anticoagulants (protocol provides more information on prohibited medications) (AZD7442 [IM]).
  • Use of or need for chronic supplemental oxygen (SNG001).
  • Known severe liver disease prior to enrollment (defined as ALT or AST > 5 times upper limit of normal or end stage liver disease with Child-Pugh Class C or Child-Pugh-Turcotte score ≥ 10) (Camostat).
  • Known severe kidney disease prior to enrollment (defined as estimated glomerular filtration rate (eGFR) <30 ml/min/1.73m² or on renal-replacement therapy such as peritoneal dialysis or hemodialysis (Camostat).
  • Meet the protocol definition of being at "higher" risk of progression to sever COVID-19 (C135-LS+C144-LS).

Other investigational drug protocol-defined inclusion/exclusion criteria may apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04518410


Locations
Show Show 188 study locations
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Eli Lilly and Company
AIDS Clinical Trials Group
Brii Biosciences Limited
AstraZeneca
Sagent Pharmaceuticals
Synairgen Research Ltd.
Bristol-Myers Squibb
SAb Biotherapeutics, Inc.
Investigators
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Study Chair: David Smith, MD, MAS University of California, San Diego
  Study Documents (Full-Text)

Documents provided by National Institute of Allergy and Infectious Diseases (NIAID):
Informed Consent Form: Main ICF  [PDF] March 8, 2021

Additional Information:
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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT04518410    
Other Study ID Numbers: A5401/ACTIV-2
38742 ( Other Identifier: DAIDS-ES )
First Posted: August 19, 2020    Key Record Dates
Last Update Posted: May 12, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
ACTIV-2
ACTIV2
COVID-19
Coronavirus
COVID 19
Coronaviridae Infections
Coronavirus Infections
RNA Virus Infections
Virus Diseases
Nidovirales Infections
SARS-CoV-2
SARS Coronavirus
Additional relevant MeSH terms:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Gabexate
Immunoglobulins
Immunoglobulins, Intravenous
Antibodies
Camostat
Immunologic Factors
Physiological Effects of Drugs
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Trypsin Inhibitors
Serine Proteinase Inhibitors
Anticoagulants