ClinicalTrials.gov

History of Changes for Study: NCT04280705
Adaptive COVID-19 Treatment Trial (ACTT)
Latest version (submitted November 13, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 February 20, 2020 None (earliest Version on record)
2 February 21, 2020 Recruitment Status, Study Status, Contacts/Locations and Oversight
3 February 27, 2020 Study Status and Contacts/Locations
4 March 3, 2020 Contacts/Locations and Study Status
5 March 5, 2020 Contacts/Locations and Study Status
6 March 6, 2020 Contacts/Locations and Study Status
7 March 12, 2020 Contacts/Locations and Study Status
8 March 18, 2020 Contacts/Locations and Study Status
9 March 19, 2020 Contacts/Locations and Study Status
10 March 20, 2020 Outcome Measures, Contacts/Locations, Study Design, Study Description, Eligibility, Arms and Interventions, Study Status and Study Identification
11 March 24, 2020 Contacts/Locations and Study Status
12 March 24, 2020 Contacts/Locations and Study Status
13 March 26, 2020 Contacts/Locations and Study Status
14 April 2, 2020 Contacts/Locations and Study Status
15 April 16, 2020 Contacts/Locations, Outcome Measures, Arms and Interventions, Study Description, Study Status, Eligibility and Study Design
16 April 23, 2020 Contacts/Locations, Study Status, Arms and Interventions and Study Design
17 April 30, 2020 Conditions and Study Status
18 May 6, 2020 Contacts/Locations and Study Status
19 July 7, 2020 Recruitment Status, Study Status, Contacts/Locations and Study Design
20 July 20, 2020 Documents and Study Status
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Results Submission Events
21 September 22, 2020 Study Status, Outcome Measures, Documents and Results
22 November 1, 2020 More Information and Study Status
23 November 13, 2020 Study Status
Comparison Format:

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Changes (Merged) for Study: NCT04280705
April 2, 2020 (v14) -- April 16, 2020 (v15)

Changes in: Contacts/Locations, Outcome Measures, Arms and Interventions, Study Description, Study Status, Eligibility and Study Design

Study Identification
Unique Protocol ID: 20-0006
Brief Title: Adaptive COVID-19 Treatment Trial (ACTT)
Official Title: A Multicenter, Adaptive, Randomized Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Adults
Secondary IDs:
Study Status
Record Verification: March 20, 2020 April 8, 2020
Overall Status: Recruiting
Study Start: February 21, 2020
Primary Completion: April 1, 2023 [Anticipated]
Study Completion: April 1, 2023 [Anticipated]
First Submitted: February 20, 2020
First Submitted that
Met QC Criteria:
February 20, 2020
First Posted: February 21, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
April 2 16, 2020
Last Update Posted: April 6 20, 2020 [Actual]
Sponsor/Collaborators
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Responsible Party: Sponsor
Collaborators:
Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Product Exported from U.S.: No
Data Monitoring:
Study Description
Brief Summary: This study is an adaptive, randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of novel therapeutic agents in hospitalized adults diagnosed with COVID-19. The study is a multicenter trial that will be conducted in up to approximately 75 100 sites globally. The study will compare different investigational therapeutic agents to a control arm. There will be interim monitoring to introduce new arms and allow early stopping for futility, efficacy, or safety. If one therapy proves to be efficacious, then this treatment may become the control arm for comparison(s) with new experimental treatment(s). Any such change would be accompanied by an updated sample size. Because background standards of supportive care may evolve/improve over time as more is learned about successful management of COVID-19, comparisons of safety and efficacy will be based on data from concurrently randomized subjects. An independent Data and Safety Monitoring Board (DSMB) will actively monitor interim data to make recommendations about early study closure or changes to study arms. Subjects will be assessed daily while hospitalized. Discharged subjects will be asked To attend study visits at Days 15 and 29. All subjects will undergo a series of efficacy, safety, and laboratory assessments. The primary objective of the study is to evaluate the clinical efficacy, as assessed by time to recovery, of different investigational therapeutics relative as compared to the control arm in adults hospitalized with COVID-19. .
Detailed Description: This study is an adaptive, randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of novel therapeutic agents in hospitalized adults diagnosed with COVID-19. The study is a multicenter trial that will be conducted in up to approximately 75 sites globally. The study will compare different investigational therapeutic agents to a control arm. There will be interim monitoring to introduce new arms and allow early stopping for futility, efficacy, or safety. If one therapy proves to be efficacious, then this treatment may become the control arm for comparison(s) with new experimental treatment(s). Any such change would be accompanied by an updated sample size. Because background standards of supportive care may evolve/improve over time as more is learned about successful management of COVID-19, comparisons of safety and efficacy will be based on data from concurrently randomized subjects. An independent data and safety monitoring board (DSMB) will actively monitor interim data to make recommendations about early study closure or changes to study arms. The initial sample size is calculated to be approximately 440 subjects, and if any additional therapeutic arms are added, the sample size will be recalculated. Subjects will be assessed daily while hospitalized. Discharged subjects will be asked to attend study visits at Days 15 and 29. All subjects will undergo a series of efficacy, safety, and laboratory assessments. The primary objective of the study is to evaluate the clinical efficacy of different investigational therapeutics relative to the control arm in adults hospitalized with COVID-19. The secondary objectives of the study are to 1) evaluate the clinical efficacy of different investigational therapeutics as compared to the control arm as assessed by clinical severity, hospitalization, and mortality, and 2) evaluate the safety of different investigational therapeutics as compared to the control arm.

This study is an adaptive, randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of novel therapeutic agents in hospitalized adults diagnosed with COVID-19. The study is a multicenter trial that will be conducted in up to approximately 100 sites globally. The study will compare different investigational therapeutic agents to a control arm. There will be interim monitoring to introduce new arms and allow early stopping for futility, efficacy, or safety. If one therapy proves to be efficacious, then this treatment may become the control arm for comparison(s) with new experimental treatment(s). Any such change would be accompanied by an updated sample size. Because background standards of supportive care may evolve/improve over time as more is learned about successful management of COVID-19, comparisons of safety and efficacy will be based on data from concurrently randomized subjects. An independent Data and Safety Monitoring Board (DSMB) will actively monitor interim data to make recommendations about early study closure or changes to study arms.

The initial sample size is projected to be 572 subjects to achieve 400 subjects with a "recovered" status (per the primary objective). The primary analysis will be based on those subjects enrolled in order to 400 recoveries. An additional analysis of the moderate severity subgroup (those with baseline status of "Hospitalized, requiring supplemental oxygen" or "Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care") is also of public health importance. Hence, enrollment will be permitted until the date of April 20, 2020 to ensure 400 recoveries and provide additional data about this important subgroup. With recent enrollment rates, the total sample size may be 600 to over 800.

Subjects will be assessed daily while hospitalized. If the subjects are discharged from the hospital, they will have a study visit at Days 15, 22, and 29 as an outpatient. For discharged subjects, it is preferred that the Day 15 and 29 visits are in person to obtain safety laboratory tests and OP swab and blood (serum only) samples for secondary research as well as clinical outcome data. However, infection control or other restrictions may limit the ability of the subject to return to the clinic. In this case, Day 15 and 29 visits may be conducted by phone, and only clinical data will be obtained. The Day 22 visit does not have laboratory tests or collection of samples and may also be conducted by phone.

All subjects will undergo a series of efficacy, safety, and laboratory assessments. Safety laboratory tests and blood (serum and plasma) research samples and oropharyngeal (OP) swabs will be obtained on Days 1 (prior to infusion) and Days 3, 5, 8, and 11 (while hospitalized). OP swabs and blood (serum only) plus safety laboratory tests will be collected on Day 15 and 29 (if the subject attends an in-person visit or are still hospitalized).

The primary outcome is time to recovery by Day 29. A key secondary outcome evaluates treatment-related improvements in the 8-point ordinal scale at Day 15. As little is known about the clinical course of COVID-19, a pilot study will be used for a blinded sample size reassessment.

Conditions
Conditions: Corona Virus Infection
Keywords: Adaptive
COVID-19
Efficacy
Multicenter
novel coronavirus
Safety
Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Double (Participant, Investigator)
Allocation: Randomized
Enrollment: 440 572 [Anticipated]
Arms and Interventions
Arms Assigned Interventions
Placebo Comparator
Placebo
200 mg of Remdesivir placebo administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir placebo while hospitalized for the duration of the hospitalization up to a 10 days total course. n= 220. 286.
Placebo
The supplied matching placebo lyophilized formulation is identical in physical appearance to the active lyophilized formulation and contains the same inactive ingredients. Alternatively, a matching placebo of normal saline of equal volume may be given if there are limitations on placebo supplies.
Experimental: Remdesivir
200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for the duration of the hospitalization up to a 10 days total course. n= 220. 286.
Drug: Remdesivir
Drug Remdesivir is a single diastereomer monophosphoramidate prodrug designed for the intracellular delivery of a modified adenine nucleoside analog GS-441524. In addition to the active ingredient, the lyophilized formulation of Remdesivir contains the following inactive ingredients: water for injection, sulfobutylether beta-cyclodextrin sodium (SBECD), and hydrochloric acid and/or sodium hydroxide.
Outcome Measures
Primary Outcome Measures:
1. Percentage of subjects reporting each severity rating on an 8-point ordinal scale Time to Recovery
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities. Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Not hospitalized, no limitations on activities.

[Time Frame: Day 15 Day 1 through Day 29]
Secondary Outcome Measures:
2. Change From Baseline in Alanine Transaminase (ALT)
Day 1 through Day 29
3. Change From Baseline in Aspartate Transaminase (AST)
Day 1 through Day 29
4. Change From Baseline in Creatinine
Day 1 through Day 29
5. Change From Baseline in Glucose
Day 1 through Day 29
6. Change From Baseline in Hemoglobin
Day 1 through Day 29
7. Change From Baseline in Platelets
Day 1 through Day 29
8. Change From Baseline in Prothrombin Time (PT)
Day 1 through Day 29
9. Change From Baseline in Total Bilirubin
Day 1 through Day 29
10. Change from baseline in white blood cell count (WBC) with differential
Day 1 through Day 29
11. Change in National Early Warning Score (NEWS) From Baseline
The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure.

[Time Frame: Day 1 through Day 29]
12. Clinical status using ordinal scale
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.

[Time Frame: Day 3 through Day 29]
13. Cumulative incidence of Grade 3 and 4 clinical and/or laboratory adverse events (AEs)

Grade 3 AEs are defined as events that interrupt usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Severe events are usually incapacitating.

Grade 4 AEs are defined as events that are potentially life threatening.



[Time Frame: Day 1 through Day 29]
14. Cumulative incidence of serious adverse events (SAEs)
An SAE is defined as an AE or suspected adverse reaction is considered serious is if, in the view of either the investigator or the sponsor, if it results in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.

[Time Frame: Day 1 through Day 29]
15. Discontinuation or temporary suspension of infusions investigational therapeutics
For any reason.

[Time Frame: Day 1 through Day 29 10]
16. Duration of Hospitalization
Measured in days.

[Time Frame: Day 1 through Day 29]
17. Duration of New Non-invasive Ventilation or High Flow Oxygen Use
Measured in days.

[Time Frame: Day 1 through Day 29]
18. Duration of new oxygen use
Measured in days.

[Time Frame: Day 1 through Day 29]
19. Duration of New Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use
Measured in days.

[Time Frame: Day 1 through Day 29]
20. Incidence of new non-invasive ventilation or high flow oxygen use
Day 1 through Day 29
21. Incidence of new oxygen use
Day 1 through Day 29
22. Incidence of new ventilator or extracorporeal membrane oxygenation (ECMO) use
Day 1 through Day 29
23. Mean change in the ordinal scale
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.

[Time Frame: Day 1 through Day 29]
24. Number of non-invasive ventilation/high flow oxygen free days
Day 1 to Day 29
25. Number of oxygenation free days Percentage of subjects reporting each severity rating on an 8-point ordinal scale
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.

[Time Frame: Day 1 to Day 29 Day 15]
26. Subject 14-day mortality
Date and cause of death (if applicable).

[Time Frame: Day 1 through Day 15]
27. Subject 28- 29-day mortality
Date and cause of death (if applicable).

[Time Frame: Day 1 through Day 29]
28. Time to an improvement of one category using an ordinal scale
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.

[Time Frame: Day 1 through Day 29]
29. Time to an improvement of two categories using an ordinal scale
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.

[Time Frame: Day 1 through Day 29]
30. Time to discharge or to a National Early Warning Score (NEWS) of </= 2 and maintained for 24 hours, whichever occurs first
The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure.

[Time Frame: Day 1 through Day 29]
31. Ventilator/extracorporeal membrane oxygenation (ECMO) free days
Day 1 through Day 29
Eligibility
Minimum Age: 18 Years
Maximum Age: 99 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  1. Admitted to a hospital with symptoms suggestive of COVID-19 infection.
  2. Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.
  3. Subject (or legally authorized representative) understands and agrees to comply with planned study procedures.
  4. Agrees to the collection of oropharyngeal (OP) swabs.
  5. Male or non-pregnant female adult > / = 18 years of age at time of enrollment.
  6. Has laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay in any specimen, as documented by either or the following:
    • PCR positive in sample collected < 72 hours prior to randomization; OR
    • PCR positive in sample collected >/= 72 hours prior to randomization, documented inability to obtain a repeat sample (e.g. due to lack of testing supplies, limited testing capacity, results taking >24 hours, etc.) AND progressive disease suggestive of ongoing SARS-CoV-2 infection.
  7. Has laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay in any specimen collected < 72 hours prior to randomization.

    Note - 72 hours is not necessarily time from initial diagnosis. If > / = 72 hours since positive PCR, the PCR may be repeated to assess eligibility.

  8. Illness of any duration, and at least one of the following:
    • Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), OR
    • Clinical assessment (evidence of rales/crackles on exam) AND SpO2 < / = 94% on room air, OR
    • Requiring supplemental oxygen, OR
    • Requiring mechanical ventilation.
  9. Women of childbearing potential must agree to either abstinence or use at least one primary form of contraception not including hormonal contraception from the time of screening through Day 29.
  10. Agrees to not participate in another clinical trial for the treatment of COVID-19 or SARS-CoV-2 through Day 29.

Exclusion Criteria:

  1. Alanine Transaminase (ALT) / or Aspartate Transaminase (AST) > 5 times the upper limit of normal.
  2. Estimated glomerular filtration rate (eGFR) < 50 30 ml/min (including patients receiving hemodialysis or requiring dialysis hemofiltration).
  3. Pregnancy or breast feeding.
  4. Anticipated discharge from the hospital or transfer to another hospital which is not a study site within 72 hours.
  5. Allergy to any study medication.
Contacts/Locations
Central Contact: 20-0006 Central Contact
Telephone: 13017617948
Email: DMIDClinicalTrials@niaid.nih.gov
Locations: United States, Alabama
University of Alabama at Birmingham School of Medicine - Infectious Disease
[Recruiting]
Birmingham, Alabama, United States, 35233
United States, California
University of California San Diego Health - Jacobs Medical Center
[Recruiting]
La Jolla, California, United States, 29037
University of California Los Angeles Medical Center - Westwood Clinic
[Recruiting]
Los Angeles, California, United States, 90095
University of California Irvine Medical Center - Infectious Disease
[Recruiting]
Orange, California, United States, 92868-3298
VA Palo Alto Health Care System - Infectious Diseases
[Recruiting]
Palo Alto, California, United States, 94304-1207
Stanford University - Stanford Hospital and Clinics - Pediatrics - Infectious Diseases
[Recruiting]
Palo Alto, California, United States, 94304-1503
University of California Davis Medical Center - Internal Medicine - Infectious Disease
[Recruiting]
Sacramento, California, United States, 95817-1460
Naval Medical Center San Diego - Infectious Disease Clinic
[Recruiting]
San Diego, California, United States, 92314
University of California San Francisco - Zuckerberg San Francisco General Hospital - Division of Human Immunodeficiency Virus, Infectious Disease, and Global Medicine
[Recruiting]
San Francisco, California, United States, 94110-2859
Cedars Sinai Medical Center
[Recruiting]
West Hollywood, California, United States, 90048-1804
United States, Colorado
Rocky Mountain Regional Veteran Affairs Medical Center - Department of Infectious Diseases
[ Not yet Recruiting]
Aurora, Colorado, United States, 80045
Denver Health Division of Hospital Medicine - Main Campus
[Recruiting]
Denver, Colorado, United States, 80204
United States, Florida
University of Florida Health Sciences Center, College - Shands Hospital - Division of Public Health- Epidemiology Infectious Diseases and Global Medicine
[ Not yet Recruiting]
Gainesville, Florida, United States, 32610 3003
United States, Georgia
Emory Vaccine Center - The Hope Clinic
[Recruiting]
Decatur, Georgia, United States, 30030-1705
United States, Illinois
Northwestern Hospital - Infectious Disease
[Recruiting]
Chicago, Illinois, United States, 60611-2908
University of Illinois at Chicago College of Medicine - Division of Infectious Diseases
[Recruiting]
Chicago, Illinois, United States, 60612
United States, Louisiana
Southeast Louisiana Veterans Health Care System (SLVHCS) - Section of Infectious Diseases
[ Not yet Recruiting]
New Orleans, Louisiana, United States, 70119
United States, Maryland
University of Maryland School of Medicine - Center for Vaccine Development - Baltimore
[Recruiting]
Annapolis, Maryland, United States, 21401-1527
Johns Hopkins Hospital - Medicine - Infectious Diseases
[Recruiting]
Baltimore, Maryland, United States, 21287-0005
Walter Reed Army Institute of Research - Clinical Trials National Military Medical Center
[Recruiting]
Silver Spring Bethesda, Maryland, United States, 20910-7500 20889
National Institutes of Health - Clinical Center, National Institute of Allergy and Infectious Diseases Laboratory Of Immunoregulation, Clinical Research Section
[Recruiting]
Bethesda, Maryland, United States, 20892-1504
United States, Massachusetts
Massachusetts General Hospital - Infectious Diseases
[Recruiting]
Boston, Massachusetts, United States, 02114-2621
University of Massachusetts Medical School - Infectious Diseases and Immunology
[Recruiting]
Worcester, Massachusetts, United States, 01655-0002
United States, Minnesota
University of Minnesota Medical Center, Fairview - Infectious Diseases and International Medicine
[Recruiting]
Minneapolis, Minnesota, United States, 55455-0341
United States, Missouri
Saint Louis University - Center for Vaccine Development
[Recruiting]
Saint Louis, Missouri, United States, 63104-1015
United States, Nebraska
University of Nebraska Medical Center - Infectious Diseases
[Recruiting]
Omaha, Nebraska, United States, 68198-5400
United States, New York
Montefiore Medical Center - Infectious Diseases
[Recruiting]
Bronx, New York, United States, 10467-2401
New York University School of Medicine - Langone Medical Center - Microbiology - Parasitology
[Recruiting]
New York, New York, United States, 10016-6402
University of Rochester Medical Center - Vaccine Research Unit
[Recruiting]
Rochester, New York, United States, 14642-0001
United States, North Carolina
Duke Human Vaccine Institute - Duke Vaccine and Trials Unit
[Recruiting]
Durham, North Carolina, United States, 27704
United States, Pennsylvania
Penn State Health Milton S. Hershey Medical Center - Division of Infectious Diseases
[ Not yet Recruiting]
Hershey, Pennsylvania, United States, 17033
Hospital of the University of Pennsylvania - Infectious Diseases
[Recruiting]
Philadelphia, Pennsylvania, United States, 19104-4238
University of Pennsylvania Perelman School of Medicine - Penn Institute for Immunology
[Not yet recruiting]
Philadelphia, Pennsylvania, United States, 19104-4863
United States, Tennessee
Vanderbilt University Medical Center - Infectious Diseases
[Recruiting]
Nashville, Tennessee, United States, 37232-0011
United States, Texas
Brooke Army Medical Center
[Recruiting]
Fort Sam Houston, Texas, United States, 78234
University of Texas Medical Branch - Division of Infectious Disease
[Recruiting]
Galveston, Texas, United States, 77555-0435
Baylor College of Medicine - Molecular Virology and Microbiology
[Recruiting]
Houston, Texas, United States, 77030-3411
University of Texas Health Science Center at San Antonio - Infectious Diseases
[Recruiting]
San Antonio, Texas, United States, 78229-3901
United States, Virginia
University of Virginia - Acute Care Surgery
[Recruiting]
Charlottesville, Virginia, United States, 22908-0816
Naval Medical Center Portsmouth - Infectious Disease Division
[Recruiting]
Portsmouth, Virginia, United States, 23708
United States, Washington
EvergreenHealth Infectious Disease Service
[Recruiting]
Kirkland, Washington, United States, 98034
The University of Washington - Virology Research Clinic
[Recruiting]
Seattle, Washington, United States, 98104-2433
Providence Sacred Heart Medical Center
[Recruiting]
Spokane, Washington, United States, 99204
Madigan Army Medical Center - Infectious Disease Clinic
[Recruiting]
Tacoma, Washington, United States, 98431
Denmark
University of Copenhagen - Centre of Excellence for Health, Immunity and Infections (CHIP) - Department of Infectious Diseases
[ Not yet Recruiting]
Copenhagen, Denmark, 2100
Germany, Nordrhein-Westfalen
Universitatsklinikum Bonn, Medizinische Klinik I - Bereich Infektiologie/HIV der Medizinischen Klinik
[ Not yet Recruiting]
Bonn, Nordrhein-Westfalen, Germany, 53127
Germany
Universitatsklinikum Koeln Klinik I fur Innere Medizin Klinisches Studienzentrum fur Infektiologie I
[Recruiting]
Cologne, Germany, 50937
Germany
Universitätsklinikum Frankfurt -Medizinische Klinik II - Infektiologie
[ Not yet Recruiting]
Frankfurt, Germany, 60590
Greece, Central Macedonia
AHEPA University Hospital - 1st Department of Internal Medicine
[Recruiting]
Thessaloniki, Central Macedonia, Greece, P.O. 54636
Greece
Medical School of Athens University - Evangelismos Hospital - Department of Critical Care and Pulmonary Services
[Recruiting]
Athens, Greece, GR-10675
Japan
National Center for Global Health and Medicine Hospital - Disease Control and Prevention Center
[Recruiting]
Tokyo, Japan, 162-8655
Korea, Republic of, Gyeonggi-do
Seoul National University Bundang Hospital - Division of Infectious Diseases
[Recruiting]
Bundang-gu Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
Korea, Republic of, Jongno-gu
Seoul National University Hospital
[Recruiting]
Seoul, Jongno-gu, Korea, Republic of, 03080
Mexico
Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán - Departamento de Infectologia
[Recruiting]
Mexico City, Mexico, 14080
Mexico
Instituto Nacional de Enfermedades Respiratorias (INER) - Ismael Cosío Villegas
[ Not yet Recruiting]
Mexico City, Mexico, 14080
Singapore
National University Health System - Division of Infectious Diseases
[Not yet recruiting]
Singapore, Singapore, 119228
Singapore General Hospital - Department of Infectious Diseases
[Not yet recruiting]
Singapore, Singapore, 169608
Singapore
National Centre for Infectious Diseases (NCID)
[Recruiting]
Singapore, Singapore, 308442
Changi General Hospital - Clinical Trials and Research Unit (CTRU)
[Not yet recruiting]
Singapore, Singapore, 529889
Ng Teng Fong General Hospital - Infectious Disease Service
[Not yet recruiting]
Singapore, Singapore, 609606
Khoo Teck Puat Hospital - Clinical Research Unit
[Not yet recruiting]
Singapore, Singapore, 768828
Spain, Cataluña
Hospital Clinic Barcelona, Servicio de Salud Internacional
[Recruiting]
Barcelona, Cataluña, Spain, 08036
Hospital Germans Trias i Pujol - Servei Malalties Infeccioses
[Recruiting]
Barcelona, Cataluña, Spain, 08916
United Kingdom, Brighton
Royal Sussex County Hospital - Department of Intensive Care Medicine
[Recruiting]
East Sussex, Brighton, United Kingdom, BN2 5BE
United Kingdom, London, City Of
Saint Thomas' Hospital - Directorate of Infection
[Recruiting]
London, London, City Of, United Kingdom, SE1 7EH
United Kingdom, West Yorkshire
St. James's University Hospital - Infectious Diseases
[Recruiting]
Leeds, West Yorkshire, United Kingdom, LS9 7TK
United Kingdom
John Radcliffe Hospital
[Recruiting]
Headington, Oxford, United Kingdom, OX3 9DU
United Kingdom, Newcastle Upon Tyne
Royal Victoria Infirmary - Department of Infectious Diseases
[Recruiting]
Level 6, Ward 19, Newcastle Upon Tyne, United Kingdom, NE1 4LP
IPDSharing
Plan to Share IPD:
References
Citations:
Links:
Available IPD/Information:

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