Adaptive COVID-19 Treatment Trial (ACTT)
- Registration Number
- NCT04280705
- 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 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. To evaluate the clinical efficacy, as assessed by time to recovery, of different investigational therapeutics as compared to the control arm.
- 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 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.
Contacts:
20-0006 Central Contact
Telephone: 1 (301) 7617948
Email: DMIDClinicalTrials@niaid.nih.gov
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1062
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Admitted to a hospital with symptoms suggestive of COVID-19 infection.
-
Subject (or legally authorized representative) provides informed consent prior to initiation of any study procedures.
-
Subject (or legally authorized representative) understands and agrees to comply with planned study procedures.
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Male or non-pregnant female adult > / = 18 years of age at time of enrollment.
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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.
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Illness of any duration, and at least one of the following:
- Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), OR
- SpO2 < / = 94% on room air, OR
- Requiring supplemental oxygen, OR
- Requiring mechanical ventilation.
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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.
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Agrees to not participate in another clinical trial for the treatment of COVID-19 or SARS-CoV-2 through Day 29.
Exclusion Criteria:
- Alanine Transaminase (ALT) or Aspartate Transaminase (AST) > 5 times the upper limit of normal.
- Estimated glomerular filtration rate (eGFR) < 30 ml/min (including patients receiving hemodialysis or hemofiltration).
- Pregnancy or breast feeding.
- Anticipated discharge from the hospital or transfer to another hospital which is not a study site within 72 hours.
- Allergy to any study medication.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo 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 up to a 10 days total course. n=286. Remdesivir Remdesivir 200 mg of Remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of Remdesivir while hospitalized for up to a 10 days total course. n=286.
- Primary Outcome Measures
Name Time Method Time to Recovery Day 1 through Day 29 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 to Recovery by Race Day 1 through Day 29 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 to Recovery by Ethnicity Day 1 through Day 29 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 to Recovery by Sex Day 1 through Day 29 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.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Alanine Transaminase (ALT) Days 1, 3, 5, 8, 11, 15 and 29 Blood to evaluate ALT was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Change From Baseline in Aspartate Transaminase (AST) Days 1, 3, 5, 8, 11, 15 and 29 Blood to evaluate AST was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Change From Baseline in Creatinine Days 1, 3, 5, 8, 11, 15 and 29 Blood to evaluate serum creatinine was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Change From Baseline in Glucose Days 1, 3, 5, 8, 11, 15 and 29 Blood to evaluate serum glucose was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Change From Baseline in Hemoglobin Days 1, 3, 5, 8, 11, 15 and 29 Blood to evaluate hemoglobin was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Change From Baseline in Platelets Days 1, 3, 5, 8, 11, 15 and 29 Blood to evaluate platelets was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Change From Baseline in Prothrombin Time (PT) Days 1, 3, 5, 8, 11, 15 and 29 Blood to evaluate PT was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Change From Baseline in Total Bilirubin Days 1, 3, 5, 8, 11, 15 and 29 Blood to evaluate total bilirubin was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Change From Baseline in White Blood Cell Count (WBC) Days 1, 3, 5, 8, 11, 15 and 29 Blood to evaluate WBC was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Change From Baseline in Neutrophils Days 1, 3, 5, 8, 11, 15 and 29 Blood to evaluate neutrophils was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Change From Baseline in Lymphocytes Days 1, 3, 5, 8, 11, 15 and 29 Blood to evaluate lymphocytes was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Change From Baseline in Basophils Days 1, 3, 5, 8, 11, 15 and 29 Blood to evaluate basophils was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Change From Baseline in Monocytes Days 1, 3, 5, 8, 11, 15 and 29 Blood to evaluate monocytes was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Change From Baseline in Eosinophils Days 1, 3, 5, 8, 11, 15 and 29 Blood to evaluate eosinophils was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.
Change in National Early Warning Score (NEWS) From Baseline Days 1, 3, 5, 8, 11, 15, 22, and 29 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. The minimum score is 0, representing the better outcome, and the maximum value is 19, representing the worse outcome.
29-day Participant Mortality Day 1 through Day 29 The mortality rate was determined as the proportion of participants who died by study Day 29.
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 1 Day 1 The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 3 Day 3 The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 5 Day 5 The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 8 Day 8 The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 11 Day 11 The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 15 Day 15 The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 22 Day 22 The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
Percentage of Participants Reporting Serious Adverse Events (SAEs) Day 1 through Day 29 An SAE is defined as an AE or suspected adverse reaction is considered serious if, in the view of either the investigator or the sponsor, 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.
Percentage of Participants Discontinued or Temporarily Suspended From Investigational Therapeutics Day 1 through Day 10 Participants may have been discontinued from investigational therapeutics due to discharge or death. The halting or slowing of the infusion for any reason was collected, as was missed doses in the series of 10 doses.
Duration of Hospitalization Day 1 through Day 29 Duration of hospitalization was determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die.
Duration of New Non-invasive Ventilation or High Flow Oxygen Use Day 1 through Day 29 Duration of new non-invasive ventilation or high flow oxygen use was measured in days among participants who were not on non-invasive ventilation or high-flow oxygen use at baseline, determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die
Duration of New Oxygen Use Day 1 through Day 29 Duration of new oxygen use was measured in days among participants who were not on oxygen at baseline, determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die
.Duration of New Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use Day 1 through Day 29 Duration of new ventilator or ECMO use was measured in days among participants who were not on a ventilator or ECMO at baseline, determined two ways. The first includes imputations for participants who died. The second method is restricted to participants who did not die
Percentage of Participants Requiring New Non-invasive Ventilation or High-flow Oxygen Use Day 1 through Day 29 New non-invasive ventilation or high-flow oxygen use was determined as the percentage of subject not on non-invasive ventilation or high-flow oxygen at baseline.
Percentage of Participants Requiring New Oxygen Use Day 1 through Day 29 The percentage of participants requiring new oxygen use was determined as the percentage of participants not requiring oxygen at baseline
Percentage of Participants Requiring New Ventilator or Extracorporeal Membrane Oxygenation (ECMO) Use Day 1 through Day 29 The percentage of participants requiring new ventilator or ECMO use was determined as the percentage not on a ventilator or ECMO at baseline
Percentage of Participants at Each Clinical Status Using Ordinal Scale at Day 29 Day 29 The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities.
Percentage of Participants Reporting Grade 3 and 4 Clinical and/or Laboratory Adverse Events (AEs) Day 1 through Day 29 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.
Mean Change in the Ordinal Scale Day 1, 3, 5, 8, 11, 15, 22, and 29 The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities. A positive change indicates a worsening and a negative change is an improvement.
14-day Participant Mortality Day 1 through Day 15 The mortality rate was determined as the proportion of participants who died by study Day 15.
Time to an Improvement by at Least One Category Using an Ordinal Scale Day 1 through Day 29 The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 8) Death; 7) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 6) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5) Hospitalized, requiring supplemental oxygen; 4) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 3) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 1) Not hospitalized, no limitations on activities. Time to improvement by at least one category was determined for each participant
Time to an Improvement of at Least Two Categories Using an Ordinal Scale Day 1 through Day 29 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 to improvement by at least two categories was determined for each participant
Time to Discharge or to a NEWS of 2 or Less and Maintained for 24 Hours, Whichever Occurs First Day 1 through Day 29 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. The minimum score is 0, representing the better outcome, and the maximum value is 19, representing the worse outcome. The time to discharge or a NEWS of less than or equal to 2 was determined for each participant.
Trial Locations
- Locations (60)
University of Illinois at Chicago College of Medicine - Division of Infectious Diseases
🇺🇸Chicago, Illinois, United States
Johns Hopkins Hospital - Medicine - Infectious Diseases
🇺🇸Baltimore, Maryland, United States
The University of Washington - Virology Research Clinic
🇺🇸Seattle, Washington, United States
University of California Davis Medical Center - Internal Medicine - Infectious Disease
🇺🇸Sacramento, California, United States
Emory Vaccine Center - The Hope Clinic
🇺🇸Decatur, Georgia, United States
Northwestern Hospital - Infectious Disease
🇺🇸Chicago, Illinois, United States
University of California Irvine Medical Center - Infectious Disease
🇺🇸Orange, California, United States
Hospital of the University of Pennsylvania - Infectious Diseases
🇺🇸Philadelphia, Pennsylvania, United States
Universitatsklinikum Koeln Klinik I fur Innere Medizin Klinisches Studienzentrum fur Infektiologie I
🇩🇪Cologne, Germany
Cedars Sinai Medical Center
🇺🇸West Hollywood, California, United States
University of California Los Angeles Medical Center - Westwood Clinic
🇺🇸Los Angeles, California, United States
University of California San Diego Health - Jacobs Medical Center
🇺🇸La Jolla, California, United States
VA Palo Alto Health Care System - Infectious Diseases
🇺🇸Palo Alto, California, United States
University of Rochester Medical Center - Vaccine Research Unit
🇺🇸Rochester, New York, United States
Brooke Army Medical Center
🇺🇸Fort Sam Houston, Texas, United States
Universitätsklinikum Frankfurt -Medizinische Klinik II - Infektiologie
🇩🇪Frankfurt, Germany
Royal Victoria Infirmary - Department of Infectious Diseases
🇬🇧Level 6, Ward 19, Newcastle Upon Tyne, United Kingdom
AHEPA University Hospital - 1st Department of Internal Medicine
🇬🇷Thessaloniki, Central Macedonia, Greece
Naval Medical Center San Diego - Infectious Disease Clinic
🇺🇸San Diego, California, United States
University of California San Francisco - Zuckerberg San Francisco General Hospital - Division of Human Immunodeficiency Virus, Infectious Disease, and Global Medicine
🇺🇸San Francisco, California, United States
Denver Health Division of Hospital Medicine - Main Campus
🇺🇸Denver, Colorado, United States
University of Minnesota Medical Center, Fairview - Infectious Diseases and International Medicine
🇺🇸Minneapolis, Minnesota, United States
University of Nebraska Medical Center - Infectious Diseases
🇺🇸Omaha, Nebraska, United States
Duke Human Vaccine Institute - Duke Vaccine and Trials Unit
🇺🇸Durham, North Carolina, United States
Vanderbilt University Medical Center - Infectious Diseases
🇺🇸Nashville, Tennessee, United States
University of Texas Health Science Center at San Antonio - Infectious Diseases
🇺🇸San Antonio, Texas, United States
University of Alabama at Birmingham School of Medicine - Infectious Disease
🇺🇸Birmingham, Alabama, United States
Hospital Germans Trias i Pujol - Servei Malalties Infeccioses
🇪🇸Barcelona, Cataluña, Spain
Southeast Louisiana Veterans Health Care System - Section of Infectious Diseases
🇺🇸New Orleans, Louisiana, United States
Walter Reed National Military Medical Center
🇺🇸Bethesda, Maryland, United States
University of Maryland School of Medicine - Center for Vaccine Development - Baltimore
🇺🇸Baltimore, Maryland, United States
National Institutes of Health - Clinical Center, National Institute of Allergy and Infectious Diseases Laboratory Of Immunoregulation, Clinical Research Section
🇺🇸Bethesda, Maryland, United States
Saint Louis University - Center for Vaccine Development
🇺🇸Saint Louis, Missouri, United States
Montefiore Medical Center - Infectious Diseases
🇺🇸Bronx, New York, United States
New York University School of Medicine - Langone Medical Center - Microbiology - Parasitology
🇺🇸New York, New York, United States
Baylor College of Medicine - Molecular Virology and Microbiology
🇺🇸Houston, Texas, United States
University of Texas Medical Branch - Division of Infectious Disease
🇺🇸Galveston, Texas, United States
EvergreenHealth Infectious Disease Service
🇺🇸Kirkland, Washington, United States
University of Copenhagen - Centre of Excellence for Health, Immunity and Infections (CHIP) - Department of Infectious Diseases
🇩🇰Copenhagen, Denmark
Universitatsklinikum Bonn, Medizinische Klinik I - Bereich Infektiologie/HIV der Medizinischen Klinik
🇩🇪Bonn, Nordrhein-Westfalen, Germany
Madigan Army Medical Center - Infectious Disease Clinic
🇺🇸Tacoma, Washington, United States
National Center for Global Health and Medicine Hospital - Disease Control and Prevention Center
🇯🇵Tokyo, Japan
Seoul National University Bundang Hospital - Division of Infectious Diseases
🇰🇷Bundang-gu Seongnam-si, Gyeonggi-do, Korea, Republic of
Medical School of Athens University - Evangelismos Hospital - Department of Critical Care and Pulmonary Services
🇬🇷Athens, Greece
Instituto Nacional de Enfermedades Respiratorias (INER) - Ismael Cosío Villegas
🇲🇽Mexico City, Mexico
Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán - Departamento de Infectologia
🇲🇽Mexico City, Mexico
Hospital Clinic Barcelona, Servicio de Salud Internacional
🇪🇸Barcelona, Cataluña, Spain
National Centre for Infectious Diseases
🇸🇬Singapore, Singapore
Royal Sussex County Hospital - Department of Intensive Care Medicine
🇬🇧East Sussex, Brighton, United Kingdom
John Radcliffe Hospital
🇬🇧Headington, Oxford, United Kingdom
Saint Thomas' Hospital - Directorate of Infection
🇬🇧London, London, City Of, United Kingdom
Penn State Health Milton S. Hershey Medical Center - Division of Infectious Diseases
🇺🇸Hershey, Pennsylvania, United States
Stanford University - Stanford Hospital and Clinics - Pediatrics - Infectious Diseases
🇺🇸Stanford, California, United States
Massachusetts General Hospital - Infectious Diseases
🇺🇸Boston, Massachusetts, United States
University of Massachusetts Medical School - Infectious Diseases and Immunology
🇺🇸Worcester, Massachusetts, United States
Seoul National University Hospital
🇰🇷Seoul, Jongno-gu, Korea, Republic of
Providence Sacred Heart Medical Center
🇺🇸Spokane, Washington, United States
University of Virginia - Acute Care Surgery
🇺🇸Charlottesville, Virginia, United States
Naval Medical Center Portsmouth - Infectious Disease Division
🇺🇸Portsmouth, Virginia, United States
St. James's University Hospital - Infectious Diseases
🇬🇧Leeds, West Yorkshire, United Kingdom