Adaptive COVID-19 Treatment Trial (ACTT)

Completed · Phase 3 · Has a placebo group

Conditions studied: COVID-19

In brief

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.

Key facts

Study ID

NCT04280705

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

1062

Starts

2020-02-21

Expected to finish

2020-05-21

Last updated by the study team

2022-03-14

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Male or non-pregnant female adult > / = 18 years of age at time of enrollment.
• 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

You may not qualify if…

• 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.
• 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.
• 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.
• 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.

Where it is running

• University of California San Diego Health - Jacobs Medical Center — La Jolla, California, United States
• University of California Los Angeles Medical Center - Westwood Clinic — Los Angeles, California, United States
• University of California Irvine Medical Center - Infectious Disease — Orange, California, United States
• VA Palo Alto Health Care System - Infectious Diseases — Palo Alto, California, United States
• University of California Davis Medical Center - Internal Medicine - Infectious Disease — Sacramento, California, United States
• 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
• Stanford University - Stanford Hospital and Clinics - Pediatrics - Infectious Diseases — Stanford, California, United States
• Cedars Sinai Medical Center — West Hollywood, California, United States
• Denver Health Division of Hospital Medicine - Main Campus — Denver, Colorado, United States
• Emory Vaccine Center - The Hope Clinic — Decatur, Georgia, United States
• Northwestern Hospital - Infectious Disease — Chicago, Illinois, United States
• University of Illinois at Chicago College of Medicine - Division of Infectious Diseases — Chicago, Illinois, United States
• Southeast Louisiana Veterans Health Care System - Section of Infectious Diseases — New Orleans, Louisiana, United States
• University of Maryland School of Medicine - Center for Vaccine Development - Baltimore — Baltimore, Maryland, United States
• Johns Hopkins Hospital - Medicine - Infectious Diseases — Baltimore, Maryland, United States
• Walter Reed National Military Medical Center — Bethesda, 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
• Massachusetts General Hospital - Infectious Diseases — Boston, Massachusetts, United States
• University of Massachusetts Medical School - Infectious Diseases and Immunology — Worcester, Massachusetts, United States
• University of Minnesota Medical Center, Fairview - Infectious Diseases and International Medicine — Minneapolis, Minnesota, United States
• Saint Louis University - Center for Vaccine Development — St Louis, Missouri, United States
• University of Nebraska Medical Center - Infectious Diseases — Omaha, Nebraska, United States
• New York University School of Medicine - Langone Medical Center - Microbiology - Parasitology — New York, New York, United States
• University of Alabama at Birmingham School of Medicine - Infectious Disease — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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