Status:
COMPLETED
Adaptive COVID-19 Treatment Trial (ACTT)
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
COVID-19
Eligibility:
All Genders
18-99 years
Phase:
PHASE3
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
February 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 21 2020
Estimated Enrollment :
1062 Patients enrolled
Trial Details
Trial ID
NCT04280705
Start Date
February 21 2020
End Date
May 21 2020
Last Update
March 14 2022
Active Locations (60)
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1
University of Alabama at Birmingham School of Medicine - Infectious Disease
Birmingham, Alabama, United States, 35233
2
University of California San Diego Health - Jacobs Medical Center
La Jolla, California, United States, 29037
3
University of California Los Angeles Medical Center - Westwood Clinic
Los Angeles, California, United States, 90095
4
University of California Irvine Medical Center - Infectious Disease
Orange, California, United States, 92868-3298