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Adaptive COVID-19 Treatment Trial (ACTT)
Not Recruiting
Trial ID: NCT04280705
Purpose
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.
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
Stanford Investigator(s)
Nidhi Rohatgi, MD MS
Clinical Professor, Medicine Clinical Professor (By courtesy), Neurosurgery
Andre Kumar MD, MEd
Clinical Associate Professor, Medicine
Evelyn Bin Ling
Clinical Assistant Professor, Medicine
Eligibility
Inclusion Criteria:
1. Admitted to a hospital with symptoms suggestive of COVID-19 infection.
2. Subject (or legally authorized representative) provides 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. Male or non-pregnant female adult > / = 18 years of age at time of enrollment.
5. 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:
1. PCR positive in sample collected < 72 hours prior to randomization; OR
Exclusion Criteria:
2. 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.
6. Illness of any duration, and at least one of the following:
1. Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), OR
2. SpO2 < / = 94% on room air, OR
3. Requiring supplemental oxygen, OR
4. Requiring mechanical ventilation.
7. 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.
8. 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) < 30 ml/min (including patients receiving
hemodialysis or 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.
Intervention(s):
other: Placebo
drug: Remdesivir
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
NIH sponsored
6504935000