Adaptive COVID-19 Treatment Trial (ACTT)
A Multicenter, Adaptive, Randomized Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalised Adults
Funder: National Institutes of Health (NIH), United States
Sponsor: University of Minnesota (USA)
CI: Dr Sarah Pett
Approval Date: 27 March 2020
This multi-centre trial (ACTT/INSIGHT-10) is a double-blind placebo-controlled trial, of the antiviral drug, remdesivir, for the treatment of COVID-19 infection in adults in hospital. This means neither the patients nor doctors know who is receiving remdesivir and who is receiving a drug containing no active ingredient (placebo). In total, at least 800 patients from approximately 100 sites in the USA, Mexico, UK, Europe, and SE Asia will be included in the trial. All patients will receive normal hospital treatment as well as one of the following treatments, assigned by chance: a daily intravenous infusion of remdesivir (active drug). There is a 1 in 2 chance of being in this group. a daily saline infusion (placebo infusion with no active ingredient). There is a 1 in 2 chance of being in this group. Treatment will be given for a maximum of 10 days and only whilst the patient is in hospital. The trial will last for 29 days. The main way of seeing how well the treatment works will be the time to recovery over 29 days of follow-up. Getting better (recovery) in the trial was defined as being still in the hospital and off oxygen, or out of hospital and either back to partial or complete return to health status before getting COVID-19. Patients will have clinical, safety and laboratory measurements taken up to 7 times during the study, in patients who have left hospital the visits at Day 15, 22 and 29 can be done on the phone, rather than asking patients to come back in for review. Optional blood samples will be taken to assess safety and to measure virus levels, immune response (body's defences) and inflammation levels. These samples will be taken on Day 1 of the trial (before treatment), on Days 3, 5, 8, 11 (whilst in hospital) and also on Days 15 and 29, if patients are still in hospital on these days. Swabs from the mouth and throat (oropharyngeal) will be taken on the same days to measure the virus levels later on. High-level results for the first stage of the trial were reported on 29th April 2020. These showed remdesivir sped up recovery from COVID-19. This resulted in a fast track emergency approval by the drug regulatory authorities in the USA (the FDA) of remdesivir for patients hospitalised with COVID-19, meeting the following criteria: proven or suspected COVID-19 in hospital on mechanical ventilation or receiving Oxygen therapy or having low oxygen levels without Oxygen therapy.
SARS-Cov-2, an emergent respiratory pathogen, and the cause of COVID-19 illness, is now a global pandemic. 20% of people, usually older with other health problems, are more severely affected, and many deaths have occurred. There are no approved treatments, or vaccines, and hence there is an urgent need to assess the efficacy/safety of antivirals and other therapeutics to treat COVID-19. The Multicenter, Adaptive, Randomized Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Adults(INSIGHT-10), is a double-blind placebo-controlled trial, of the anti-viral, remdesivir, for the COVID-19 treatment in hospitalised adults. This RCT is testing whether a daily intravenous infusion of remdesivir(active drug) compared to N-saline placebo, provides clinical benefit, and is safe. There is a 50:50 chance of remdesivir or N-saline placebo; all participants will receive standard supportive treatments. The maximum number of doses is 10, and only while hospitalised. There are 9 study visits during the 29 days on study. Participants will have clinical, safety and laboratory assessments at each visit, except for the Day 22 visit, which can be conducted by phone if the participant is discharged. Optional blood samples (for safety and to later measure virus levels/immune response/inflammation levels) and oropharyngeal(OP) swabs will be obtained on Day 1 (before infusion); 3, 5, 8, 11 (while hospitalised); and Day 15 and 29. In total, 440 hospitalised COVID-positive adults will be randomised in the USA/Europe/UK/SE Asia, from approximately 75 sites. The primary outcome evaluates the clinical status of the participant on Day 15 on an 8-point scale. As we know very little about the clinical course of COVID-19, an analysis will be done, after the first 100 participants to check that Day 15 is the best day to assess the effects of remdesivir. If it isn't, the protocol will be updated.
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