At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Adaptive Platform Treatment Trial for Outpatients With COVID-19 (Adapt Out COVID)
In Brief
A Phase 3 clinical trial evaluating bamlanivimab 7000mg, BRII-196+BRII-198, and 19 other interventions for Coronavirus and Covid19. Completed, enrolled 4,044 participants across 252 sites in 9 countries.
Detailed Summary
Drug studies often look at the effect one or two drugs have on a medical condition, and involve one company. There is currently an urgent need for one study to efficiently test multiple drugs from more than one company, in people who have tested positive for COVID-19 but who do not currently need hospitalization. This could help prevent disease progression to more serious symptoms and complications, and spread of COVID-19 in the community. This study looks at the safety and effectiveness of different drugs in treating COVID-19 in outpatients. In Phase II, participants in the study will be treated with either a study drug or with placebo. In protocol version 7.0, participants in Phase III of the study will be treated with either a study drug or active comparator drug. Participants assigned to the bamlanivimab agent/placebo arm and will have 28 days of intensive follow-up following study drug administration, followed by limited follow-up through 24 weeks in phase II and in phase III. All other investigational agents and their corresponding placebo arms will involve 28 days of intensive follow-up, followed by limited follow-up through 72 weeks in phase II and phase III. Additional study visits may be required, depending on the agent.
Study Details
Timeline
Interventions
Administered by single IV infusion. Participants are no longer being randomized to this intervention.
1000 mg (BRII-196)/1000 mg (BRII-198) combination therapy. Administered by consecutive IV infusions as single dose. Participants are no longer being randomized to this intervention.
300 mg AZD7442 (150 mg AZD8895 + 150 mg AZD1061). Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
Administered intramuscularly as 2 separate injections sequentially (300 mg AZD8895 then 300 mg AZD1061) for one dose. Injections administered in the side of the thigh, one injection in each thigh. Participants are no longer being randomized to this intervention.
1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
Administered subcutaneously (SC) as 4 separate injections for one dose (two injections of C135-LS 200mg and two injections of C144-SL 200mg). Participants are no longer being randomized to this intervention.
Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
Administered by IV infusion as single dose. Participants are no longer being randomized to this intervention.
600 mg casirivimab and 600 mg imdevimab, administered together as single IV infusion as one-time dose at study entry. Participants are no longer being randomized to this intervention.
Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
Trisodium citrate dihydrate, di-sodium hydrogen-phosphate, sodium dihydrogen-phosphate dihydrate, racemic methionine (DL-methionine) and water. 1.3 mL solution administered once daily for 14 days using Aerogen Ultra nebulizer (inhalation device). Participants are no longer being randomized to this intervention.
200 mg (2 x 100 mg) film-coated tablets administered orally every 6 hours for 7 days. Participants are no longer being randomized to this intervention.
Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
Administered SC as 4 separate injections for one dose. Participants are no longer being randomized to this intervention.
Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
Commercially available 0.9% sodium chloride solution. Participants are no longer being randomized to this intervention.
Administered by single IV infusion. Participants are no longer being randomized to this intervention.