COD-01-T01-01: Rivaroxaban for high risk people with mild COVID-19 [COVID-19] [UPH]
Research type
Research Study
Full title
INTERVENTION 1 PROTOCOL (Xarelto): A randomized, controlled, Phase 2b study to evaluate safety and efficacy of rivaroxaban (Xarelto®) for high risk people with mild COVID-19
IRAS ID
290807
Contact name
Paul Jackson
Contact email
Sponsor organisation
Bill & Melinda Gates Medical Research Institute
Eudract number
2020-005395-35
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 8 months, 29 days
Research summary
As of October 2020, approximately 41 million COVID-19 cases were reported globally with over 1,134,000 deaths. About 80% of people suffer mild to moderate disease, but severe lung infection occurs in 15-20%, particularly patients who are aged > 65 years, obese, or have ongoing conditions such as diabetes, heart or lung disease. Progression to severe lung infection frequently results in hospitalisation for oxygen therapy and may lead to ventilation and ultimately death. Early interventions to prevent disease progression are required to reduce patient suffering and burdening the healthcare system.
The main purpose of this study is to assess safety and efficacy of different inventions in reducing mild COVID-19 recovery time and reducing disease progression in patients at high risk of developing serious complications from COVID-19.
This platform study has a core protocol. A core protocol allows the simultaneous evaluation of multiple possible interventions. The first intervention being studied is rivaroxaban. Medical reports have shown that some persons with COVID-19 will have blood clots that form in the organs of the body – and blood clots in the lungs are potentially the most serious.It is hoped that by intervening early with a drug which thins the blood, it may prevent progression of mild symptoms to serious complications and severe disease.
Following a screening visit, suitable patients will receive a box containing study drug, testing kits, PPE and other study materials. They will be randomised 1:1 to receive either rivaroxaban or placebo. They will take one tablet daily for 21 days.
There will be 12 study visits from Day 1 to Day 35. Patients will be asked about their health, changes in medication and taking the study drug. On certain days they will take their temperature, oxygen reading and nose swab sample. Visits will preferably be done by phone or video call. Alternatively, patients may visit a clinic or have a home visit.
This study is sponsored by the Bill & Melinda Gates Medical Research Institute. Approximately 600 patients will participate in the rivaroxaban intervention worldwide.REC name
South West - Central Bristol Research Ethics Committee
REC reference
20/SW/0186
Date of REC Opinion
10 Dec 2020
REC opinion
Further Information Favourable Opinion