Home treatment of elderly patients with symptomatic SARS-CoV-2 infection (COVID-19) : a multiarm, multi-stage (MAMS) randomized trial to assess the efficacy and safetyof several experimental treatments to reduce the risk of hospitalization or death(COVERAGE trial)

Phase 1

• Conditions: severe acute respiratory syndrome coronavirus 2(SARS-CoV 2); Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2020-001435-27-FR
• Lead Sponsor: CENTRE HOSPITALIER UNIVERSITAIRE DE BORDEAUX, ETABLISSEMENT PUBLIC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-01
• Last Update Posted: 17 January 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 845

Inclusion Criteria

? Positive SARS-CoV-2 test on nasopharyngeal swab
? Onset of symptoms < 5 days prior to nasopharyngeal swabbing
? Age = 60 years old
? Valid, ambulatory person, fully capable of understanding the challenges of the trial
? No hospitalization criteria according to current recommendations
? Signed informed consent
? Covered by Health Insurance

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1057

Exclusion Criteria

?Inability to make a decision to participate (dementia, guardianship)
?Long QT syndrome, or QTc space > 500 ms
?Heart rate <50 / min
?Hyperkalemia > 5.5 mmol/L or hypokalemia < 3.5 mmol/L
?Treatment with dasatinib, nilotinib, ibrutinib, , potent inhibitors of cytochrome P450 CYP3A4 isoenzyme, potent inducers of cytochrome P450 CYP3A4 isoenzyme, repaglinide, azathioprine, 6-mercaptopurine, theophylline, pyrazinamide, warfarin.
?Hypersensitivity to any of the trial drugs, , ARA2 or sartan.
?Liver failure (stage = Child-Pugh B), stage 4 or 5 chronic kidney disease (DFG <30 mL/min/1.73 m²), person on dialysis, malabsorption syndrome, symptomatic gout/hyperuricemia, ileus, colitis or enterocolitis, chronic infection with the hepatitis B virus.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified