EUCTR2020-001435-27-FR
Active, not recruiting
Phase 1
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) - COVERAGE
CENTRE HOSPITALIER UNIVERSITAIRE DE BORDEAUX, ETABLISSEMENT PUBLIC0 sites845 target enrollmentApril 1, 2020
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- severe acute respiratory syndrome coronavirus 2(SARS-CoV 2)
- Sponsor
- CENTRE HOSPITALIER UNIVERSITAIRE DE BORDEAUX, ETABLISSEMENT PUBLIC
- Enrollment
- 845
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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.
Outcomes
Primary Outcomes
Not specified
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