Safety and efficacy of treatments of COVID-19 in hospitalized adults (Discovery)

Phase 1

• Conditions: COVID-19 infection; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-000936-23-CZ
• Lead Sponsor: INSERM

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-18
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 3100

Inclusion Criteria

1. Adult =18 years of age at time of enrolment.
2. Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen < 9 days hours prior to randomization.
3. Hospitalized patients with illness of any duration, and at least one of the following:
• Clinical assessment (evidence of rales/crackles on exam) AND SpO2 = 94% on room air,
OR
• Acute respiratory failure requiring supplemental oxygen, high flow oxygen devices, non-invasive ventilation, and/or mechanical ventilation.
4. Women of childbearing potential must agree to use contraception for the duration of the study. Acceptable birth control methods are listed in section

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

1. Refusal to participate expressed by patient or legally authorized representative if they are present
2. Spontaneous blood ALT/AST levels > 5 times the upper limit of normal.
3. Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR < 30 mL/min)
4. Pregnancy or breast-feeding.
5. Anticipated transfer to another hospital, which is not a study site within 72 hours.
6. Patients previously treated with one of the antivirals evaluated in the trial (i.e. remdesivir, interferon ß-1a, lopinavir/ritonavir, hydroxychloroquine) in the past 29 days
7. Contraindication to any study medication including allergy
8. Use of concomitant Ribavirin in the past 29 days and/or concomitantly to randomization

Study & Design

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