Multi-centre, adaptive, randomized trial of the safety and efficacy of treatments of COVID-19 in hospitalized adults - DisCoVeRy

Phase 1

• Conditions: COVID-19 - Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen < 72 hours prior to randomization.- 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•Requiring mechanical ventilation and/or supplemental oxygen.; Therapeutic area: Diseases [C] - Virus Diseases [C02]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-09
• Last Update Posted: 6 April 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• 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 < 72 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
•Requiring supplemental oxygen, high flow oxygen devices, non invasive ventilation and/or mechanical ventilation
4.Women of childbearing potential must agree to use at least one primary form of contraception for the duration of the study. Acceptable birth control methods are listed in section 7.3.

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 1700
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1400

Exclusion Criteria

1.Refusal to participate expressed by patient or legally authorized representative if they are present
2.Liver enzymes ALT/AST > 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 treated with one of the antivirals evaluated in the study (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 medications that are contraindicated with lopinavir/ritonavir i.e. drugs whose metabolism is highly dependent on the isoform CYP3A with narrow therapeutic range (e.g. amiodarone, colchicine, simvastatine)
9.Use of medications that are contraindicated with hydroxychloroquine: citalopram, escitalopram, hydroxyzine, domperidone, pipéraquine.
10.Human immunodeficiency virus infection under highly active antiretroviral therapy (HAART).
11.History of severe depression or attempted suicide or current suicidal ideation.

Study & Design

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