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

Phase 1

• Conditions: COVID-19 infection; MedDRA version: 23.1Level: LLTClassification code 10084401Term: COVID-19 respiratory infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-01
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1240

Inclusion Criteria

In order to be eligible to participate in this study, a patient must meet all of the following inclusion criteria:
1.Adult =18 years of age at the time of enrolment
2.Hospitalized patients with any of the following criteria:
a.the presence of pulmonary rales/crackles on clinical exam OR
b.SpO2 = 94% on room air OR
c.requirement of supplementary oxygen including high flow oxygen devices or non-invasive ventilation
3.A time between onset of symptoms and randomization of less than 9 days
4.A positive SARS-CoV-2 PCR performed on a NP swab within the 5 days preceding randomization
5.The result of a rapid antigen test performed on a NP swab within the 6 hours preceding randomization
6.Contraceptive use by men or women.
a.Male participants: Contraception for male participants is not required; however, to avoid the transfer of any fluids, all male participants must use a condom from Day 1 and agree to continue for 90 days following administration of IMP.
b.Female participants: Women of child-bearing potential must agree to use contraception for 365 days following administration of IMP. Acceptable birth control methods are listed in section 8.5.

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 600
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 640

Exclusion Criteria

An individual who meets any of the following criteria will be excluded from participation in this study:
1.Refusal to participate expressed by patient or legally authorized representative
2.Need for invasive mechanical ventilation and/or ECMO at the time of enrolment
3.Spontaneous blood ALT/AST levels > 5 times the upper limit of normal
4.Glomerular filtration rate (GFR) < 15 mL/min or requiring maintenance dialysis
5.Pregnancy or breast-feeding
6.Anticipated transfer to another hospital, which is not a study site within 72 hours following randomization
7.Known history of allergy or reaction to any component of the study drug formulation.
8.Previous hypersensitivity, infusion-related reaction, or severe adverse reaction following administration of monoclonal or polyclonal antibodies.
9.Any prior receipt of investigational or licensed vaccine or other mAb/biologic indicated for the prevention of SARS-CoV-2 infection or COVID-19 or expected receipt in the 30 days following hospital discharge, according to current recommendation in each country.
10.Any medical condition which, in the judgment of the investigator, could interfere with the interpretation of the trial results or that preludes to protocol adherence.

Study & Design

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