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

Phase 1

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

• Registration Number: EUCTR2020-000936-23-NO
• Lead Sponsor: Inserm

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-25
• Last Update Posted: 10 May 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 75

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.
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 35
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

R1. efusal 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 a mAb.
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