COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-000936-23/GR

INSERM - Christelle DELMAS

christelle.delmas@inserm.fr

2021-08-25

Completed

RCT

Randomized

Adaptive

Blind label

multi-center

Treatment

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 11 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 required 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.

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 mAb/biologic indicated for the prevention of SARS-CoV-2 infection or COVID-19, and for those not vaccinated, expected receipt of vaccine 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.

2

INSERM

18

100

Turkey;France

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

75

Clinical status of subject on Day 15 (on a 7-point ordinal scale): 1. Not hospitalized, no limitations on activities. 2. Not hospitalized, limitation on activities. 3. Hospitalized, not requiring supplemental oxygen. 4. Hospitalized, requiring supplemental oxygen. 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices. 6. Hospitalized, on invasive mechanical ventilation or ECMO. 7. Death.

nan

Phase 3

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