COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04315948

Florence Ader

Not reported

2020-03-20

Completed

RCT

Randomized

Adaptive

Blind label

multi-center

Treatment

inclusion criteria: adult ≥18 years of age at the time of enrolment hospitalized patients with any of the following criteria: the presence of pulmonary rales/crackles on clinical exam or spo2 ≤ 94% on room air or requirement of supplementary oxygen including high flow oxygen devices or non-invasive ventilation a time between onset of symptoms and randomization of less than 11 days a positive sars-cov-2 pcr performed on a np swab within the 5 days preceding randomization the result of a rapid antigen test performed on a np swab within the 6 hours preceding randomization contraceptive use by men or women. 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. female participants: women of child-bearing potential must agree to use contraception for 365 days following administration of imp

refusal to participate expressed by patient or legally authorized representative need for invasive mechanical ventilation and/or ecmo at the time of enrolment spontaneous blood alt/ast levels > 5 times the upper limit of normal glomerular filtration rate (gfr) < 15 ml/min or requiring maintenance dialysis pregnancy or breast-feeding anticipated transfer to another hospital, which is not a study site within 72 hours following randomization known history of allergy or reaction to any component of the study drug formulation. previous hypersensitivity, infusion-related reaction, or severe adverse reaction following administration of monoclonal or polyclonal antibodies. any prior receipt of investigational or licensed other 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. 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.

6

Institut National de la Santé Et de la Recherche Médicale, France

18

None

Austria;Belgium;France;Greece;Luxembourg;Norway;Portugal

Moderate/severe/critical disease at enrollment

5: Moderate/severe/critical disease at enrollment

1552

Percentage of subjects reporting each severity rating on a 7-point ordinal scale

None

Phase 3

[{"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1099, "treatment_name": "Remdesivir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1604, "treatment_name": "Lopinavir+ritonavir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1613, "treatment_name": "Interferon beta 1a+lopinavir+ritonavir", "treatment_type": "Interferons+antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1465, "treatment_name": "Cilgavimab+tixagevimab", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]