Status:
COMPLETED
Trial of Treatments for COVID-19 in Hospitalized Adults
Lead Sponsor:
Institut National de la Santé Et de la Recherche Médicale, France
Conditions:
Corona Virus Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
DisCoVeRy is a randomized controlled trial among adults (≥18-year-old) hospitalized for COVID-19. This study is an adaptive, randomized, open or blinded, depending on the drug to be evaluated, clinica...
Detailed Description
DisCoVeRy is a randomized controlled trial among adults (≥18-year-old) hospitalized for COVID-19. This study is an adaptive, randomized, open or blinded, depending on the drug to be evaluated, clinica...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
March 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 25 2023
Estimated Enrollment :
1552 Patients enrolled
Trial Details
Trial ID
NCT04315948
Start Date
March 22 2020
End Date
September 25 2023
Last Update
September 19 2024
Active Locations (62)
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1
Medizinische Universität Innsbruck
Innsbruck, Austria, 6020
2
Kepler Universitätsklinikum Linz
Linz, Austria
3
Landeskrankenhaus Salzburg Universitätsklinikum der Paracelsus Medizinischen Privatuniversität
Salzburg, Austria, 5020
4
Hôpital Erasme - Cliniques universitaires de Bruxelles
Brussels, Belgium, 1070