Multi-centre, adaptive, randomized trial of the safety and efficacy of treatments of COVID-19 in hospitalized adults - DisCoVeRy - DisCoVeRy

Inserm0 个研究点目标入组 75 人开始时间: 2021年3月25日最近更新: 2021年5月10日

研究概览

暂无简介。

•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

•R1. efusal to participate expressed by patient or legally authorized
•representative
•2. Need for invasive mechanical ventilation and/or ECMO at the time of
•3. Spontaneous blood ALT/AST levels > 5 times the upper limit of normal
•4. Glomerular filtration rate (GFR) < 15 mL/min or requiring maintenance
•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.

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