EUCTR2020-001113-21-GB
Active, not recruiting
Phase 1
Randomised Evaluation of COVID-19 Therapy (RECOVERY) - RECOVERY trial
ConditionsCOVID-19 (infection with SARS-CoV-2 virus)MedDRA version: 21.1Level: PTClassification code 10035737Term: Pneumonia viralSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 20.1Level: PTClassification code 10061982Term: Severe acute respiratory syndromeSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
DrugsRoActemra
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- COVID-19 (infection with SARS-CoV-2 virus)
- Sponsor
- niversity of Oxford
- Enrollment
- 20000
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients are eligible for the study if all of the following are true:
- •(i)Hospitalised
- •(ii)SARS\-CoV\-2 infection (suspected or confirmed)
- •(iii)No medical history that might, in the opinion of the attending clinician, put the patient at significant risk if he/she were to participate in the trial
- •In addition, if the attending clinician believes that there is a specific contra\-indication (see Appendix 2; section 8\.2\) to one of the active drug treatment arms, then the patient will not be excluded from randomisation to that arm.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 100
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 10000
- •F.1\.3 Elderly (\>\=65 years) yes
Exclusion Criteria
- •Participants may be excluded from receiving one or more of the possible randomised options if their medical history suggests that a treatment may be contraindicated.
- •Corticosteroids: none.
- •Azithromycin: known long QT syndrome
- •Convalescent plasma: known moderate or severe allergy to blood products
- •REGN10933\+REGN10987: IVIg use during admission for COVID\-19
- •Aspirin: age \<18 years; current use of aspirin or other antiplatelet therapy; recent bleeding that precludes use of aspirin in opinion of managing doctor
- •Colchicine:
- •Contraindications:
- •Female participants \=12 \<50 years old (as contraindicated in women of child\-bearing potential)
- •Severe hepatic impairment (defined as requiring ongoing specialist care)
Outcomes
Primary Outcomes
Not specified
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