RANDOMISED EVALUATION OF COVID-19 THERAPY (RECOVERY)

Phase 1

• Conditions: COVID-19 (infection with SARS-CoV-2 virus); MedDRA version: 21.1Level: PTClassification code 10035737Term: Pneumonia viralSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 20.1Level: PTClassification code 10061982Term: Severe acute respiratory syndromeSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001113-21-GB
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-19
• Last Update Posted: 30 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 20000

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
F.1.3.1 Number of subjects for this age range 10000

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)
•Significant cytopaenia (e.g. neutrophil count <1.0 x109/L; platelet count <50 x109/L; reticulocyte count <20 x109/L [if available])
•Concomitant use of strong CYP3A4 inhibitor (e.g. clarithromycin, erythromycin, systemic azole antifungal, HIV protease inhibitor) or P-gp inhibitor (e.g. ciclosporin, verapamil, quinidine).

Cautions: dose frequency should be halved (i.e. 500 mcg once daily) in the following circumstances. If >1 of these is present, investigator should consider not including colchicine in randomisation.
•Concomitant use of moderate CYP3A4 inhibitor (e.g. diltiazem)
•Renal impairment: eGFR <30 mL/min/1.73m2 (either chronic or acute)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to provide reliable estimates of the effect of study treatments on death within 28 days of randomisation (with subsidiary analyses of cause of death).;Secondary Objective: The secondary objectives are to assess the effects of study treatments on duration of hospital stay and on need for (and duration of) ventilation or renal replacement therapy.;Primary end point(s): All-cause mortality within 28 days of randomisation.;Timepoint(s) of evaluation of this end point: 28 days after randomisation.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Duration of hospitalisation<br>Use of ventilation<br>;Timepoint(s) of evaluation of this end point: 28 days