Randomised Evaluation of COVID-19 Therapy (RECOVERY) - RECOVERY trial

niversity of Oxford0 个研究点目标入组 20,000 人开始时间: 2020年3月19日最近更新: 2020年11月30日

适应症

试验速览

暂无简介。

•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

•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)

发起方