Randomised Evaluation of COVID-19 Therapy

RECOVERY is an interventional platform trial with the aim of testing a number of possible treatments for the disease.

Status: Open, With Recruitment in ICHT, Chelwest, LNWUH, RBHT and Hillingdon

Funder: Medical Research Council

Sponsor: University of Oxford

CI: Prof Peter Horby

IRAS-Number: 281712

CPMS-ID: 45388

Study Website: https://www.recoverytrial.net/

Information for Study Teams: https://www.recoverytrial.net/for-site-staff

Description:

Background: In early 2020, as this protocol was being developed, there were no approved treatments for COVID-19, a disease induced by the novel coronavirus SARS-CoV-2 that emerged in China in late 2019. The UK New and Emerging Respiratory Virus Threats Advisory Group (NERVTAG) advised that several possible treatments should be evaluated, including Lopinavir-Ritonavir, Interferon β, corticosteroids, and Remdesivir. These groups also advised that other treatments will soon emerge that require evaluation. A World Health Organization (WHO) expert group issued broadly similar advice.

Eligibility and randomisation: This protocol describes a randomised trial among adults hospitalised for confirmed COVID-19. Eligible patients are randomly allocated between several treatment arms, each to be given in addition to the usual standard of care in the participating hospital: No additional treatment vs Lopinavir-Ritonavir vs Interferon β1b vs low-dose corticosteroids. For patients for whom not all the trial arms are appropriate or at locations where not all are available, randomisation will be between fewer arms.

Outcomes: The main outcomes will be in-hospital death, discharge, and need for ventilation. For the main analyses, follow-up will be censored at 28 days after admission. Additional information on longer term outcomes may be collected through review of medical records or linkage to medical databases such as those managed by NHS Digital and equivalent organisations in the devolved nations.

Inclusion:

  • (i) Aged at least 18 years
  • (ii) Hospitalised
  • (iii) Confirmation of SARS-CoV-2 infection by PCR
  • (iv) 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  

Exclusion:

  • (i) 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.
  • (ii) Lopinavir-ritonavir: severe hepatic insufficiency.
  • (iii) Inhaled interferon-beta1b: severe depressive illness; severe hepatic insufficiency.
  • (iv) Dexamethasone: None