Table 3.
ORCHID trial | RECOVERY trial | |
---|---|---|
Design | Explanatory | Pragmatic |
Patient population | Patients admitted to hospital with COVID-19 | Patients admitted to hospital with COVID-19 |
Study setting | 34 academic medical centres | 176 hospitals (range of urban or rural, academic or community hospitals) |
Intervention(s) | Hydroxychloroquine | Hydroxychloroquine, corticosteroids, lopinavir–ritonavir, azithromycin, tocilizumab, convalescent plasma |
Control | Placebo (blinded) | Usual care (unblinded) |
Screening and enrolment | Research team | Treating clinicians |
Consent | Research team using seven-page informed consent document | Treating clinicians using one-page consent document |
Drug delivery | Investigational pharmacy (placebo-controlled) | Clinical pharmacy |
Safety monitoring | Daily assessments by research staff during the intervention period; electrocardiography according to protocol; systematic collection of safety outcomes | Patients monitored as they would be in usual care; no study-specific adverse event monitoring; systematic collection of safety outcomes71 |
Data collection | Manual collection with follow-up phone calls | Limited to in-hospital outcomes available in electronic health records |
Patients enrolled from March 2020 to June 202031, 72 (proportion of reported cases)73, 74 | 479 patients (1 in 5000 of the 2·2 million cases reported in the USA) | 11 874 patients* (1 in 25 of the 300 000 cases reported in the UK) |
Results | Hydroxychloroquine is highly unlikely to improve clinical status at 14 days after initiation of treatment | Hydroxychloroquine, lopinavir–ritonavir, azithromycin, and convalescent plasma are highly unlikely to improve mortality; dexamethasone and tocilizumab improve mortality |
ORCHID=Outcomes Related to COVID-19 Treated With Hydroxychloroquine Among Inpatients With Symptomatic Disease. RECOVERY=Randomised Evaluation of COVID-19 Therapy.
Enrolment continues in the RECOVERY trial, which had enrolled more than 45 000 patients as of May 31, 2022.