A range of potential treatments have been suggested for COVID-19 but nobody knows if any of them will turn out to be more effective in helping people recover than the usual standard of hospital care which all patients will receive.
The RECOVERY Trial will begin by testing some of these suggested treatments:
- Lopinavir-Ritonavir (commonly used to treat HIV)
- Low-dose Dexamethasone (a type of steroid, which is used in a range of conditions typically to reduce inflammation).
- Hydroxychloroquine (related to an anti-malarial drug)
- Azithromycin (a commonly used antibiotic)
- Tocilizumab (an anti-inflammatory treatment given by injection)
- Convalescent plasma (collected from donors who have recovered from COVID-19 and contains antibodies against the SARS-CoV-2 virus)
At selected sites, the RECOVERY Trial is also testing tocilizumab among participants who deteriorate after entry into the trial. Participants who meet the eligibility criteria at any time within 21 days after trial entry may be randomised into this comparison.
The eligibility criteria are:
1. Randomised into the RECOVERY Trial no more than 21 days ago
2. Clinical evidence of progressive COVID-19:
a) oxygen saturation <92% on room air or requiring oxygen; and
b) C-reactive protein ≥75 mg/L
3. 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 this aspect of the RECOVERY Trial.
Please ensure you have reviewed the training materials which include an explanation of how to access this second randomisation.
Supplies of tocilizumab are limited so regrettably it has not been possible to offer it at all our sites. Sites were selected for the second randomisation on the basis of recruitment to date, current recruitment rate and geographical location (to ensure equity around the whole UK). We realise that some sites will be disappointed. However, we have deliberately held some stock in reserve so depending on the recruitment achieved at the first group of sites, we may yet select further sites.
Please note that we need all sites to use protocol V5.0 (PIS/ICF V4.1 and PIS/ICF (children) V1).
RECOVERY AND CO-ENROLMENT WITH OTHER TRIALS
RECOVERY example second randomisation form - Both randomisation forms are for reference purposes ONLY. You can only randomise patients online.
Translations of recovery participant information sheet+ consent form
London Metropolitan University,
The Guildhall School of Business and Law and their network of translators,
The NIHR Clinical Research Network.