The Recovery Trial will test five already approved drugs — HIV drug Lopinavir-Ritonavir, anti-inflammatory corticosteroid (dexamethasone), anti-malaria drug hydroxychloroquine and antibiotic azithromycin — on COVID-19 patients. It will also test tocilizumab on patients whose conditions worsen.
With a range of already approved drugs now being tested on COVID-19 patients, there is no clarity on which drug will turn out to be more effective in treating these patients compared with standard of hospital care which all patients receive. The Recovery Trial aims to study the effectiveness of four different drugs, and an anti-inflammatory drug tocilizumab for patients with worsening clinical symptoms.
The Recovery trial, which is co-ordinated by the Nuffield Department of Population Health at the University of Oxford, will randomise patients to receive either standard of care or one of the four already approved drugs. The drugs that are being tested are HIV drugs Lopinavir (400 mg)-Ritonavir (100 mg), anti-inflammatory corticosteroid (dexamethasone), anti-malaria drug hydroxychloroquine and antibiotic azithromycin (500 mg).
Patients already enrolled in the trial and have progressive COVID-19 with clinical evidence of hypoxia and inflammatory state may undergo a second randomisation to receive either tocilizumab (which blocks the inflammatory protein called IL-6) or no additional treatment.
“The trial hopes to recruit 12,000 patients in all and will receive one of the four drugs or the standard of care for 10 days or till date of hospital discharge and a second randomisation to receive tocilizumab or no treatment. The trial will be conducted across 170 hospitals in the UK, including Bradford Institute for Health Research,” says Dr. Dinesh Saralaya, Consultant Respiratory Physician & Director for Clinical Research at the Bradford Institute for Health Research and the Principal investigator of the trial at Bradford. “We have already recruited over 100 patients.”
Primary & secondary objectives
“The primary objective of the Recovery trial is to provide reliable estimates of the effect of study treatments on all-cause mortality within 28 days after randomisation,” says Dr. Saralaya. The secondary outcomes to be evaluated are reduction in hospital stay, number of patients who needed ventilation and the number of days it was required, and number of patients who needed renal replacement therapy.