Interim results of the randomised, controlled, double blind phase III CAP-China remdesivir 1 trial demonstrated that remdesivir for up to 5 days was superior to standard of care (SoC) in improving the clinical status by day 11 in patients (n = 584) with mild or moderate COVID-2019 infections. By day 11, two-point improvement on the ordinal scale occurred in 70% of patients in the 5 day remdesivir arm, 65% in the 10 day remdesivir arm, and 61% in the SoC arm. Patients in the 5 day remdesivir arm were significantly more likely to have an improvement in clinical status than those receiving SoC (odds ratio [OR], 1.65; 95% confidence interval [CI]: 1.09-2.48; p = 0.017). The OR of improvement for the 10 day remdesivir arm compared to SoC was 1.31 (95% CI: 0.88-1.95]; p = 0.183). This improvement in the 5 day remdesivir arm over the SOC arm was noted from day 6 through day 11. A peak of discharge corresponding with the assigned treatment duration of remdesivir was observed, with increased discharges at day 6 in the 5 day remdesivir arm and at day 11 in the 10 day remdesivir arm. A worsening of clinical status of ≥ 1 point in the ordinal scale was observed more commonly in the SoC am (n = 19, 10%) versus the 5 day remdesivir (n = 7, 4%) and 10 day remdesivir (n = 9, 5%) arms.

Results from the phase III CAP-China remdesivir 1 trial demonstrated that remdesivir was well tolerated with grade 3 and grade 4 adverse events compared to fewer serious adverse events in 5 day and 10 day arm. Most common adverse events include nausea, headache and hypokalemia. Incidence of adverse events leading to discontinuation and death were low and no clinically relevant changes in laboratory parameters were observed. No statistically significant change was observed in renal and liver function tests between the remdesivir 5 day and 10 day groups compared to the standard of care only group at day 14 ^[2] . The further analysis of remdesivir effect on renal function in patients with COVID-19 infections demonstrated that patients treated with remdesivir (n=822) reported less frequent acute kidney injury events, compared with the patients receiving standard of care treatment (n=183) (7% vs 10%, p=0.03). After adjustment for age, remdesivir was not significantly associated with the risk of acute kidney injury compared to standard of care (RR=0.66; 95% CI 0.40, 1.09). Patients with baseline estimated glomerular filtration rate (eGFR) >90 ml/min reported more acute kidney injury events, with few events occurring in patients with a baseline eGFR 50-59 ml/min. At day 14, in patients with stage 3 acute kidney injury, creatinine values returned to baseline after treatment with remdesivir (n=2, 0.2%), while it remained elevated in patients receiving standard of care treatment (n=4, 2%). No difference in acute kidney injury was observed between treatment arms in patients with a history of chronic kidney disease (remdesivir: n=6 [12%] vs standard of care: n=2 [40%]; p=0.14). The open-label trial evaluated 1005 patients with similar creatinine and eGFR values in both the treatment arms, collected through day 14 ^[3]