Table 2.
Trials/studies involving Remdesivir.
| Study type | Trial outcome and design | Conclusion | Comments |
|---|---|---|---|
| Case report [21] | A case of 40 years old critically ill man tested positive for COVID-19 and treated with chloroquine along with supportive therapy for 5 days, until remdesivir could be supplied on day 9 of hospitalization (days 13 of symptoms onset). 60 h later, patient was extubated and clinically improved and progressed for discharge. | Late initiation of remdesivir may still be effective in treating COVID-19 patient. | Remdesivir can provide effective improvement in COVID-19 patients based on this case report, a larger randomized control trial needed to prove it. |
| Randomized, double-blind, placebo-controlled [22] | 237 patients with severe COVID 19 enrolled and randomly assigned (2:1 ratio) to a 158 receiving remdesivir and 79 to placebo. | No statistically significant benefit of remdesivir treatment noted, however, numerically, reduction in time to clinical improvement found in remdesivir group. | Many adverse events reported in remdesivir group also found in placebo, hence it could be disease induced or any other common component of standard care. |
| Clinical improvement results showed no significant difference between both groups and numerically shorter time in remdesivir group among patients with symptom duration of 10 days or less | |||
| Remdesivir group was associated with higher adverse events compared to control (102/155 (66%), 50/78 (64%); respectively) and was stopped early in 18 (12%) compared to four (5%) patients who stopped placebo. | |||
| Open-label, Phase 3 randomized controlled trial [23] | 1063 patient with COVID-19 randomized to either receive remdesivir or placebo for the duration of hospitalization, up to total 10 days. Data suggest that the Remdesivir group were 65% more likely to have clinical improvement at Day 11 (median time to recover of 11 days vs 15 days). Mortality rate was numerically lower in remdesivir group without significant difference (8% vs 11.6%, p = 0.059). | Remdesivir was better than placebo from the perspective of the primary endpoint, time to recovery, a metric often used in influenza trials. | Preliminary report of results, more details about the results needed to confirm the clinical efficacy and safety of remdesivir for treating COVID-19 patients. |
| Open-label, Phase 3 randomized controlled trial [24] | 397 severe COVID-19 patients were randomized in a 1:1 ratio to receive remdesivir 200 mg IV on the first day, followed by remdesivir 100 mg IV each day in addition to standard of care to evaluate the efficacy and safety of 5-day (n = 200) or 10-day dosing duration. | Patients receiving a 10-day treatment course of remdesivir achieved similar improvement in clinical status compared with those taking a 5-day treatment course. | Data provided recently confirms efficacy and better tolerability of 5 days treatment than 10 days. |
| Preliminary results show higher efficacy outcomes at day-14 were found in patients with 5-day duration with no significant difference were noticed between both groups in clinical recovery (129 (65%) vs 106 (54%)) and death (16 (8%) vs 21 (11%), p value = 0.70). | |||
| More number of patients with 10-day duration discontinued the medications due to serious side effects. | |||
| Retrospective cohort study [25] | 53 patients with severe COVID 19 received 10-day course of Remdesivir. At baseline, 30/53 (57%) were receiving mechanical ventilation and 4/53 (8%) were receiving extracorporeal membrane oxygenation and followed up for any clinical improvement. Day 18 of follow up, 36/53 (68%) had an improvement in oxygen-support, including 17 /30 (57%) who were on mechanical ventilation were extubated. A total of 25/53 (47%) were discharged, and 7/53 (13%) died (18% (6 out of 34 among patients receiving invasive ventilation). | Remdesivir showed clinical improvement in 36/53(68%) severe COVID-19 patients. | Remdesivir showed improvement in 68% of patients and high mortality also in 13% of the patient. Thus using remdesivir for treating COVID-19 patients is controversial and need a larger randomized control trial. |