Preliminary results from a placebo-controlled study of remdesivir
Researchers in North America, Europe and Asia conducted a randomized, placebo-controlled study of remdesivir in adults hospitalized with COVID-19. Analysis found that, overall, the time needed for participants to recover was shorter in people who received remdesivir (11 days) vs. placebo (15 days). These results were statistically significant. After 14 days of monitoring, 7% of people given remdesivir had died vs. 12% who were given placebo. However, this difference in survival was not statistically significant.
Study details
Researchers randomly assigned 531 people to receive remdesivir and 522 to receive placebo. Both interventions were given intravenously once daily. Remdesivir was given at a dose of 200 mg on day one, followed by subsequent doses of 100 mg daily for nine consecutive days.
The average profile of participants upon entering the study was as follows:
- age – 59 years
- 64% men, 36% women
- common underlying conditions: higher-than-normal blood pressure – 50%; obesity – 37%; type 2 diabetes – 30%
- proportion of participants with at least one underlying condition – 27%; proportion of participants with two or more underlying conditions – 52%
Results
Overall, participants who received remdesivir recovered faster—11 days vs. 15 days in people who received placebo. This was statistically significant. Although fewer people who received remdesivir died (7%) compared to people who received placebo (12%), this difference was not statistically significant. In the interim analysis released to date, data were collected for only the first 14 days of the study. Further monitoring is ongoing, and participants will be monitored for up to 28 days.
Adverse events
The term adverse events encompasses all unfortunate incidents that can occur during a clinical trial, including drug side effects, symptoms related to the underlying disease process and even issues unrelated to the study, such as accidents.
According to the study team, there was a range of problems that were “slightly more common among patients in the placebo group,” including the following:
- acute respiratory failure
- severely low blood pressure
- viral pneumonia
- acute kidney injury
Serious and/or life-threatening adverse events occurred in 156 people distributed as follows:
- remdesivir – 29%
- placebo – 33%
According to the study team, the distribution of adverse events was generally similar between remdesivir and placebo groups, with the exception of the following:
Anemia or decreased hemoglobin
- remdesivir – 8%
- placebo – 9%
Acute kidney injury and other kidney-related issues
- remdesivir – 7.4%
- placebo – 7.3%
Fever
- remdesivir – 5%
- placebo – 3%
Higher-than-normal levels of blood sugar
- remdesivir – 4%
- placebo – 3%
Higher-than-normal levels of liver enzymes in the blood
- remdesivir – 4%
- placebo – 6%
Bear in mind
Reflecting on these results, the study team made the following statements:
- “Our findings highlight the need to identify COVID-19 cases and start antiviral treatment before the pulmonary disease progresses to require mechanical ventilation.”
- “…given the high mortality despite use of remdesivir, it is clear that treatment with an antiviral drug alone is not likely to be sufficient.”
We will have more about remdesivir in the next article.
—Sean R. Hosein
REFERENCES:
- Dolin R, Hirsch MS. Remdesivir – an important first step. New England Journal of Medicine. 2020; in press.
- Goldman JD, Lye DCB, Hui DS, et al. Remdesivir for 5 or 10 days in patients with severe Covid-19. New England Journal of Medicine. 2020; in press.
- Wang Y, Zhang D, Du G, et al. Remdesivir in adults with severe COVID-19: a randomised, double-blind, placebo-controlled, multicentre trial. Lancet. 2020 May 30;395(10238):1694.
- Beigel JH, Tomashek KM, Dodd LE, et al. Remdesivir for the treatment of Covid-19 – preliminary report. New England Journal of Medicine. 2020; in press.