Enlarge /. Treatment with the antiviral drug Remdesivir shortens the recovery time in patients with COVID-19.
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Some good news in the fight against SARS-CoV-2 was released in the New England Journal of Medicine on Friday. The antiviral drug Remdesivir, originally developed as a potential treatment for Ebola, has been shown to reduce recovery time for coronavirus-infected patients. In late April, early results from this phase 3 clinical trial indicated that remdesivir could be useful in the treatment of COVID-19 patients – this new paper confirms this. It is not a cure, but the drug reduced the recovery time from an average of 15 days to 11 days.
The study included 1,059 COVID-19 patients at 60 different locations in the United States, Europe and Asia. 538 patients were treated with 10-day remdesivir treatment; The other 521 patients received placebo treatment on the same schedule. Patients were examined daily to determine both the severity of their symptoms and any side effects that could be caused by the drug, which affects the virus' ability to copy its RNA.
What did this process look like?
The main thing measured in this study was how long it took for a patient to recover. A clinical eight-point scale was used, which ranged from "not admitted to the hospital" to increasing care services to "death". The secondary results of the study included mortality two and four weeks after the start of treatment, as well as any serious side effects that occurred during the study.
There was some controversy about the study because when it started in February 2020, the primary outcome measure was how well a patient was doing on Day 15. At the end of March, however, the statisticians of the study changed this to a secondary result and replaced it with the result described above. However, these statisticians had no access to the data showing which participants received the drug and who received the placebo, and were not aware of the results. The parameters of the study were changed due to the growing awareness among scientists in these few weeks that COVID-19 was a more lengthy disease than initially thought, so it made sense to study recovery over 28 days rather than 15 days.
At the end of April it was time to look at the first results of the experiment. And these results showed sufficient clinical benefit from remdesivir, so the researchers had an ethical obligation to share their first results with the wider medical community. This also meant that patients who received the placebo could receive the drug.
11 days <15 days
Overall, treatment with remdesivir reduced a patient's recovery time compared to the placebo group from an average of 15 days to 11 days. There were improvements regardless of whether the patient received additional oxygen or not. In addition, the data serve to address all concerns that remdesivir should be administered very early after symptoms appear. In fact, those who entered the study more than 10 days after the onset of symptoms showed a better response to remdesivir than those who started treatment in the first 10 days after the symptoms.
The main secondary outcome of the study – as one participant felt on day 15 – also showed that remdesivir was significantly better than placebo. And the total number of deaths was lower in the remdesivir group at this point (21 vs. 28), although this difference was not statistically significant. (An analysis of mortality on the 28th day has not yet been completed because the admission to the study did not end until the end of April.)
The researchers found that remdesivir treatment alone is probably not enough, since at best it has a moderate impact on mortality. Therefore, studies should be investigated that combine drug treatment with other therapies. Compared to another recent study of the effects of hydroxychlorquine on COVID-19, which indicates that the drug causes a significant increase in death, this work should definitely be considered a success.
The New England Journal of Medicine, 2020. DOI: 10.1056 / NEJMoa2007764 (About DOIs).