"People's hope" has not yet come true: Remdesivir still needs to be verified

The results of remdesivir in treating COVID-19 are promising, but the experiment has flaws: it was not double-blind, the sample size was too small, and it still needs to be verified.

Written by | Shi Jun

Today, Gilead announced the results of a study on the efficacy of Remdesivir against COVID-19. The data was published in the New England Journal of Medicine.

53 severely ill hospitalized COVID-19 patients received remdesivir on a compassionate basis. Some of these patients had oxygen saturation ≤ 94% during normal breathing, and some required oxygen support. The subjects received a 10-day course of remdesivir, with 200 mg intravenously administered on the first day and 100 mg per day for the remaining 9 days of treatment.

Thirty of the patients were already intubated before taking the drug, and four patients used ECMO. After tracking for 18 days (median value), 36 (68%) patients who used remdesivir had improved oxygen support levels. 17 of the 30 intubated patients were extubated, and 3 of the 4 ECMO patients did not need ECMO. A total of 25 patients (47%) were discharged from the hospital, and 7 patients (13%) died; the mortality rate of intubated patients was 18% (6 of 34), and the mortality rate of non-intubated patients was 5% (1 of 19).

However, this experiment still has many flaws, such as:

1) The sample size was too small. The original plan was to include 61 patients, but data for 8 patients were missing, including 7 patients with no post-treatment data and 1 patient with a medication error.

2) It is not a randomized double-blind trial, after all, many patients can recover on their own.

The efficacy of remdesivir still needs further verification. But the results still look promising.

Just two days ago, Gilead made major mid-term changes to its two ongoing clinical trials of remdesivir, tripling the sample size tested and switching the primary endpoint of the clinical trial.

The two clinical trials were originally designed to recruit 1,000 patients with moderate or severe COVID-19. The primary clinical endpoint for moderate patients was the proportion of patients discharged from the hospital within 14 days. The primary clinical endpoint for severe patients was the improvement of fever and blood oxygen saturation within 14 days.

After the change, the trial size for severe patients increased from 400 to 2,400 subjects. The clinical trial for moderate patients will increase its recruitment target from 600 to 1,600 subjects.

The primary clinical endpoint was also changed to a 7-point assessment, including the probability of improvement in seven aspects from never being hospitalized to death.

It is hoped that these two large clinical trials can give a more positive result. If patients taking the placebo need 16 days to improve their symptoms, then remdesivir needs to shorten the improvement time to about 13 days to achieve statistical significance.

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