Remdesivir preliminary results from NIAID trial published; suggest improvement in recovery time from COVID-19

As per the study, the mortality rate by day 14 was 7.1% in the remdesivir group as compared to 11.9% in the placebo group.

Myupchar May 26, 2020 08:01:30 IST
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Remdesivir preliminary results from NIAID trial published; suggest improvement in recovery time from COVID-19

On May 22, the New England Journal of Medicine (NEJM) published a study on the preliminary findings of the clinical trials by the National Institute of Allergy and Infectious Diseases (NIAID) on remdesivir. Remdesivir, an Ebola drug, is being considered as a potential treatment for COVID-19.

The study suggests that remdesivir is superior to any other standard treatment currently being given to coronavirus patients.

Remdesivir preliminary results from NIAID trial published suggest improvement in recovery time from COVID19

Representational image. AP.

NIAID had released the preliminary findings of this study in a press release on April 29, saying that patients who had received the drug had a 31% faster recovery time than those who did not and were able to leave the hospital on day 11 as compared to standard 15-day discharge time.

Following this, on May 1, the US Food and Drug Administration had given emergency use authorisation to the Gilead drug.

New information from the peer-reviewed study

The study had begun on February 21, and within 58 days (by April 10), the NIAID enrolled 1,063 COVID-19 patients from 10 different countries. Then in a random double-blind trial, all the patients were given either intravenous remdesivir or a placebo for 10 days.

By April 27, when the initial results were reviewed, 482 patients had been cured (much more than the expected number of recoveries that were needed for the trial), while 81 people had died.

Now, as per the NEJM article, all the patients were to be monitored from day 1 to day 29 of their hospitalisation and were graded on an 8-category scale. These 8 points were:

  1. Not hospitalised and no limitation of any activity
  2. Not hospitalised, limitation of activity and need for home oxygen therapy
  3. Hospitalised (usually for infection control) but not requiring any additional medical care or oxygen therapy
  4. Hospitalised with no need for supplemental oxygen but requiring medical care for either COVID-19 related or any other medical condition
  5. Hospitalised and requiring any oxygen therapy
  6. Hospitalised and requiring high-flow oxygen therapy or non-invasive ventilation
  7. Hospitalised and requiring invasive mechanical ventilation or ECMO
  8. Death

Out of the remdesivir group, 98.2% (531 patients) and 99.2% (518 patients) in placebo had received the assigned treatment, the rest had either opted out or had to discontinue the drug due to adverse events other than death.

The mean age of patients was 58.9 years, out of all the patients 64.3% were men.

By April 28, 391 patients in the remdesivir group and 340 in placebo had completed their 29-day treatment and had either recovered or died. A total of 132 in the remdesivir group and 169 in the placebo group had not yet completed the 29-day regime and 8 in remdesivir and 9 in the placebo group have opted out of the study.

As per the study, the mortality rate by day 14 was 7.1% in the remdesivir group as compared to 11.9% in the placebo group.

Adverse effects

Severe adverse effects like respiratory failure were more common in the placebo group. The most common non-serious adverse event in the remdesivir group was anaemia - 43 people as compared to 47 in the placebo group. Other adverse events included raised liver enzymes, acute kidney injury, increased blood creatinine, fever and high blood sugar. As per the study, the adverse events in both the remdesivir and placebo group were not significantly different.

After the release of the study, Dr Merdad Parsey, Chief Medical Officer at Gilead said that they are pleased to know the results of the trial. He also said that results from Gilead’s phase-3 SIMPLE-severe study (on patients that need oxygen supplementation but not mechanical ventilation) and SIMPLE-moderate study (on patients that do not need oxygen supplementation) will be available soon.

The data from the severe study support a 5-day rather than a 10-day treatment depending on the condition of the patient, while that from the moderate study will compare a 5- and 10-day treatment with standard care.

For more information, read our article on All you need to know about remdesivir.

Health articles in Firstpost are written by myUpchar.com, India’s first and biggest resource for verified medical information. At myUpchar, researchers and journalists work with doctors to bring you information on all things health.

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