Next stop, phase 3 clinical trials: "hopeful" results from Remdesivir study released today


Posted on 4 mins read

Just published in the NEJM.

Key findings

  • 53 patients (initially 61, 1 excluded to a dosing error and 7 with no post-treatment data)
  • 17 of 30 patients on ventilation were extubated
  • 3 or 4 patients on ECMO stopped receiving it
  • “clinical improvement was observed in 36 of 53 patients (68%)”
  • 25 of 53 were discharged
  • 7 of 53 died
  • 23% had one or more serious adverse events

Study participants were given a 10-day course of Remdesivir: an IV loading dose of 200mg and 100mg daily the following 9 days.

Follow-up was done from between 13 and 23 days after initiation of treatment (median 18 days) with the following results

The way to read this is the columns track where people were initially and the rows are where they were after follow up. So for example, 6 of 34 patients (18%) were on invasive ventilaion but ultimately died; 5 of 7 (71%) were on noninvasive ventilation and woud up discharged, etc. In general a dark grey box was a worsening of codition, a light blue improvement, light grey stayed th same in terms of oxygen support. Overall, 68% improved while 15% worsened in the time between treatment initiation and follow up.

Though there is no conrol group here, Eric Topol writes of the study

The previous reports of patients w/ #COVID19 who required intubation, on a ventilator, all have fatality rates >50%. That’s historical controls from China, Italy, and the UK and go up to 93% fatality. We need more data for remdesivir but this really a good signal for efficacy.

Another way of viewing the data, each row is a patient, the colors are the status of respiratory support

The baseline characteristics of the participants recruited from the US and 8 other countries

Note that 64% were receiving mechanical ventilation and 8% receiving ECMO.

Data on adverse events

The Washington Post spoke with the leader of the study

“We cannot draw definitive conclusions from these data, but the observations from this group of hospitalized patients who received remdesivir are hopeful,” said Dr. Jonathan D. Grein, Director of Hospital Epidemiology, Cedars-Sinai Medical Center, Los Angeles, and lead author of the journal article. “We look forward to the results of controlled clinical trials to potentially validate these findings.”

Up, next a controlled phase 3 study, most likely.

Here’s what others are saying

The next thing to look out for are results from one of the randomized controlled trials underway.

Update 4/10/20 Gilead has made some changes to their study protocol for this drug.

One reason they might do this is because they fear the effect of the drug might be too small to be sigificant without a larger sample size as this person points out.



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