But it's not a miracle drug, since 13% died and 19% worsened or saw no change.
By Molly Walker, Associate Editor, MedPage Today
Researchers found that nearly two-thirds of patients with severe COVID-19 coronavirus treated with the antiviral agent Remdesivir showed clinical improvement.
Approximately one-third did not, including seven patients who died, out of the first 53 patients who received remdesivir under "compassionate use" for whom the data were analyzed.
In that group, 68% experienced improved oxygen delivery , reported Diana Brainard, MD, of the pharmaceutical company Gilead Sciences, and colleagues in the New England Journal of Medicine . With a median follow-up of 18 days, the overall mortality rate was 13%.
Among those who received invasive ventilation, 18% died (n = 6). Brainard and colleagues reported a mortality rate of 5% (n = 1) among those who did not receive invasive ventilation. The median interval between the start of remdesivir and death was 15 days.
Seventeen of the 30 patients who received mechanical ventilation were extubated, and three of the four who received extracorporeal membrane oxygenation (ECMO) all survived at the last follow-up.
This was an observational report on the initial cohort of patients who received the drug under compassionate use, and therefore there was no control group.
“To date, no therapy has demonstrated efficacy in patients with COVID-19,” the authors wrote. “Although data from several ongoing randomized controlled trials will soon provide further evidence on the safety and efficacy of remdesivir for COVID-19, the results observed in this compassionate use program are the best clinical data currently available.”
The authors were limited by a lack of data on viral load, the small sample size, the short follow-up period, and the absence of a control group. However, they concluded, “Comparisons with cohorts in the literature… suggest that remdesivir may have a clinical benefit in patients with severe COVID-19.”
Brainard and colleagues added that ongoing randomized, placebo-controlled trials of remdesivir therapy for COVID-19 will provide a better understanding of the drug's effectiveness.
Remdesivir has been studied as a potential therapy for COVID-19 since the early days of the outbreak, and the company began accepting compassionate use applications on January 25. The drug has broad-spectrum in vitro activity against coronaviruses, such as SARS-CoV and MERS-CoV, and filoviruses such as Ebola; however, previous clinical trials showed it was not effective against Ebola infection in humans.
Patients with confirmed COVID-19 and oxygen saturations of 94% or less while breathing room air or receiving oxygen received a 10-day course of remdesivir.
Overall, 61 patients received at least one dose of remdesivir on or before March 7, with eight excluded due to lack of information. Twenty-two of these patients were in the US, 12 in Italy, nine in Japan, and four in France.
Three-quarters of the 53 patients received the full course of the drug. The patients ranged in age from 23 to 82 years, with a mean age of 64 years, and approximately three-quarters were male.
At the start of the study, 34 patients were receiving invasive ventilation, 30 were receiving mechanical ventilation, and four were receiving ECMO. The mean duration of invasive mechanical ventilation before treatment was 2 days.
The median duration of symptoms before receiving remdesivir was 12 days, and the researchers added that this did not differ between patients who received invasive and non-invasive ventilation.
While most patients showed improvement in oxygen delivery, eight patients worsened. All 12 patients breathing room air or receiving low-flow supplemental oxygen, and five of the seven patients receiving high-flow supplemental oxygen, also showed improvement.
At the last follow-up, 47% of patients had been discharged, including eight of 34 who received invasive ventilation and 17 of 19 who received non-invasive oxygenation support. However, clinical improvement was less frequent in patients who received invasive ventilation versus non-invasive ventilation, and in patients aged 70 years or older versus those under 50 years of age—generally, the patients with the worst prognosis based on currently known risk factors.
When examining safety, 32 patients reported adverse events during follow-up, the most common being elevated liver enzymes, diarrhea, rash, renal failure, and hypotension. Not surprisingly, these events were more common among patients who received invasive ventilation. Twelve patients with serious adverse events, including multiple organ dysfunction syndrome, septic shock, acute kidney injury, and hypotension, received invasive ventilation at baseline.
Four patients discontinued treatment prematurely, two due to elevated aminotransferases, one due to pre-existing renal insufficiency, and one due to multiple organ failure.
Main source
New England Journal of Medicine
Reference source: Grien J, et al “Compassionate use of Remdesivir for patients with severe Covid-19” N Engl J Med 2020; DOI: 10.1056/NEJMoa2007016.
From: https://www.medpagetoday.com/infectiousdisease/covid19/85920?xid=nl_mpt_DHE_2020-04-11&eun=g1464795d0r&utm_source=Sailthru&utm_medium=email&utm_campaign=Daily%20Headlines%20Top%20Cat%20HeC%20%202020-04-11&utm_term=NL_Daily_DHE_dual-gmail-definition