Compassionate Use of Remdesivir for Patients with Severe Covid-19 - NEJM
By: Grein, et al.
Aim: Describe outcomes in a cohort of patients hospitalized for severe Covid-19 who were treated with remdesivir on a compassionate-use basis.
- This study suggests clinical benefits of remdesivir antiviral therapy for severely ill covid-19 patients. Results are however indefinite given the lack of a placebo controlled group.
- Proven effective therapy is absent. Current management consists of: supportive care, oxygen support, treatment with antibiotics. Many patients receive off-label compassionate-use therapy.
- Remdesivir inhibits viral RNA polymerase and has broad-spectrum activity against serval viral families.m
- Included patients: rtPCR proven covid19 patients in need for oxygen support, with proper kidney and liver function in whom the clinician requested for remdesivir use.
- Treatment: 10-day course, first day 200mg IV other 9 days 100mg daily.
- 53 patients included from the US, Japan, Italy, Austria, France, Germany, the Netherlands, Spain, and Canada.
- 75% was male
- Median age 64 years
- 64% was receiving mechanical ventilation at baseline.
- 12 days from symptom onset to start remdesivir
- After median 18 days after start of remdesivir 68% of patients showed improvement in the need for oxygen support. 15% showed worsening.
- 47% had been discharged at study closure.
- Clinical improvement less frequent in patients receiving invasive ventilation and in elderly (> 70 years)
- 13% of patients died in the current study.
- 60% of patients reported adverse events of remdesivir during follow-up. The most common adverse events were increased hepatic enzymes, diarrhea, rash, renal impairment, and hypotension. 23% had serious adverse events — multiple-organ-dysfunction syndrome, septic shock, acute kidney injury, and hypotension —
- Four patients (8%) discontinued remdesivir treatment prematurely: one because of worsening of preexisting renal failure, one because of multiple organ failure, and two because of elevated aminotransferases, including one patient with a maculopapular rash.
- Although RCT’s preclude definitive conclusions, comparisons with contemporaneous cohorts from literature, in whom general care is expected to be consistent with that of the current cohort, suggest that remdesivir may have clinical benefit in patients with severe Covid-19.