Gilead drug remdesivir improves 68% COVID-19 patients: Study

Treatment with Gilead Sciences’s experimental drug remdesivir led to clinical improvement in 68 per cent of 53 patients hospitalised with severe complications of COVID-19, says a study.

The drug was provided on an individual compassionate usebasis.

   

Nearly two thirds of patients in this cohort were on mechanicalventilation at baseline, including four patients also on extracorporealmembrane oxygenation (ECMO).

Treatment with remdesivir resulted in an improvement inoxygen support class for 36 of patients over a median follow-up of 18 days fromthe first dose of remdesivir, according to the findings published in The NewEngland Journal of Medicine.

More than half of patients on mechanical ventilation wereextubated and nearly half of all patients were discharged from the hospitalfollowing treatment with remdesivir.

After 28 days of follow-up, the cumulative incidence ofclinical improvement, defined as discharge from the hospital and/or at least atwo-point improvement from baseline on a predefined six-point scale, was 84 percent.

“Currently there is no proven treatment for COVID-19.We cannot draw definitive conclusions from these data, but the observationsfrom this group of hospitalized patients who received remdesivir arehopeful,” said Jonathan D. Grein, Director of Hospital Epidemiology,Cedars-Sinai Medical Center, Los Angeles, and lead author of the journalarticle.

“We look forward to the results of controlled clinicaltrials to potentially validate these findings,” Grein said.

According to the report, 7 patents died.

Factors associated with an increased risk of mortalityincluded age greater than 70 years and higher baseline serum creatinine levels,indicating reduced kidney function.

Mild to moderate liver enzyme elevations were observed inthis cohort. No new safety signals were detected during short-term remdesivirtherapy, said the study.

Gilead is conducting two Phase 3 clinical trials ofremdesivir, the SIMPLE studies, in countries with high prevalence of COVID-19.

Data from the SIMPLE study in patients with severe diseaseare expected this month, followed by data from the SIMPLE study in patientswith moderate disease in May.

In addition, the California-based biotechnology company issupporting multiple clinical trials led by other organisations, including twostudies conducted in Hubei Province, China.

Since January 25, 2020, the company has been providingemergency access to remdesivir for qualifying patients with severecomplications of COVID-19 who are unable to enroll in ongoing clinical trials.

More than 1,800 patients have been treated with remdesivirthrough individual compassionate use protocols.Remdesivir is not yetlicensed or approved anywhere globally and has not been demonstrated to be safeor effective for the treatment of COVID-19.

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