Just over a month ago, in WHO Solidarity Therapeutics Trial: Remdesivir, HCQ, Lopinar/Ritonavir & Interferon Disappoint, we looked at the disappointing results from six-months worth of clinical trials on several heavily touted treatment options for COVID-19 that found all of them had little or no effect on 28-day mortality or in-hospital course of illness.
Despite these negative findings the FDA recently approved Remdesivir as a treatment for COVID-19 in the United States, and last month the EU recently 500,000 doses of the drug.
Late last month Eli Lilly & ViralClear Halted Clinical Trials For Their COVID-19 Treatments as well, after early data suggested that the drugs being tested were not providing a benefit to hospitalized COVID patients.
And convalescent plasma therapy, which was hailed as a potential `game changer' last spring, has yet to prove its worth. Last month, in BMJ: Clinical Trial On Convalescent Plasma Showed Little Benefit For COVID-19, we looked at history of convalescent plasma, and the disappointing results in clinical trials against COVID-19, and previously against Ebola, MERS-CoV, and Influenza.
The one bright spot is dexamethasone - a corticosteroid that has proven helpful for patients in severe respiratory distress - although its use is somewhat controversial, as it has previously been linked to lower 60-day survival with severe influenza and MERS-CoV infections.
However, as study published last week (see St. Jude Research: Limited Role Of Cytokine Storm In COVID-19 Patients) suggests only a small percentage of severely ill COVID cases may actually benefit from corticosteroids.
There are other clinical trials underway, and it is possible that they will find more convincing evidence of efficacy for some of these treatments, but for now the pharmacological options for COVID-19 are distressingly few.
Lacking better options and despite their poor showing in clinical trials, many doctors continue to utilize these drugs, in hopes that they will provide some benefit to some of their patients.
Today, however, the World Health Organization has gone one step further, and is now actively recommending against the use of Remdesivir for COVID-19.
We've an announcement from the WHO, along with a link to a 41-page PDF Therapeutics and COVID-19: living guideline, and a link to a BMJ Practice Rapid Recommendations overview of these findings.
WHO recommends against the use of remdesivir in COVID-19 patients
20 November 2020
WHO has issued a conditional recommendation against the use of remdesivir in hospitalized patients, regardless of disease severity, as there is currently no evidence that remdesivir improves survival and other outcomes in these patients.
This recommendation, released on 20 November, is part of a living guideline on clinical care for COVID-19. It was developed by an international guideline development group, which includes 28 clinical care experts, 4 patient-partners and one ethicist.
The guidelines were developed in collaboration with the non-profit Magic Evidence Ecosystem Foundation (MAGIC), which provided methodologic support. The guidelines are an innovation, matching scientific standards with the speed required to respond to an ongoing pandemic.
Work on this began on 15 October when the WHO Solidarity Trial published its interim results. Data reviewed by the panel included results from this trial, as well as 3 other randomized controlled trials. In all, data from over 7000 patients across the 4 trials were considered.
The evidence suggested no important effect on mortality, need for mechanical ventilation, time to clinical improvement, and other patient-important outcomes.
The guideline development group recognized that more research is needed, especially to provide higher certainty of evidence for specific groups of patients. They supported continued enrollment in trials evaluating remdesivir.
Practice Rapid Recommendations
A living WHO guideline on drugs for covid-19
BMJ 2020; 370 doi: https://doi.org/10.1136/bmj.m3379 (Published 04 September 2020)
Cite this as: BMJ 2020;370:m3379
As much as we desperately need a magic bullet against COVID-19, pharmacological solutions - as they do for most viral illnesses - remain elusive.
