Good news: The World Health Organization (WHO) said that the largest randomized controlled trial testing repurposed drugs for COVID-19 has yielded findings in only six months.
Bad news: They don’t work.
Interim results from the Solidarity Therapeutics Trial coordinated by the WHO indicate that remdesivir, hydroxychloroquine, lopinavir/ritonavir and interferon regimens apparently “have little or no effect” on 28-day mortality or the in-hospital course of COVID-19 among hospitalized patients.
The study covering more than 30 countries examined effects of the treatments on overall mortality, start of ventilation, and duration of hospital stay in hospitalized patients. Other uses of the drugs, such as for patients in the community or for prevention, may be tested in other trials.
In 405 hospitals, 11,266 adults were randomized, with 2,750 allocated remdesivir, 954 hydroxychloroquine, 1,411 lopinavir/ritonavir, 651 interferon plus lopinavir, 1,412 only interferon, and 4,088 no study drug. Compliance was 94% to 96% midway through treatment, with 2% to 6% crossover. In all, 1,253 deaths were reported (at median day eight, interquartile range 4-14). Kaplan-Meier 28-day mortality turned up at 12% (39% if already ventilated at randomization, 10% otherwise).
The regimens proved unworthy “as indicated by overall mortality, initiation of ventilation and duration of hospital stay,” Solidarity researchers concluded. “The mortality findings contain most of the randomized evidence on remdesivir and interferon, and are consistent with meta-analyses of mortality in all major trials.”
Though the outcomes aren’t what many wished, Solidarity’s brisk progress proves that large-scale, international studies can be carried out even as the pandemic rages, so that the medical community need not wait long for much-needed answers. With almost 500 hospitals open as sites, the global platform established by Solidarity is ready to test other would-be COVID-19 prospects. The more recently developed antiviral drugs, immunomodulators and anti-SARS COV-2 monoclonal antibodies are undergoing investigation, the WHO said.
Results from Solidarity gained thus far are under review for publication in a medical journal.
Meanwhile, among the first companies to respond to the news was Turku, Finland-based Faron Pharmaceuticals Oy. CEO Markku Jalkanen said that the findings “support our long-held view that interferon beta-1a is likely to be ineffective when given subcutaneously. The science behind [Faron’s] Traumakine and its potential to prevent multi-organ failure through the upregulation of the key endothelial enzyme CD73 is compelling, and we continue to believe that an intravenous formulation of interferon beta-1a is what patients need to strengthen the body's own interferon beta signaling,” and thereby “provide optimal exposure to the lung vasculature.”