The World Health Organization’s Phase II/III SOLIDARITY trial for COVID-19 is currently the world’s largest randomized clinical trial for the treatment of COVID-19, with 11,266 patients enrolled from 405 hospitals located in more than 30 countries. The trial is designed to investigate the effectiveness of four different drugs or combinations—remdesivir, a combination of lopinavir and ritonavir, interferon beta, and chloroquine or hydroxychloroquine—compared to standard of care in subjects hospitalized with COVID-19.
Only six months after initiation, interim results were reported on October 15, 2020, that showed that the drug candidates, given by themselves or in combination, had little to no effect on the 28-day mortality or the in-hospital course. In-hospital course included initiation of ventilation and duration of the hospital stay.
One of the surprising results of this trial is that remdesivir showed little to no effect, as remdesivir is the only drug candidate within this trial currently approved for the treatment of COVID-19 and has shown positive data in previous trials. The drug candidate received FDA emergency use authorization back on May 1 and was taken recently by President Donald Trump when he was being treated at Walter Reed Medical Center for COVID-19. The results from the SOLIDARITY trial were not published in a peer-reviewed journal and unlike the previous remdesivir trial by the NIAID that found
positive results for patients, the SOLIDARITY trial did not have a placebo, nor was it double-blinded. It is also not clear how sick patients were when they were hospitalized, and because of the variation of healthcare systems in different countries, the criteria for hospitalizing patients may have differed. The SOLIDARITY trial enrolled patients from March to October and during this time the standard of care changed greatly; early on, patients were put on ventilators much faster, whereas now there are studies that have found ventilation in some cases worsens symptoms.
On the other hand, the SOLIDARITY trial did show that large-scale international trials are possible during a pandemic with the possibility of drawing conclusions at a rapid pace, as soon as six months.