Solidarity trial
The Solidarity trial for treatments is a multinational Phase III-IV clinical trial organized by the World Health Organization (WHO) and partners to compare four untested treatments for hospitalized people with severe COVID-19 illness.[1][2] The trial was announced 18 March 2020,[1] and as of 6 August 2021, 12,000 patients in 30 countries had been recruited to participate in the trial.[3]
For other clinical trials on drug candidates for treating COVID-19 disease, see COVID-19 drug development.
In May, the WHO announced an international coalition for simultaneously developing several candidate vaccines to prevent COVID-19 disease, calling this effort the Solidarity trial for vaccines.[4]
The treatments being investigated are remdesivir, lopinavir/ritonavir combined, lopinavir/ritonavir combined with interferon-beta, and hydroxychloroquine or chloroquine. Hydroxychloroquine or chloroquine investigation was discontinued in June 2020 due to concluding that it provided no benefit.
The individual or combined drugs being studied in the Solidarity and Discovery projects are already approved for other diseases.[2] They are:[2][7]
Due to safety concerns and evidence of heart arrhythmias leading to higher death rates, the WHO suspended the hydroxychloroquine arm of the Solidarity trial in late May 2020,[14][15] then reinstated it,[16] then withdrew it again when an interim analysis in June showed that hydroxychloroquine provided no benefit to hospitalized people severely infected with COVID-19.[13]
In October 2020, the World Health Organization Solidarity trial produced an interim report concluding that its "remdesivir, hydroxychloroquine, lopinavir and interferon regimens appeared to have little or no effect on hospitalized COVID-19, as indicated by overall mortality, initiation of ventilation and duration of hospital stay."[17] Gilead – the manufacturer of remdesivir – criticized the Solidarity trial methodology after it showed no benefit of the treatments, claiming that the international nature of the Solidarity trial was a weakness, whereas many experts regard the multinational study as a strength.[18] Purchase agreements between the EU and Gilead for remdesivir and granting of its Emergency Use Authorization by the US FDA during October were questioned by Solidarity trial scientists as not based on positive clinical trial data, when the interim analysis of the Solidarity trial had found remdesivir to be ineffective.[18]
In January 2022, the Canadian component of the Solidarity trial reported that in-hospital people with COVID-19 treated with remdesivir had lower death rates (by about 4%) and reduced need for oxygen (less by 5%) and mechanical ventilation (less by 7%) compared to people receiving standard-of-care treatments.[19]
Support and participation[edit]
During March, funding for the Solidarity trial reached US$108 million from 203,000 individual donations, charitable organizations and governments, with 45 countries involved in financing or trial management.[1][20] As of 1 July 2020, nearly 5,500 patients in 21 countries of 39 that have approval to recruit were recruited to participate in the trial. More than 100 countries in all 6 WHO regions have expressed interest in participating.[3]
Solidarity Plus Trial[edit]
The WHO announced in August 2021 that it will roll out the next phase Solidarity trial under the name Solidarity PLUS trial in 52 countries. The trial will enroll hospitalized patients to test three new drugs for potential treatment of COVID-19. These drugs include artesunate, imatinib and infliximab. The selection of these therapies was done by an independent expert panel of WHO. These drugs are already used for other indications: artesunate is used for malaria, imatinib for cancers, and infliximab, an anti-TNF agent is used for Crohn's Disease and rheumatoid arthritis. The drugs will be donated for the purpose of trial by their manufacturers.