Solidarity is an international clinical trial to evaluate the effect of a number of drugs for the treatment of COVID-19
Provisional results:
The trial results indicate that treatment regimens with remdesivir, hydroxychloroquine, lopinavir/ritonavir and interferon appear to have little or no effect on 28-day mortality or hospital outcome in COVID-19 patients.
Description of the Study:
- Title: Solidarity.
- Principal Investigators: WHO Solidarity Trial Consortium, Hongchao Pan, Richard Peto, Quarraisha Abdool Karim, Marissa Alejandria, Ana Maria Henao-Restrepo, César Hernández García, Marie Paule Kieny, Reza Malekzadeh, Srinivas Murthy, Marie-Pierre Preziosi, Srinath Reddy, Mirta Roses Periago, Vasee Sathiyamoorthy, John-Arne Røttingen and Soumya Swaminathan.
- Countries of Implementation: The trial has been conducted in 30 of the 43 countries that are authorised to begin pre-screening participants. In total, 116 countries in all six WHO regions have joined the trial or expressed interest in participating.
- Study Population: As of 2 October 2020, more than 12,000 patients were enrolled in 500 participating hospitals worldwide. Patients are required to have COVID-19, be hospitalised, have agreed to participate in the trial, and meet the trial inclusion and exclusion criteria.
- Study Type: Randomised clinical trial.
- Design: Patients were randomly assigned equally to one of the trial drug regimens and the open control, so that there were up to five treatment options: four active and the local standard of care.
- Methods: The ITT (intention-to-treat) primary analyses examined in-hospital mortality in the four pairwise comparisons of each trial drug and its control (drug available and patient assigned to the same care without that drug). Rate ratios for death were calculated with stratification according to age and status regarding mechanical ventilation at trial entry.
Objectives of the Study:
Principal Objective: To assess the effect of drugs on three important outcomes in COVID-19 patients: mortality, need for ventilator support and duration of hospitalisation.
More about this Study:
Scientific Context: The new disease caused by a new coronavirus was first described in 2019 in China and is designated COVID-19 or COVID and the pathogen (an RNA virus) is designated SARS-coronavirus-2 (SARS-CoV-2). As of early 2020, there were no approved antiviral treatments available for COVID-19, so the WHO expert group recommended evaluating four existing treatments, Remdesivir, Lopinavir (given with Ritonavir, to alleviate liver degradation), Interferon Beta1a and Chloroquine or Hydrocholroquine through an international randomised trial to provide evidence-based data on them.
Added Value: This is one of the largest international randomised trials of COVID-19 treatments, involving nearly 12,000 patients in 500 hospitals in more than 30 countries.
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