Solidarity is an international clinical trial to help find an effective treatment for COVID-19, launched by the World Health Organization and partners.
The Solidarity Trial will compare four treatment options against standard of care, to assess their relative effectiveness against COVID-19. By enrolling patients in multiple countries, the Solidarity Trial aims to rapidly discover whether any of the drugs slow disease progression or improve survival. Other drugs can be added based on emerging evidence.
Update on hydroxychloroquine
On Friday 22 May 2020, The Lancet published an observational study on hydroxychloroquine and chloroquine and its effects on COVID-19 patients that have been hospitalised. The authors reported that among patients receiving the drug, when used alone or with a macrolide, they estimated a higher mortality rate.
The Executive Group of the Solidarity Trial, representing 10 of the participating countries, subsequently met on 23 May 2020 and agreed to review a comprehensive analysis and critical appraisal of all evidence available globally.
The review will consider data collected so far in the Solidarity Trial and in particular robust randomised available data, to adequately evaluate the potential benefits and harms from hydroxychloroquine.
The Executive Group has implemented a temporary pause of the hydroxychloroquine arm within the Solidarity Trial while the safety data is reviewed by the Data Safety Monitoring Board.
The other arms of the trial are continuing. Hydroxychloroquine and chloroquine are accepted as generally safe for use in patients with autoimmune diseases or malaria.
Those patients previously randomized to hydroxychloroquine treatment will continue to receive hydroxychloroquine until they finish their course of treatment.
Participation in Solidarity
Over 400 hospitals in 35 countries are actively recruiting patients and nearly 3500 patients have been enrolled from 17 countries. Overall, over 100 countries have joined or expressed an interest in joining the trial, and WHO is actively supporting 60 of them with:
- ethical and regulatory approvals of the WHO core protocol;
- identification of hospitals participating in the trial;
- training of hospital clinicians on the web-based randomization and data system;
- shipping the trial drugs as requested by each participating country.
The greater the number of participating countries, the faster results will be generated. WHO is facilitating access to thousands of treatment courses for the trial through donations from a number of manufacturers. WHO is also inviting developers and companies to collaborate on ensuring affordability and availability of the treatment options if they prove effective.
Treatment options under study
Based on evidence from laboratory, animal and clinical studies, the following treatment options were selected: Remdesivir; Lopinavir/Ritonavir; Lopinavir/Ritonavir with Interferon beta-1a; and Hydroxychloroquine.
Remdesivir was previously tested as an Ebola treatment. It has generated promising results in animal studies for Middle East Respiratory Syndrome (MERS-CoV) and severe acute respiratory syndrome (SARS), which are also caused by coronaviruses, suggesting it may have some effect in patients with COVID-19.
Lopinavir/Ritonavir is a licensed treatment for HIV. Evidence for COVID-19, MERS and SARS is yet to show it can improve clinical outcomes or prevent infection. This trial aims to identify and confirm any benefit for COVID-19 patients. While there are indications from laboratory experiments that this combination may be effective against COVID-19, studies done so far in COVID-19 patients have been inconclusive.
Interferon beta-1a is used to treat multiple sclerosis.
Hydroxychloroquine is used to treat rheumatology conditions.*
* 25 May Update: As per the initial trial protocol, chloroquine and hydroxychloroquine had both been selected as potential drugs to be tested within the Solidarity Trial. However the trial was only ever pursued with hydroxychloroquine, so chloroquine was removed as a listed treatment option under study
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