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solidarity trial

What is the WHO ‘Solidarity’ Trial for Covid-19?

The World Health Organization (WHO) said Monday that due to safety concerns, it is temporarily halting a clinical trial of the anti-malaria drug hydroxychloroquine for treating coronavirus patients.

About “Solidarity” Trial:

“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.

Rationale

The pressure COVID-19 puts on health systems means that WHO considered the need for speed and scale in the trial. While randomized clinical trials normally take years to design and conduct, the Solidarity Trial will reduce the time taken by 80%.

Enrolling patients in one single randomized trial will help facilitate the rapid worldwide comparison of unproven treatments. This will overcome the risk of multiple small trials not generating the strong evidence needed to determine the relative effectiveness of potential treatments. 

Participation in Solidarity Trial

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

India is among the countries where the Solidarity Trial is being carried out. Four hospitals in Jodhpur, Ahmedabad, Chennai and Bhopal have received regulatory approvals, and more will follow. In all, patients in 20-35 hospitals in the country will be part of the trial.

Treatment options under study in Solidarity Trial

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.

Remdesivir is a broad-spectrum antiviral medication developed by the biopharmaceutical company Gilead Sciences. As of 2020, remdesivir is being tested as a specific treatment for COVID-19, and has been authorized for emergency use in the U.S. and approved for use in Japan for people with severe symptoms

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.It is produced by mammalian cells, while interferon beta-1b is produced in modified E. coli.nterferon beta balances the expression of pro- and anti-inflammatory agents in the brain, and reduces the number of inflammatory cells that cross the blood brain barrier

Hydroxychloroquine is used to treat rheumatology conditions.*

 

The World Health Organization (WHO) said Monday that due to safety concerns, it is temporarily halting a clinical trial of the anti-malaria drug hydroxychloroquine for treating coronavirus patients.

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