The SOLIDARITY trial, conceived of by the World Health Organization and sponsored by Oslo University Hospital in Norway, enrolled its first patient in this important study comparing the safety and effectiveness of four therapy combinations against COVID-19, reported Bent Høie, Norway’s Health Minister of health and care services at a World Health Organization media briefing Friday. The first patient was someone at the Oslo University Hospital. TrialSite News has been inundated with requests for more information and the research team does its best to help those seeking more information. WHO should immediately share more details about who is participating (e.g. country/site/hospital) and about how to participate in this study.

The Study

The SOLIDARITY trial is a multi-center, adaptive, randomized, open clinical trial to evaluate the safety and efficacy of hydroxychloroquine, remdesivir and standard of care in hospitalized patients diagnosed with COVID-19. The trial will follow core WHO protocol but has additional efficacy, safety and explorative endpoints.

The trial started on March 26, 2020 and will run through November 2020. The sponsors seek up to 700 participants.  Although there are reports of up to 45 counties involved in the official U.S. Clinicaltrials.gov listing only Norwegian investigators are included—contacts will be provided at end of this article.

The regimen includes three arms including 1) active comparator of Hydroxychloroquine compared  to Remdesivir which will be given intravenously 100 mg daily for the duration of the hospitalization up to a in 9 days to 10 days in total course. A loading dose of 200mg at inclusion will be given; additionally in this arm includes Standard of Care which will be supplied to all patients not receiving a drug intervention; then the second arm 2) is active compactor of Remdesivir compared to Hydroxychloroquine administered orally (in the ICU in the gastrointestinal tubes) with 600 mg x2 loading dose followed by 200 mg x3 every day for 10 days. Also in this arm a standard of care to all patients not receiving drug intervention; and finally a third arm 3) of comparator group of Control Group on standard of care against two intervention groups including one A) on Hydroxychloroquine—orally (in the ICU in gastrointestinal tubes) with 600 mg x2 loading dose followed by 200 mg x3 for every 10 days—and B) Remdesivir—given intravenously 100 mg daily for the duration of the hospitalization up to a in 9 days 10 days total course. A loading dose of 200 mg at inclusion will be administered.

Other Countries Participating

As mentioned, the names of the other sites are not included in Clinicaltrials.gov. Only Oslo University Hospital is listed but there are reports from WHO’s Director- General that up to 45 other countries are participating. According to World Health Organization (WHO) Director-General Tedros Adhanom Ghebreyesus, by March 18, ten countries had already signed on to take part in the clinical trial reported STAT. These countries included Argentina, Bahrain, Canada, France, Iran, Norway, South Africa, Spain, Switzerland and Thailand. The first patients were to be enrolled in Spain and Norway

Additionally, a search of the press finds that India appears to be joining soon according to a recent Times of India article where Raman R. Gangakhedkar, Head of Epidemiology and Communicable disease at India’s ICMR, noted, “We are soon likely to participate in the WHO Solidarity trial.”

Solidarity Trial WHO Contact

Ana Maria Henao-Restrepo heads WHO’s research and development “blueprint” group and reported that the SOLIDARITY trial was designed to be simple “to enable even hospitals that have been overloaded to participate” as reported by Helen Branswell with STAT. See the “Research and Development Blueprint” developed by WHO and mentioned in the STAT article.

WHO Solidarity Response Fund

In parallel, the World Health Organization launched the Solidarity response fund to raise money for a wide range of donors to support the work of WHO and partners to help countries respond to the COVID-19 pandemic. They purport to be the first of its kind, enabling private individuals, corporations and institutions to organize and directly contribute to global response efforts. This fund has been created by the United Nations Foundation and the Swiss Philanthropy Foundation alongside WHO. More about the fund can be found here

WHO Needs to Share more Information about its Clinical Trial

WHO needs to be a little more transparent with the SOLIDARITY trial. For example, it names 10 counters that are participating but it fails to name contacts, authorities or research sites or hospitals. A base level of transparency and openness to  sharing data and knowledge, as TrialSite News discussed with the Taiwan success story, represents a model to consider.

Lead Research/Contacts

At Oslo University Hospital

Paul Aukrust, MD, Professor:  0047 467 778374 and email paukrust@ous-hf.no

Andreas Barratt-Due, MD:  0047 98209974 and email andreas.barrattdue@gmail.com

At WHO

Ana Maria Henao-Restrepo

Call to Action: See contacts above and check with your local health authority to see if they are in discussions with your national government to join this study. Also check the WHO website as they do provide information but it is not nearly as consolidated and easy to access as we would like. Keep your questions coming to TrialSite News. We will do our best to get them answered.

Source: ClinicalTrials.gov

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