Clinical trials for Covid-19:
Solidarity & Discovery
On 30 March 2020, AICIB began collaborating, at the request of the Ministry of Health and Infarmed, in the implementation of two clinical trials in Portugal for the treatment of COVID-19. The clinical trials, Solidarity and Discovery, are promoted, respectively, by the World Health Organization (WHO) and the Institut National de la Santé et de la Recherche Médicale (INSERM), a French public organisation exclusively dedicated to biological, medical and public health research.
The primary goal of both trials is to gather scientific evidence on the treatment options for Covid-19 that appear most promising and whose experimental use in these patients consequently meets with greater consensus in the medical community and specialised scientific groups. However, the Discovery study protocol is based on the WHO core protocol and is a complementary and more detailed evaluation of the Solidarity Protocol, which in turn pursues the goal of extreme procedural simplicity to facilitate a globally comprehensive international collaboration in the context of a pandemic emergency.
With a view to dissemination to national hospitals, on 24 April 2020, a meeting was held on the implementation project of these clinical trials, which was attended by the Minister of Health, Dr. Marta Temido, AICIB, Infarmed and all hospital administrations of institutions with areas dedicated to Covid-19 at national level.
Solidarity is an international, adaptive clinical trial to investigate an effective treatment for COVID-19 and is sponsored by the World Health Organisation and co-promoted by national partners, in Portugal by AICIB. It is one of the largest international randomised clinical trials for COVID-19 treatments, having recruited to date almost 12,000 participants in 500 hospitals in over 30 countries.
Solidarity aims to evaluate the effect of medication on three important outcomes in patients with COVID-19: mortality, need for assisted ventilation and length of hospital stay. The clinical trial compares treatment options, in addition to and controlled by standard care therapy, to assess their relative effectiveness in relation to COVID-19.
Initially taking place only at Curry Cabral Hospital, after some protocol alterations, it included the addition of 6 new trial centres (Santo António Hospital, Vila Nova de Gaia Hospital, Guimarães Hospital, Setúbal Hospital, Douro and Vouga Hospital and Baixo Vouga- Aveiro Hospital).
On 15 October 2020, interim results from Solidarity were published, in which the 4 treatments evaluated, hydroxychloroquine, lopinavir / ritonavir, lopinavir / ritonavir plus interferon β 1a, and remdesivir were found to have little or no effect on overall mortality, ventilator onset and length of stay in hospitalised patients.
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With the spread of COVID-19 in Europe, INSERM established a multidisciplinary team to develop a multi-arm randomised controlled clinical trial called DisCoVeRy. The aim of the study is to evaluate the clinical efficacy and safety of different existing and re-used investigational drugs compared to baseline therapy in hospitalised patients with COVID-19.
The primary endpoint of the trial is clinical status at Day 15 on a 7-point ordinal scale of the WHO Core Protocol (V.3.0, March 3, 2020). This study involves patients hospitalised in conventional services or intensive care medicine units of academic or non-academic hospitals across Europe. A sample size of 3100 patients was the initial target. This clinical trial started in France on 22 March 2020.
Since 5 April 2020, DisCoVeRy has been a complementary clinical trial to the Solidarity trial, conducted by WHO in Europe and worldwide.
The sites approved to conduct the trial in Portugal were: CHU São João, CHULN Hospital. Santa Maria with the services of Internal Medicine and Medicine II, H. Beatriz Ângelo, H. Lusíadas-Cascais, CH Médio Tejo and 2CA Braga.
The trial has now recruited 1305 participants globally, including 36 in Portugal.
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