Green light for clinical trial to study the efficacy of convalescent plasma as a treatment for COVID-19

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29/10/2020

Green light for clinical trial to study the efficacy of convalescent plasma as a treatment for COVID-19

The study, co-led by the director of IrsiCaixa Bonaventura Clotet, will evaluate the efficacy of convalescent plasma as a treatment for COVID-19 in people over the age of 50 with mild or moderate symptoms and who are not hospitalised

IrsiCaixa, together with the Fight AIDS and Infectious Diseases Foundation (FLS), the Barcelona Institute for Global Health (ISGlobal), the "Banc de Sang i Teixits", the Hospital Germans Trias, Grifols and the "Direcció d'Atenció Primària Metropolitana Nord", has started a clinical trial, the CONVERT study, with the aim of slowing down the progression of COVID-19. The study, led by Dr. Bonaventura Clotet, director of IrsiCaixa, and Dr. Oriol Mitjà, a researcher at FLS, aims to evaluate the effectiveness of treatment with convalescent plasma in people over 50 years of age with mild or moderate COVID-19 symptoms and who are not hospitalised. Convalescent plasma is a component obtained from the blood of people who have recently overcome the COVID-19. It contains antibodies against the SARS-CoV-2 virus and can therefore be used to supplement and stimulate the immune system of patients.

The aim of the study is to find out whether early treatment of the disease with this plasma can slow down its progression and reduce the severity and duration of the symptoms. This is a safe therapy previously evaluated to stop other conditions, such as the SARS-CoV-1 epidemic of 2003, the H1N1 pandemic of 2009-2010 and the MERS-CoV-2 epidemic of 2012.

 

Volunteers will have a follow-up period of two months from the start of the study

Participants in the CONVERT study, in parallel with the treatment of COVID-19 prescribed by their doctor, will receive convalescent plasma or placebo, at random. In addition, the trial will be 'double-blind'; neither the research team nor the participants will know who has received the treatment or the placebo.

The convalescent plasma and the placebo will have a similar appearance and both their administration and the follow-up of the patients will be done according to the same protocol. It reduces possible bias and gives the maximum scientific rigour to the study. From the day of administration, when the patients will also undergo a physical examination, accompanied by a blood test and a nasopharyngeal sample, they will be monitored by a doctor for approximately two months. Throughout this period of time, and at different times during the study, volunteers will have to carry out different tasks, such as taking body temperature, completing a questionnaire regarding symptoms, attending to a telephone follow-up and receiving home visits from healthcare workers.

 

Call for participation

The researchers aim to involve a minimum of 400 people with COVID-19 in the study. Aware of the scientific, logistical and organisational challenges involved in the project, they are keen to encourage citizen participation. Therefore, we encourage people aged 50 or over who have obtained a positive result from COVID-19 through a PCR test and who have had symptoms that do not require hospitalisation for at least five days to participate in the study. This is open to people assigned to the Barcelona Health Region, Metropolitana Sud Health Region and Metropolitana Nord Health Region. Those interested can register their studies through the website www.estudiconvert.orgor by email at estudicovid19@flsida.org.

Regarding convalescent plasma, researchers are counting on the collaboration of the "Banc de Sang i Teixits" to obtain it, and they are also appealing to people who have overcome COVID-19 disease more than 28 days and less than 3 months ago and who want to donate plasma. In order to donate, it is necessary to register at the following address: https://www.donarsang.gencat.cat/ca/plasma-de-malalts-convalescents-de-la-covid-19.

 

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