Soo Aleman, national coordinator for WHO study: "A global study will give us better answers" - leaher
Sweden can contribute solid data to Solidarity, a global study run by the WHO to test the efficacy and safety of drugs considered for use in the treatment of COVID-19, says Soo Aleman, docent and consultant, and coordinator of the Swedisg arm of the study.
What does being a national coordinator for the Solidarity study involve?
“It involves coordinating a network of representatives from the seven university hospitals in Sweden to take part in the WHO’s global Solidarity study, which tests the efficacy and safety of a number of drugs for the treatment of COVID-19 patients,” says Soo Aleman, docent at the Department of Medicine, Huddinge, Karolinska Institutet and consultant and divisional manager at the infectious diseases unit at Karolinska University Hospital in Huddinge.
What is still not known about COVID-19 drugs and what can this study do about it?
“At present no drug has been shown to work against COVID-19. The problem is that the numerous treatment studies done have been small and without control groups, which makes it difficult to evaluate the effects of the drugs being tested. Small studies also give no reliable information about how safe these drugs are. So it’s especially important that we do large studies so that we can give patients the best and safest treatment.
“By including many patients in a global study like this, we can get better answers about the drugs’ efficacy and more reliable safety data. Solidarity’s greatest strengths is the sheer size of the patient group when the countries combine their results and the existence of a control arm – standard treatment – to compare with.”
How will the national study be done?
“We’ll start by randomly assigning patients to a remdesivir, hydroxichloroquine or standard-treatment group. We hope to include 1,000 patients. We’re collaborating with Norway and using the same study protocol as them to secure more patients and to be able to make more reliable analyses. We’ve submitted applications for the study to the Swedish Medical Products Agency and the Ethical Review Board and are currently waiting for their replies.”
What contribution can the Swedish arm of the study make?
“The Swedish researchers have good experience of clinical trials and can contribute good datasets. Since it wants the various countries to get started with the minimum of hassle, the Solidarity study is based on a very simple protocol. We’re studying more than the basic parameters in our study in the hope that it will tell us more about the disease.”
What do you hope your national efforts will achieve?
“That we’ll be able to exchange experience and knowledge in this national network. It can also be used to conduct other studies. Once we’ve got going with the Solidarity study, we plan to invite other Swedish hospitals to take part. Many have already got in touch to express their interest.”
How will the results of the study be coordinated?
“The study is adaptive, which means that the research frameworks can be adjusted as we learn more about which drugs are effective and which aren’t. A global data and safety committee will make interim analyses and decide if any of the frameworks have a demonstrable effect, if any should be stopped for not being effective or if other drugs should be brought in.”