A top global priority is to find agents that can stop the severe course of COVID-19 infection and consequently increase the chances of patient survival as rapidly as possible. Specific tests have shown that there are some promising drugs available, which have efficacy against the new coronavirus and have already been approved for the treatment of other diseases such as HIV and malaria. The World Health Organisation (WHO) has selected four particularly promising agents or agent combos for testing in a clinical trial programme that is being conducted across several countries. The DZIF and DZL have assumed the role of coordinating this Solidarity Trial in Germany. The trial is being supported by all German Centres for Health Research (DZG) and is being funded by the BMBF (Federal Ministry of Education and Research).
The Federal Minister of Education and Research, Anja Karliczek, explains: “I am very grateful to the WHO for this important initiative. The corona pandemic is a global challenge. We therefore also need global action. The Solidarity Trial will enable us to improve our knowledge about the effects of known drugs and jointly improve the collection of scientific data on a global scale. I also give particular thanks to the researchers in Germany who are actively involved in the trial. They are making a great contribution towards our society.”
“We are proud to be able to co-lead this WHO megatrial in Germany,” explains Hans-Georg Kräusslich, Chair Executive Board of the German Center for Infection Research (DZIF), who is himself a virologist. “We urgently need antiviral drugs for immediate use in this crisis. However,” emphasizes Kräusslich, “they do still need to be tested for efficacy and safety in large clinical trials and the best ones subsequently approved for large-scale treatment.” Werner Seeger, Chair Executive Board of the German Lung Research Center (DZL), adds: "It is understandable that colleagues in China, under the clinical pressure of the initial outbreak, have applied many possible therapeutic approaches – often in parallel – but for reliable statements on the suitability of these drug approaches we need controlled clinical studies, such as the WHO Solidarity Trial, which is just now underway. It cannot be excluded that one or more of the drugs might have adverse effects on the clinical course of the disease."
The WHO Solidarity Trial
SOLIDARITY is the very first attempt being carried out by the WHO for the collection of robust scientific clinical data on a global scale during an ongoing pandemic and within extreme time pressures. Thousands of patients from different countries are being administered with the drugs in the same controlled manner. The megatrial is designed in such a way so as to allow hospitals currently overwhelmed by an influx of patients to participate and to contribute towards the collection of data. After patients have given their informed consent, they are reported to the WHO, who subsequently assigns them to a specific form of treatment. The physicians then report back on the date at which the patient was either discharged from hospital or died and whether the patient required oxygen or ventilation.
Which drugs and combos are being tested?
The WHO has selected four specific treatments which seem to be the most promising and the safest according to data from previous use. These four treatments include:
Firstly, remdesivir, an antiviral agent originally developed to treat Ebola which but which demonstrated insufficient efficacy against Ebola. However, it has been shown to be effective against coronaviruses in animal tests. Secondly, chloroquine (only used outside of Europe) and hydroxychloroquine, malaria agents which have shown in-vitro efficacy against SARS-CoV-2. Thirdly, a combination of two HIV drugs known as lopinavir and ritonavir and finally, a combination of these two HIV agents and interferon beta, an immune system messenger substance which stimulates cellular immune responses against viral infections.
Prof. Susanne Herold
University Hospital of Giessen
T +49 641 985 57061
Prof. Tobias Welte
Hannover Medical School
T +49 511 532 3530