Coronavirus Disease-2019 (COVID-19) pandemic has resulted in an emergence of medical studies to combat the effects of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), the virus that causes COVID-19. Such therapies currently being applied range from vaccines to repurposed treatments for influenza, to drugs that were not effective in patients with Ebola, to malaria treatments that were formulated years ago.
In line with this, the World Health Organization (WHO) conducted a comprehensive analysis of the rationale for the various therapeutics currently in use. With the Solidarity Clinical Trial, the WHO is using its capacity to promote global cooperation and study to test a variety of alternative treatment solutions, ensure that patients have access to safe and appropriate drugs and eventually save lives.
Based on evidence from laboratory, animal, and clinical studies, the following treatment options were selected: Remdesivir; Lopinavir/Ritonavir; Lopinavir/Ritonavir with Interferon beta-1a; and Chloroquine or Hydroxychloroquine. Furthermore, Remdesivir was previously tested as an Ebola treatment. It has generated promising results in animal studies for Middle East Respiratory Syndrome (MERS-CoV) and SARS, which are also caused by coronaviruses, suggesting it may have some effect in patients with COVID-19.
On the other hand, Lopinavir/Ritonavir is a licensed treatment for HIV. Evidence for COVID-19, MERS, and SARS has yet to show if it can improve clinical outcomes or prevent infection. This trial aims to identify and confirm any benefit for COVID-19 patients. While there are indications from laboratory experiments that this combination may be effective against COVID-19, studies done so far in COVID-19 patients have been inconclusive. The Interferon beta-1a is used to treat multiple sclerosis, while the Chloroquine and Hydroxychloroquine are very carefully related and used to treat malaria and rheumatology conditions.
In China and France, small studies provided some indications of the possible benefit of chloroquine phosphate against pneumonia caused by COVID-19, but still needed some confirmation through randomized trials. All these experiments belong to the ‘multivariate’ statistical test as it investigates the relationship between the patient’s health, the age, and the days to recover.
As a community, we should not disregard the WHO’s invitation to enroll patients in one single randomized trial, as it will help facilitate the rapid worldwide comparison of unproven treatments. This will overcome the risk of multiple small trials, not generating the strong evidence needed to determine the relative effectiveness of potential treatments. The higher the number of participating countries, the faster results will be generated.
There is only one way the world can egress this pandemic – and that is through science. We need diagnostics to detect and limit the spread of this virus, vaccines to provide long-term protection while temporary treatments will still be given to patients to save lives in the shorter-term. Solidarity will also use an adaptive design, which will allow for the discontinuation of drugs that lack effectiveness and add new drugs that appear promising. This type of trial design offers flexibility and efficiency, particularly in identifying early signals related to either efficacy or toxicity while maintaining study validity.