As medical practitioners brace for a surge in number of COVID-19 patients, all eyes are on the outcomes of various drug trials conducted across the globe. From global organisations like the World Health Organisation (WHO) to individual companies and research firms, all are busy trying to find answers. Research is underway on multiple fronts but largely focussed around how some of the existing therapies for ailments like malaria, HIV, arthritis can be repurposed to deal with COVID-19.
At one end, there is work on repurposed anti-HIV medicines and at the other, repurposed antimalarial drugs like choroquine (hydroxychloroquine) along with some antibiotics like Azithromycin are being advocated. In fact, there have been many reports of US President Donald Trump referring to these as possible treatments. However, their efficacy is unproven.
Dr Soumya Swaminathan, chief scientist at the World Health Organisation (WHO) and former director general of the Indian Council for Medical Research (ICMR), spoke about WHO's effort on clinical trials called the 'Solidarity Project'. She said that "the trial will test choroquine, lopinavir/ritonavir with and without interferon beta, remdesivir versus standard of care in many countries around the world, in order to generate robust evidence on mortality and hospitalisation of the COVID-19 patients." Describing the Solidarity Protocol as "an adaptive clinical trial wherein more arms can be added later," she said that "a global data safety monitoring committee and steering committee (of international experts) will oversee the trial."
She thanked companies that have come forward to donate drugs for this purpose. She said: "We are grateful to the companies who have agreed to donate drugs for this trial - Gilead, Merck, Cipla, Mylan and AbbVie." Cipla appears to be the only Indian company contributing in this effort. She added, "as of now, there is no specific anti-COVID-19 compound that has a proven efficacy." She refers to the many in vitro studies, patient case series and others but says, there are "none that clearly establish efficacy and safety of any of the proposed drugs." High-quality research is the need of the hour, she insists.
Basel-headquartered pharma giant Roche has also announced that it is initiating phase III clinical trial of its arthritis drug Actemra in hospitalised patients with severe COVID-19 pneumonia. A note put out by the company says, it is "working with the Food & Drug Administration (FDA) to initiate a randomised, double-blind, placebo-controlled Phase III clinical trial in collaboration with the Biomedical Advanced Research and Development Authority (BARDA), a part of the US Health and Human Services Office of the Assistant Secretary for Preparedness and Response (ASPR), to evaluate the safety and efficacy of Actemra/RoActemra (tocilizumab) in hospitalised adult patients with severe COVID-19 pneumonia.
Speaking to Business Today, Y K Hamied, Chairman of Cipla, said that his company was happy to provide any of the medicines required for the trial under the solidarity project. He, like others, is keeping his fingers crossed on outcome of the trials. He said the Solidarity Project was important as trials are critical to know the efficacy of various drugs to treat coronavirus. His company manufactures the anti-HIV drugs in India and is the distributor in India for Roche's arthritis medicine.