Existing affordable drugs could rapidly reduce COVID-19 cases and deaths in India
Times of India - The COVID-19 humanitarian calamity unfolding in India is on a scale not seen in this pandemic. This is an extraordinary situation – and it may benefit from an extraordinary response.
There exist affordable, readily available and minimally toxic drugs approved for non-COVID-19 use which show remarkable promise in preventing or treating the new coronavirus. Deploying these drugs in India is likely to rapidly reduce the number of COVID-19 patients, reduce the number requiring hospitalization, supplemental oxygen and intensive care and improve outcomes in hospitalized patients.
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| Credit: American Association of Physicians and Surgeons |
Some of these drugs are being tested in large-scale randomized clinical trials in the US and abroad but in most cases, definitive efficacy data is pending. With the current COVID-19 situation in India, we do not have time to wait for results of these studies. Importantly, currently available safety and outcomes data on these drugs is strong enough that it is time to incorporate them into national practice guidelines. Indian authorities should issue such guidelines on the most promising drugs for each stage of COVID-19. By so doing, physicians will be encouraged to use these interventions. The resulting real world data from a few healthcare settings in select cities should be tracked in real time and guidelines suitably revised. If such measures were adopted, we could see effects in 3-4 weeks. This strategy might be unusual but it is not unheard of: France has the Temporary Recommendation for Use, a “regulatory instrument which aims to allow, on a temporary basis, the use of a medicinal product to allow its effectiveness to be evaluated on the basis of its use.”
The choice of drugs is critical. We have worked closely with personnel at the Food and Drug Administration and have connected with the World Health Organization and the National Institutes of Health to evaluate the merits of repurposed drugs. Based on a mechanistic rationale, data in animal models, human retrospective analyses, clinical trials (some randomized, others not) and anecdotal human data, we created a prioritized list of interventions that hold the greatest promise and that could be deployed at scale. For instance, there is strong data from a randomized trial and a real-world study that administering fluvoxamine sharply reduces the need for hospitalization in COVID-19 outpatients. Moreover, anecdotal unpublished data in over 400 acutely ill COVID-19 patients from several community practitioners suggests that administering fluvoxamine and ivermectin together may be even more efficacious.
Intervention as early as possible after symptom onset is key. Ivermectin is already listed as a “MAY DO” on the ICMR and Indian government guidelines for treatment of acute mild COVID-19 and we suggest that fluvoxamine be added in this category. Also, ivermectin in the prophylactic setting merits serious consideration. For the hospitalized, there are treatments currently used for other conditions that might reduce the need for ventilator support and lower the risk of death. These include inhaled adenosine, cyproheptadine and dipyridamole. For ideas for which there is rather limited human data, the government should offer pre-approved pilot protocols and funding for rapid implementation in select centers rather than issue a recommendation for use.
To be clear, it would be ideal to pursue large clinical trials to test the efficacy of all promising interventions. A randomized adaptive design could efficiently sift through the many possibilities. It may be possible to rapidly set up parallel protocols in India if government authorities can expedite the regulatory process and offer funding. US trial investigators can be persuaded to provide protocols and web-based data collection tools.
We hope that the Indian government will take advantage of repurposed drug research and use temporary use authorizations or guidelines to rapidly promote the most promising therapies at a national level while in parallel aggressively encourage pilot studies and large-scale clinical trials with shovel-ready protocols and funding. Given the current situation, India has little to lose in piloting these approaches: the potential gains could benefit not just the country but the world.
The views presented here reflect those of the authors and are not necessarily those of the institutions to which they are affiliated.
Authors:
Vikas P. Sukhatme MD, ScD, is the Robert W. Woodruff Professor of Medicine, Dean of Emory University School of Medicine, and Chief Academic Officer of Emory Healthcare. He is the founding director of the Emory-based Morningside Center for Innovative and Affordable Medicine. You can reach him at vsukhatme@emory.eduVidula Sukhatme, MS, is an adjunct instructor at Emory University’s Rollins School of Public Health and is the founding CEO of GlobalCures, a non-profit that aims to promote promising therapies for cancer not being pursued for lack of profitability. Her contact is vidula@global-cures.org
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