Amid the political debate, the US NIH has last week begun the clinical trials of the malarial drug hydroxychloroquine to test its efficacy and safety in patients with COVID-19.

What is hydroxychloroquine? 

Hydroxychloroquine (HCQ) (aka hydroxychloroquine sulfate), is a drug available in the market to treat a range of disorders including Malaria, and Autoimmune disorders such as lupus and rheumatoid arthritis. Belonging to a class of drugs known as disease-modifying antirheumatic drugs (DMARDs), Hydroxychloroquine has the potential to reduce skin problems in lupus and prevent swelling/pain in arthritis. 

Available only by prescription, it is sold under the brand name Plaquenil and is available as a generic medicine as well. 

For how long Hydroxychloroquine has been in the market? 

Hydroxychloroquine got recommended to be used against malaria in 1955 and is categorized as the safest and most effective medicines needed in a health system.

The drug was used by the US to protect its army during World war II in south-east Asian countries, where malaria was one of the most prevalent diseases. 

The drug; however; is approved for indications including uncomplicated malaria due to Plasmodium falciparum, P. malariae, P. ovale, and P. vivax; chronic discoid lupus erythematosus and systemic lupus erythematosus in adults; and acute and chronic rheumatoid arthritis in adult. 

India emerges as the biggest exporter of Hydroxychloroquine

India is one of the largest markets for generic drugs. The drugs whose patent expires, India manufacture and export them at much cheaper rates. The drug – Hydroxychloroquine – falls under the same category. 

Approved for other diseases, the demand for the drug rose dramatically after it was named as one of the possible effective treatment for COVID-19. As the cases are soaring high, the Indian government banned the export, however, recently the country has cleared the shipment of Hydroxychloroquine to 13 countries including US, Spain, Germany, Bahrain, Brazil, Nepal, Bhutan, Afghanistan and many others, assuring the world of easy availability of the drug in the country. Moreover, the Indian health ministry has informed that India possesses a current stock of over 3.28 crore Hydroxychloroquine tablets clarifying the apprehensions. 

In addition to Hydroxychloroquine, India is also exporting tonnes of paracetamols to countries on first come first basis. 

Hydroxychloroquine, COVID-19, and Clinical trials 

Dozens of clinical studies are ongoing to study the efficacy and safety of the drug in fighting COVID-19. Hydroxychloroquine and chloroquine are under clinical evaluations for pre-exposure or post-exposure prophylaxis of SARS-CoV-2 infection, & treatment of adult patients with mild, moderate, and severe COVID-19.

A clinical trial – ORCHID Study for the same is underway by the Prevention and Early Treatment of Acute Lung Injury (PETAL) Clinical Trials Network of the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health. The study is analyzing the outcomes of the symptomatic COVID-19 patients administered with hydroxychloroquine. 

Earlier trials have shown that the drug might have the potential to block out the novel coronavirus – SARS-CoV-2, from infecting animal cells. The study hinted towards the antiviral activity of the drug; however, not sufficient to be used in humans. 

There is no such evidence that HCQ would help in winning the battle against SARS-CoV-2 by preventing it. Hence, it is still debatable that the drug has helped in improving the course of the disease by lowering down the levels of virus in the human body. 

However, on March 28, 2020, the US FDA has given the Emergency Use Authorization (EAU) to the drug for its use in adolescent and adult patients with COVID-19. But there the doctors and physicians are sceptical in prescribing the medication outlining potential health risks, including heart rhythms.  

The drug itself carries the warning and risks of side effects it can cause with the possibility of blindness due to retinal injury, unconsciousness due to low blood sugar, suicidal behavior, heart failure, potentially lethal interactions with other drugs, lethal heart rhythm disturbances and yes, death. Doctors are worried that with some benefit, the drug can also result in tragic side effects. 

Pandemic and the Hydroxychloroquine hype

Pandemics and viral outbreaks result in a tragic loss of lives at a pace, which is way too fast for the Healthcare industry to win out. At such crucial times, many times, physicians prescribe unapproved drugs for monitoring the efficacy and possible side effects. For such cases, the FDA has although approved the use of HCQ in COVID-19 patients not eligible for clinical trials under EUA; however, it should not be missed that the drug is still not approved. 

The use of drugs has risen the heated debate between the US government and leading healthcare experts; however, the US NIH is closely monitoring the trials undergoing, whose results will take a minimum of a month to be declared. 

Until then, the drug has the nod to be administered to confirmed COVI-19 patients, and as a preventive medicine to healthcare workers and contacts of confirmed cases.