A cheap, safe and widely available drug that has been used to treat malaria for at least a century has emerged as the most sought-after medicine in the world after preliminary trials from China said it boosted recovery and lowered the severity of coronavirus disease (Covid-19), which has sickened 1.2 million and killed 65,000 around the world within four months.
India on Saturday completely banned the export of hydroxychloroquine, of which it is the world’s biggest producer, even as President Donald Trump urged Prime Minister Narendra Modi to send the medicine to the United States, which has reported at least 300,000 cases and close to 8,500 deaths.
A blanket ban on the export of hydroxychloroquine and its active pharmaceutical ingredients (APIs), which are the chemicals used to manufacture the drug, will help India stockpile and ramp up production at very short notice. India has approved the use of the drug as prophylaxis to protect health workers and close contacts of Covid-19 patients from infection.
What majorly boosted the global demand for hydroxychloroquine were the results of a small placebo-controlled clinical trial in China that demonstrated the anti-malarial drug shortened the duration and reduced the severity of cough, fever and pneumonia in patients with mild and moderate disease.
Hydroxychloroquine also prevented the illness from worsening in patients given the drug, compared to the placebo group, said the study, which was published on medRxiv, which publishes studies before peer-review to expedite access to new research.
A placebo-controlled trial is done with two groups of patients, one of which is given a placebo with no drug action, while the drug is tested on another group. This method rules out bias in the outcome and ensures the drug’s effects are actually caused by the treatment and not external factors.
Since the Sars-CoV-2, the virus that causes Covid-19, is about four months old, clinicians worldwide have been depending on experimental therapies using existing drugs in different permutations and combinations to treat symptoms and stop disease progression.
Repurposing medicines with established safety and drug action on the human body is the fastest way to treat new diseases against which there is no clinically proven treatment. It allows clinicians and public health specialists to begin treatment until drugs and vaccines with specific action against Covid-19 are approved.
China, France, South Korea, Italy and now the United States are using antimalarials with some success to treat people severely ill with Covid-19 even though to a recent paper published in the Annals of Internal Medicine said “data to support the use of hydroxychloroquine and chloroquine are limited and inconclusive”. It added there was an urgent need for well-done, randomised clinical trials to test potential therapies, including hydroxychloroquine.
No drug has been approved to treat Covid-19, which leads to potentially fatal complications in about 5% of the people infected.
India has approved the combination of two antiviral drugs used to treat HIV, lopinavir and ritonavir (400 mg and 100 mg, respectively), to treat Covid-19, but the first major study of Covid-19 treatment published in the New England Journal of Medicine (NEJM) found it did not work on severely ill patients in China. “Treatment with lopinavir-ritonavir was not associated with a difference from standard care in the time to clinical improvement,” concluded the study based on randomised, controlled trial on 199 hospitalised patients in China.
Globally, there are 332 registered clinical trials, of which 188 are open for recruitment and 146 trials are preparing to recruit, found review of clinical trial registries as of March 24, published in the scientific journal, The Lancet. Most of these trials are taking place in China, South Korea, and high-income countries in Europe and North America.
In the absence of an evidence-base therapy, there is a critical need for large, multi-centric controlled clinical trials in limited-resource settings. India’s Empowered Committee on Covid-19 Response is boosting national innovation in the development of vaccine, drugs and diagnostic kits in the country. India is part of the World Health Organization’s multi-country solidarity trial to study potential treatments for Covid-19 to be conducted in Asia, South Africa, Europe, and the Americas. A Covid-19 Therapeutics Accelerator was launched on Friday to bring together global multidisciplinary expertise and clinical trial capacity to accelerate multicentre trials of the safety, efficacy, and effectiveness of drugs and vaccines.
But until we have a specific drug, therapy or vaccine against Covid-19, drugs like hydroxychloroquine are the best bets to treat and protect patients.
