The U.S. Food and Drug Administration (FDA) this week provided the necessary authorization for clinical trials of chloroquine and hydroxychloroquine for the treatment of the novel coronavirus. These two drugs have been claimed by President Donald Trump to be a potential treatment for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, which causes COVID-19 disease. To date, there has been no conclusive proof regarding the safety and efficacy of these drugs in COVID-19 cases, say officials.
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What is the risk?
President Donald Trump, a few days back, had claimed to the media that the FDA had approved the drug for coronavirus treatment. The FDA has since then negated this claim. After Trump's announcement, there was a rush for over the counter chloroquine, and this ended tragically for one Arizona man who consumed not-for-human-use chloroquine used to clean fish tanks. He sadly died due to the toxicity.
The Centre for Disease Control and Prevention (CDC), has warned the general public against taking non-pharmaceutical chloroquine phosphate and even medicinal chloroquine or hydroxychloroquine without prescription of a healthcare provider and always under the supervision of a healthcare provider because it can lead to "serious health consequences, including death."
The media attention on this drug has led to many doctors stockpiling hydroxychloroquine sold as Plaquenil and prescribing it for themselves and their family members. State pharmacy boards of Texas, Louisiana, North Carolina, and Ohio have thus limited the prescriptions the healthcare providers can write for the drugs.
However, there is no sound evidence in the form of clinical trials showing the efficacy of these agents in the treatment and prevention of COVID-19, say the officials.
Announcement from the Department of Health and Human Services
The Department of Health and Human Services this Sunday (29th of March 2020) issued a statement saying that both hydroxychloroquine and chloroquine products can "be distributed and prescribed by doctors to hospitalized teen and adult patients with COVID-19, as appropriate, when a clinical trial is not available or feasible."
Germany's Sandoz, said the officials had given 30 million doses of hydroxychloroquine to the Strategic National Stockpile. This stockpile is the government supply of essential medicines during public health emergencies. Bayer, too has donated one million doses of chloroquine to the government stockpile.
FDA and clinical trials
Approvals for clinical trials usually take time, say FDA officials. The clinical trials may take years. But with the current emergency and rising number of COVID-19 cases across the nation, the whole process is being fast-tracked, says the FDA. The USA, as of today, has recorded 188,547 cases and 3,899 deaths.
The clinical trials are planned for New York, the worst affected region, say officials. This emergency authorization was issued to measure the potential benefits against the harm caused by the treatment.
The Department of Health and Human Services said that there are "anecdotal reports suggest that these drugs may offer some benefit in the treatment of hospitalized COVID-19 patients, but clinical trials are needed to provide scientific evidence that these treatments are effective."
FDA's chief scientist, Denise Hinton, wrote in a letter of fast-tracked approval, saying, "It is reasonable to believe that chloroquine phosphate and hydroxychloroquine sulfate may be effective in treating COVID-19."
The rationale behind chloroquine and hydroxychloroquine in COVID-19 prevention and treatment
Chloroquine and hydroxychloroquine have been prescribed for the last several decades as a standard drug for the treatment of malaria and several autoimmune conditions such as systemic lupus erythematosus (SLE) and rheumatoid arthritis. These drugs are not free of adverse effects and have proved to be toxic to the eyes and the heart. Many users complain of irregular heartbeat and may develop arrhythmias, and cardiac arrest, say experts.
Clinical trial enrolment
Infectious disease specialist, Dr. David Boulware from the University of Minnesota at present is running two experimental trials to look at the efficacy of hydroxychloroquine in a large population. Enrolment for the studies are on at present and began around a couple of weeks ago. Persons interested can enroll in the study at trialcovid.com.
While one of his trials is looking at the preventive capacity of hydroxychloroquine to protect a healthy person from getting COVID-19 after being exposed to it, the other trial is to check if hydroxychloroquine can be used to reduce the rate of the severity of symptoms in COVID-19 positive patients and reduce their risk of getting hospitalized. This trial is including those patients who have begun to show symptoms. The cut off for their eligibility to enroll in the trial is four days after they become symptomatic. Those who enroll in the study will receive a package by post containing either active drug pills or placebo (inert pills) to be taken.
By the 30th of March, a total of 537 individuals have enrolled in the first prevention study, and 74 people with the early appearance of symptoms of COVID-19 have enrolled in the second trial. The final target is to enroll 1,500 participants in both trials. The dose of hydroxychloroquine given to participants is 800 milligrams at the start, along with 500 milligrams per day for the next five days.
At the end of two weeks after taking the drugs, the participants would have to fill at least four out of five questionnaires that ask them about the side effects, symptoms of COVID-19, and if they needed to be hospitalized. Recruitment would be completed within two weeks, and results from both trials are expected by the end of one month, say the researchers.
Dr. David Boulware said in his statement, "There's some suggestion that maybe it works, but there isn't any good data." He added, "If we're going to give this medicine to tens of thousands, or hundreds of thousands, or millions of people, we should know if it works." He said, "My goal is to figure out does it work. I don't know the answer, but we'll know soon."
Dr. Boulware explained, "The vast majority of people are not hospitalized. Besides social distancing and quarantine, if we can break that chain of infection by identifying somebody and then prophylaxis everyone around them that's been in contact with them to prevent infection, you can stamp out stuff much quicker."
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