Coronavirus update: Why WHO put a pause on hydroxychloroquine trials
by E Kumar SharmaCoronavirus crisis: WHO is currently assessing the use of hydroxychloroquine on COVID-19 patients within the Solidarity Trial. The hydroxychloroquine arm of the trial has been paused as a precaution while the safety data is being reviewed.
Among all the drugs that have the potential to be repurposed for possible use to combat coronavirus, the most talked about is hydroxychloroquine - a drug that is used in the treatment of rheumatoid arthritis and is considered better than its older version chloroquine, used in the treatment of malaria. Even US President Donald Trump is a vocal supporter of the drug. He sought supplies from India, pushing pharma companies like IPCA and Zydus Cadila into the limelight. It is also one of the drugs being studied by the World Health Organisation (WHO) under its 'Solidarity Trail'.
However, gradually, questions were raised and studies pointed to the adverse health impact of hydroxychloroquine on coronavirus patients. Triggered by some of these, the WHO put a temporary pause on the trials. India's Indian Council of Medical Research (ICMR) which recommends its use as a prophylactic drug, still maintains its stand.
Why exactly has the WHO put a temporary pause on HCQ trials? Chief Scientist at WHO Dr Soumya Swaminathan shed some light on the concerns regarding hydroxychloroquine in a WHO Q&A tweet.
Why is the use of hydroxychloroquine temporarily suspended in the Solidarity Trial?
In light of recent publications of evidence on the safety and efficacy of hydroxychloroquine as a treatment for coronavirus patients, the executive Group of the Solidarity Trial decided to implement a temporary pause on tests on HCQ as a precaution while the safety data is being reviewed, said the WHO Q&A tweeted by Swaminathan. As an example, an observational study published in Lancet on May 22 found that among 100,000 patients from multiple countries randomised to receive hydroxychloroquine, when used alone or with a macrolide, there was a higher mortality rate and an increased frequency of irregular heartbeats. A final decision on the harm, benefit or lack of benefit of HCQ will be made once the evidence has been reviewed by the Data Safety Monitoring Board, stated the document. This review will include data from the Solidarity Trial and other ongoing trials, as well as any evidence published so far. It is expected by mid-June.
What happens to people currently enrolled in the hydroxychloroquine arm of trial?
Patients previously randomised to hydroxychloroquine treatment should continue to receive it until they finish their course of treatment, stated the Q&A. The use of hydroxychloroquine and chloroquine are accepted as generally safe for use in patients with autoimmune diseases or malaria.
Also read: Coronavirus: WHO stops trial of hydroxycloroquine due to safety concerns
What is WHO's view of ongoing prophylaxis treatments followed in some countries including India?
WHO is currently assessing the use of hydroxychloroquine on COVID-19 patients within the Solidarity Trial, stated the document. The hydroxychloroquine arm has been paused as a precaution while the safety data is being reviewed. Every country, particularly those with regulatory authorities, is in a position to advise its citizens regarding the use of any drug. Although hydroxychloroquine and chloroquine are already licensed products for treating other diseases, at this stage, these drugs have not been found to be effective in the treatment of COVID-19, said WHO. In fact, warnings have been issued by many national authorities on the side effects of the drug and its use has been limited in many countries to clinical trials under strict supervision in hospital settings.
WHO has cautioned physicians against recommending or administering unproven treatments to coronavirus patients, and cautioned people against self-medicating with them. The consensus among world experts is that the potential exists but that far more studies are urgently needed to determine if existing antiviral drugs can be effective to treat COVID-19. If these treatments prove to be effective, they could reduce the burden of coronavirus.
Also read: Coronavirus crisis: ICMR approves HCQ for frontline COVID-19 warriors; Lancet has reservations
What is the Solidarity Trial?
The questions and answers around hydroxychloroquine says that the Solidarity Trial is an international clinical trial to help find an effective treatment for COVID-19, launched by WHO and partners. It said that based on data from laboratory and clinical studies, remdesivir, Lopinavir/Ritonavir, Lopinavir/Ritonavir with Interferon beta-1a, and hydroxychloroquine had been initially selected as treatment options. "Following new evidence on the safety and efficacy of hydroxychloroquine as a treatment for hospitalised COVID-19 patients, enrollment for this drug was temporarily suspended on 24 May 2020," it said.
Also read: Coronavirus: HCQ-azithromycin combination may be lethal, says US study
ICMR advisory
The Indian Council of Medical Research in its revised advisory on May 22, had recommended prophylactic use of hydroxychloroquine in select categories of people, including all asymptomatic healthcare workers involved in containment and treatment of coronavirus and asymptomatic healthcare workers working in non-coronavirus hospitals or non-COVID areas of corona hospitals and blocks. WHO is not asking countries to stop using it and apparently, every country is free to opt for what it wants and it is upto the regulators of every country to give permissions and their respective health ministries to issue the guidelines.
Also read: Setback for Zydus, IPCA; US, Europe warn against using Hydroxychloroquine to treat coronavirus