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Kerala hospital begins HCQ clinical trial even after ICMR says no basis for such studies

The trial assumes the ICMR-recommended HCQ regimen is an ‘effective treatment’. However, ICMR chief epidemiologist says there isn’t enough evidence behind this.

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New Delhi: The Indian Council of Medical Research (ICMR) believes there is no basis for a clinical trial to test the efficacy of hydroxychloroquine (HCQ) as a preventive drug to tackle Covid-19. But a hospital in Kerala has begun work on a trial registered with the ICMR to study exactly this.

Speaking to ThePrint, Dr Remesh Bhasi of Aster Malabar Institute of Medical Sciences in Kozhikode said as many as 500 volunteers at the hospital are expected to be recruited in the trial and many were already taking HCQ as a prophylaxis.

“The trial is confined to our hospital staff only, and not open to the general public,” he said.

“This is going to be a two-month long study. We are going to prepare an interim report on the outcomes after two weeks,” Bhasi said, refusing to divulge any further details.

Bhasi spoke just days after ICMR epidemiology chief Raman Gangakhedkar told the media that there isn’t enough base evidence to conduct a clinical trial to test the efficacy of HCQ as a prophylaxis for Covid-19.

However, the Aster trial, which aims to compare two different regimens of hydrxychloroquine, is registered in the ICMR’s Clinical Trials Registry-India (CTRI).

According to the Union health ministry guidelines, a clinical trial for academic purposes doesn’t need approval from the Drug Controller General of India. It only needs approval from a local ethics committee. The Kerala trial has been approved by Aster’s ethics committee, according to Bhasi.

ThePrint reached the ICMR for a comment but there was no response until the time of publishing this report.

Issues with classification

The Kerala study has been classified as an ‘Active Controlled Trial’. Under such a trial, a known, effective treatment is compared with an experimental treatment.

In the Kerala trial, the ICMR regimen is being considered an ‘effective treatment’ despite the lack of evidence for it being seen as such.

Moreover, the study is described as a ‘Phase 3 trial’, which is conducted to confirm and expand on safety and effectiveness results obtained from Phase 1 and 2 trials. So far, no such trial has been reported on which a Phase 3 trial of HCQ as a prophylaxis can be based.

On Saturday, Gangakhedkar said during a press briefing that ICMR is conducting an ‘observational cohort study’ on the effects of HCQ on about 480 health workers.

He made it clear that a clinical trial cannot be designed at this point.

The ICMR chief epidemiologist added that some of the workers had self-medicated themselves with the drug and experienced side effects.

The study of these workers, with an average age of 35 years, revealed that 10 per cent of those who took the drug experienced abdominal pain, while six per cent reported nausea like symptoms. About 1.3 per cent had hypoglycemia or low blood sugar, said Gangakhedkar.


Also read: How the humble hydroxychloroquine has become India’s unlikely new global strategic asset


What the trial will do

Under Bhasi’s guidance, the trial will follow two groups who will be given separate regimens of hydroxychloroquine – including one recommended by the ICMR last month.

The first group will follow the ICMR regimen – 400 mg doses twice on the first day, followed by 400 mg weekly for seven weeks, to be taken with meals or until the epidemic stops.

The other group will take 300 mg doses daily for seven days, followed by 300 mg weekly for seven weeks.

Both groups will follow strict measures of self hygiene, social distancing and other routine protocols issued by the Indian Medical Association and government bodies to prevent transmission of Covid-19.

Previous research

Despite the hype over the potential benefits of the anti-malarial drug courtesy the endorsement by US President Donald Trump, the benefits of hydroxychloroquine as a treatment or preventive drug against Covid-19 is yet to be established.

In an article published in The Lancet journal, researchers from Mahatma Gandhi Institute of Medical Sciences (Sevagram, Maharashtra) and Safdarjung Hospital (Delhi) wrote, “Although some in-vitro evidence supports the antiviral activity of hydroxychloroquine and its precursor chloroquine, there is no peer-reviewed publication that evaluates either drug for exposure prophylaxis of SARS-CoV-2 infection.”

The researchers also said that this lack of evidence “hardly justifies state-endorsed, widespread use of hydroxychloroquine for prophylaxis”.

A review published in the Canadian Medical Association Journal warned that HCQ can cause cardiac arrhythmias (irregular heartbeats), low blood sugar, and neuropsychiatric effects such as agitation, confusion, hallucination and paranoia.

An overdose of HCQ, which is highly toxic, can cause seizures, coma, and cardiac arrest, the review suggests, cautioning that these medicines could worsen the disease.


Also read: This Indore hospital ‘first in India’ to try TCZ in critical Covid cases, claims good results


 

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