ICMR study shows side effects of HCQ in health care staff
Some side effects, such as abdominal pain and nausea have been observed in healthcare workers, who are a part of the study being conducted in India, to look at the prophylactic (preventive) effects of the anti-malaria drug, hydroxychloroquine (HCQ), against the coronavirus disease (Covid-19), said the Indian Council of Medical Research (ICMR) on Saturday.
The ICMR said that it was conducting a two-arm study on the prophylactic (prevention) and therapeutic (treatment) effects of HCQ against Covid-19.
“The average age of those who showed side effects against the drug was 35 years. The most common complaint was of abdominal pain that was reported by about 10% of those who took the medicine; 6% reported experiencing nausea, and the other effects were of less proportion such as 1.3% complaining of hypoglycemia [low blood sugar levels],” said Dr Raman R Gangakhedkar, head, epidemiology and communicable disease division, ICMR, who is supervising the trials on behalf of ICMR.
Of those healthcare workers who reported adverse drug reaction, about 22% suffered from some underlying medical conditions, such as diabetes, blood pressure, cardiovascular or respiratory disease.
“We observed that despite being healthcare workers themselves, about 14% had not even got their ECGs done to check their heart function before. It seems they were aware of their health condition which made them volunteer to take the medicine so that they would get protection against infection,” said Dr Gangakhedkar.
Another observational study is being done to know its treatment benefits among Covid-19 patients,
The observational study is being done in a cohort of 480 Covid-19 patients, who will be given a specific doze of HCQ along with the antibiotic, azithromycin, for eight weeks.
“It will take about two and a half months to get done with the study and know the results as we are working under restricted research conditions because of the lockdown. The All India Institute of Medical Sciences is the nodal site for both the studies,” said Gangakhedkar.
On whether any study was being done in India to check the efficacy of the anti-viral drug, Remdesivir, which has shown promise in stopping the replication mechanism of coronaviruses, including SARS-CoV-2, which causes Covid-19, Dr Gangakhedkar said that India was a part of World Health Organization’s (WHO) SOLIDARITY trial, and Remdesivir was one of the trial arms.
“It is the Gilead company’s product, and they say in about 68% of the Covid-19 patients, it has been effective in reducing oxygen support. However, this conclusion is not a part of any clinical trial but an observational study for which the drug was given to patients on compassionate grounds. Now it has started a trial on 5,500 patients to check the dosage efficacy of five days vs. 10 days. However, even an interim analysis of it isn’t out yet. There is some time before we get any concrete evidence, and in some time, if we find it’s working, we will act accordingly,” said Gangakhedkar.
“Though Gilead company has a patent on this drug molecule, during pandemic situations, company’s charge some royalty from generic manufacturers and allow them to manufacture the drug,” he added.