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ICMR to continue restricted use of HCQ amid doubts
In the US study that came on April 16, the researchers analysed medical records of 368 hospitalised patients with confirmed coronavirus infection at Veterans Health Administration medical centres
The Indian Council of Medical Research (ICMR) will continue restricted use of the anti-malarial drug, hydroxychloroquine (HCQ), to treat ICU patients as part of its demonstration study even after a US study found it brought no benefit to 368 people with the coronavirus disease (Covid-19).
“We are generating our own data, and will take a decision, according to our own results. The study to check its therapeutic use will take about 2-2.5 months to complete which should provide us the evidence against or for it. It will be too premature to say anything at this stage even though we are closely looking at all the data coming from other countries,” said an official in the ICMR, who did not wish to be identified.
In the US study that came on April 16, the researchers analysed medical records of 368 hospitalised patients with confirmed coronavirus infection at Veterans Health Administration medical centres. About 28%, who were given HCQ in addition to the usual care died, versus 11% of those getting routine care alone. The drug made no difference in the need for a breathing machine, either, according to the study.
However, Switzerland-based drug maker Novartis announced a few days ago that it had reached an agreement with the US Food and Drug Administration to carry out a Phase III trial assessing HCQ as a treatment for hospitalised Covid-19 patients, for which it will be recruiting about 440 patients in at least a dozen sites in the US.
In India, the central drugs controller towards the end of March had approved the use of HCQ under the “restricted use” category, primarily for the studies that ICMR wanted to carry out.
The ICMR has said that it is conducting a two-arm study on the prophylactic (prevention) and therapeutic (treatment) effects of HCQ against covid-19.
As prophylactic, the drug has been recommended for asymptomatic health care workers involved in the care of suspected or confirmed cases of Covid-19, and, as therapeutic medicine, it is being given to critically ill Covid-19 patients in the intensive care unit (ICU) to see if their dependency on oxygen support is reduced.
The therapeutic study is being done in a cohort of 480 Covid-19 patients.
In India, around 2% of Covid-19 cases need critical care in ICUs, according to the health ministry.
In prophylactic cases, the drug is recommended to be taken under strict medical supervision, considering all contraindications.
The dosage given to people in India is 400mg, twice a day, for one day, and subsequently 400mg once a week. The course is recommended for seven weeks for prophylactics. In case of treatment it, is being given in combination with the antibiotic, azithromycin.
“In positive patients, the medicine has shown to reduce the viral load, and our aim is to see whether it will prevent infection or not,” Dr Raman R Gangakhedkar had said earlier.
While results from the treatment cohort will take time, the initial data collected from reactions found in health care workers showed two primary complains: abdominal pain in about 10% of those who took the medicine; and nausea in about 6% of them.
“If the results aren’t satisfactory, the drug will be withdrawn, like it was previously done with HIV/AIDS antiviral drugs, such as lopinavir and ritonavir, which did not show much benefit,” the ICMR official added.
