Medical research institute in India starts HCQ efficacy trial

The George Institute of India has initiated a trial to assess the efficacy of Hydroxychloroquine. The trial will test if the HCQ would reduce the risk of acquiring SARS-CoV-2 infection in frontline healthcare professionals.

New Delhi: In an effort to assess the efficacy of Hydroxychloroquine (HCQ) as compared to standard care for the prevention of COVID 19 infections among the healthcare workers exposed to SARS-CoV2, India's leading independent medical research institute, George Institute of India (GII) has initiated a randomised control trial (RCT) of HCQ for health workers.

The trial involving administration of a dose of 400mg of oral HCQ weekly (after an 800mg HCQ loading dose).

The trial will test if this would reduce the risk of acquiring laboratory-confirmed SARS-CoV-2 infection in frontline healthcare professionals caring for patients with known or suspected Covid19 disease.

The study plans to recruit 7000 healthcare workers. Officials said that participants will be randomised to two arms: one will receive weekly HCQ in addition to standard practice PPE. For another, the standard practice of PPE will be given.

The proportion of COVID 19 infection in both arms will be tested for 6 months.

With an aim to extend the study to 25 to 30 hospitals in India, subject enrolment has already started in three centres namely Apollo Hospital Chennai, Christian Hospital Odisha and Apollo Indraprastha, Delhi.

The study has been approved by the Institutional Ethics Committee of George Institute for Global Health India and by the ethics committees from other participating hospitals.

The trial to ascertain the efficacy of Hydroxychloroquine assumes significance as near about 200 doctors have lost their lives due to COVID 19. Numbers of healthcare workers have been infected by the disease.

Talking to ETV Bharat, Dr. Giridhar Gyani, director general of Association of Health Care Providers-India said that such trial was very much necessary as this could ascertain the efficacy of HCQ which is being given to frontline health workers as a COVID shield.

He said that the usefulness of HCQ in Covid19 is not clearly backed by clear evidences.

While WHO has earlier endorsed HCQ, but later on it said that Hydroxy-chloroquine does not have any clinical benefits.

It may be mentioned here that the Indian Council of Medical Research (ICMR) earlier did research on HCQ benefits on healthcare workers but the methodology of their study was questioned by doctors from AIIMS.

ICMR conducted the study only on "COVID symptomatic" participants. The ICMR further said that any changes to HCQ dosage can only be done after conducting appropriate laboratory studies.