George Institute begins HCQ trials for healthcare workers exposed to virus
New Delhi: Amid several conflicting reports from researchers across the world on the efficacy of hydroxychloroquine for treating COVID-19, the George Institute for Global Health has started a randomised control trial for HCQ on healthcare workers from across the country who were exposed to SARS-CoV-2. One of the centres for the trial is at Delhi's Apollo Indraprastha and the other two centres are based out of Chennai and Odisha, where subject enrolment has begun.
The George Institute for Global Health India has started the trial involving administering a dose of 400mg of oral HCQ weekly (after an 800mg HCQ loading dose). The trial will test if this treatment plan would reduce the risk of acquiring laboratory-confirmed SARS-CoV-2 infection in frontline healthcare professionals caring for patients with known or suspected COVID-19.
According to Dr Bharath Kumar, Consultant in Critical Care, Apollo Hospitals and Honorary Fellow at the George Institute for Global Health India, the study plans to recruit 7,000 healthcare workers. Study participants will be randomised by two arms: one will receive weekly HCQ in addition to standard practice PPE. In the control arm, only standard practice PPE will be given. The proportion of COVID-19 infection in both arms will be tested at 6 months.
"The study will also monitor hospitalisation due to suspected COVID-19, admission to an intensive care unit, deaths or other organ failures, length of stay and need for readmission to hospital, and days off work," Dr Bharath Kumar said.
"HCQ has a favourable adverse effect profile and has been in use for several diseases like rheumatoid arthritis and systemic lupus erythematosus for several years. Most adverse effects are minor and can be managed easily. Patients will undergo an electrocardiogram to identify those who might be at risk of developing a rare side effect," Prof Vivekanand Jha, the study coordinator and Executive Director of the George Institute for Global Health, India said.
There is biological plausibility that hydroxychloroquine (HCQ) will provide effective prophylaxis against SARS-CoV-2 infection based on its ability to reduce the binding of the virus to the ACE2 receptor, prevent cellular entry of the virus and inhibit viral replication, according to experts.
"The usefulness of HCQ in COVID-19 is not clearly backed by evidence one way or the other. While WHO endorsed the use of HCQ early on in the fight against COVID-19, it changed its stand later saying that existing studies show that HCQ does not have any clinical benefits and more decisive research is needed to assess its value in patients exposed to COVID-19," said a statement by the George Institute.