TGI initiates a randomised Control trial of Hydroxychloroquine for Health Care Workers exposed to COVID

Healthcare workers involved in the care of hospitalized COVID-19 patients are at high risk of contracting the infection, even with the conscientious use of personal protective equipment. According to WHO estimates, health workers account for 10 per cent of all COVID-19 related infections in the world. In Delhi alone, more than 2000 healthcare workers have tested positive for COVID-19.

Many doctors and nurses have died serving COVID-19 patients in intensive care units of hospitals. The Indian Medical Association estimates that COVID-19 has taken the lives of more than 200 doctors in India. In Italy, healthcare workers account for 10 per cent of all COVID-19 related deaths.

The loss of the healthcare workforce either because of illness or the need for quarantining will seriously impede efforts at controlling the pandemic.

There is biological plausibility that hydroxychloroquine (HCQ) will provide effective prophylaxis against SARS-CoV-2 infection based on its ability to reduce binding of the virus to the ACE2 receptor, prevent cellular entry of the virus and inhibit viral replication.

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

To assess the efficacy of hydroxychloroquine (HCQ) as compared to standard care for the prevention of COVID-19 infections among healthcare workers exposed to SARS-CoV2, the George Institute for Global Health India has initiated a 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 COVID-19 disease.

According to Dr Bharath Kumar, Consultant in Critical Care, Apollo Hospitals Chennai and Honorary Fellow at the George Institute for Global Health India, the study pans to recruit 7000 health care workers. Study participants will be randomised to two arms: one will receive weekly HCQ in addition to standard practice PPE. In the control arm, only standard practice PPE will be given. Proportion of COVID-19 infection in both arms will be tested at 6 months.

“The study will also monitor hospitalization due to suspected COVID-19, admission to an intensive care units, deaths or other organ failure, length of stay and need for readmission to hospital, and days off work.” added Dr Bharath Kumar.

Subject enrolment has started in three centres in India – Apollo Hospitals, Chennai, Christian Hospital, Odisha, and Apollo Indraprastha, Delhi, and more centres are being added. With the aim to extend the study to 25 to 30 hospitals in India.

“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,” says Prof Vivekanand Jha, the study coordinator and Executive Director of the George Institute for Global Health, India.

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.

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