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Advisory on use of hydroxy-chloroquine as prophylaxis for SARS-CoV-2 infection

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Protocol recommended by National Task force has been approved by Drug Controller General of India for restricted use in emergency situations

The National Task force for COVID-19 constituted by Indian Council of Medical Research recommends the use of hydroxy- chloroquine for prophylaxis of SARS-CoV-2 infection for high risk population.

The advisory provides for placing the following high risk population under chemoprophylaxis with hydroxy chloroquine:

  • Asymptomatic healthcare workers involved in the care of suspected or confirmed cases of COVID-19
  • Asymptomatic household contacts of laboratory confirmed cases

The protocol recommended by the National Task force has been approved by the Drug Controller General of India for restricted use in emergency situations.

While following the above recommendations, States should take note of the following:

The placing of healthcare workers under chemoprophylaxis should not instill a sense of false security. They should follow all prescribed public health measures such as frequent washing of hands, respiratory etiquettes, keeping a distance of minimum one metre and use of personal protective equipment (wherever applicable).

They should self-monitor their health and report to health authorities immediately in the event of them becoming symptomatic.

The high risk contacts of a positive case placed under chemo prophylaxis, should remain in home quarantine while on prophylactic therapy.

As recommended by the said Task Force, the drug should only be given on the prescription of a registered medical practitioner. The contraindications mentioned in the recommendations should strictly be followed.

Apart from the symptoms of COVID-19 (fever, cough, breathing difficulty), if the person on chemo­prophylaxis develops any other symptoms, he should immediately seek medical treatment of the medical practitioner who has prescribed the chemoprophylaxis.

It is reiterated that the intake of the above medicine should not in still sense of false security.

Recommendation for empiric use of hydroxy-chloroquine for prophylaxis of SARS-CoV-2 _infection

Background:

Hydroxy-chloroquine is found to be effective against coronavirus in laboratory studies and in-vivo studies. Its use in prophylaxis is derived from available evidence of benefit as treatment and supported by pre-clinical data. The following recommendation for the use of hydroxy-chloroquine as a prophylactic agent against SARS-CoV-2 infection is based on these considerations, as well as risk-benefit consideration, under exceptional circumstances that call for the protection of high-risk individuals.

The National Taskforce for COVID-19 recommends the use of hydroxy-chloroquine for prophylaxis of SARS-CoV-2 infection for selected individuals as follows:

Eligible individuals:

Asymptomatic healthcare workers involved in the care of suspected or confirmed cases of COVID-19

Asymptomatic household contacts of laboratory confirmed cases

Dose:

Asymptomatic healthcare workers involved in the care of suspected or confirmed cases of COVID-19: 400 mg twice a day on Day one, followed by 400 mg once weekly for next seven weeks; to be taken with meals.

Asymptomatic household contacts of laboratory confirmed cases: 400 mg twice a day on Day one, followed by 400 mg once weekly for next three weeks; to be taken with meals.

Exclusion/contraindications:

The drug is not recommended for prophylaxis in children under 15 years of age.

The drug is contraindicated in persons with known case of retinopathy, known hypersensitivity to hydroxychloroquine, 4-aminoquinoline compounds.

Key considerations:

The drug has to be given only on the prescription of a registered medical practitioner.

Advised to consult with a physician for any adverse event or potential drug interaction before initiation of medication.

The prophylactic use of hydroxychloroquine to be coupled with the pharmacovigilance for adverse drug reactions through self-reporting using the Pharmacovigilance Programme of India (PvPI) helpline/app.

If anyone becomes symptomatic while on prophylaxis he/she should immediately contact the health facility, get tested as per national guidelines and follow the standard treatment protocol.

All asymptomatic contacts of laboratory confirmed cases should remain in home quarantine as per the national guidelines, even if they are on prophylactic therapy.

Simultaneously, proof of concept and pharmacokinetics studies be taken up expeditiously. Findings from these studies and other new evidence will guide any change in the recommendation.

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