MoHFW approves HCQS, Azithromycin combo for patients with severe Covid 19 disease

Ministry of Health and family welfare, Government of India has approved the use of hydroxychloroquine in combination with azithromycin for patients with severe disease and requiring ICU managements as a major change in the clinical management strategy for COVID-19 patients.

The Ministry of Health has released its revised Guidelines on Clinical Management of COVID–19 late on March 31.

The Health Ministry has noted that no specific antiviral have been proven to be effective as per currently available data. However, based on the available information (uncontrolled clinical trials), the following drugs may be considered.

It has, however, cautioned that the medication is presently not recommended for children less than 12 years, pregnant and lactating women. "The revised guidelines are based on currently available information and would be reviewed from time to time as new evidence emerges," it added.

The clinical management guideline-approved hydroxychloroquine (Dose 400mg BD – for 1 day followed by 200mg BD for 4 days) in combination with azithromycin (500 mg OD for 5 days) may be considered as an 'off–label' indication and is to be used under close monitoring including QTc interval.

This has followed after the US drug regulator's approval for two anti-malaria drugs, chloroquine and hydroxychloroquine, to treat patients infected by Sars-Cov-2. On March 30, the USFDA gave emergency use authorization to the two malaria drugs to be prescribed "as appropriate, when a clinical trial is not available or feasible".

The Indian Council of Medical Research had first approved the use of hydroxychloroquine as a prophylaxis, meaning as a preventive therapy, for high-risk individuals. All asymptomatic healthcare workers involved in care of COVID-19 patients and asymptomatic household contacts of laboratory confirmed cases were listed as high-risk individuals.

Despite multiple media queries, Indian health ministry or the ICMR has not disclosed the study papers or evidence that it used to approve HCQS as a prophylactic therapy for high-risk people earlier or as a treatment for critical patients now.

This document aims to provide clinicians with updated interim guidance on timely, effective, and safe supportive management of patients with COVID -19, particularly those with severe acute respiratory illness and critically ill," it adds.

"We are also offering support to treating physicians and AIIMS, New Delhi is running a 24x7 helpline to provide support to the treating physicians on clinical management. The helpline number is 9971876591. The identified nodal doctor of the State, appointed for clinical management of COVID – 19 should only contact AIIMS Call Centre," said a senior Health Ministry official.