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Health Ministry issues fresh clinical management protocol for COVID-19 patients

The patient can be administered with 200 mg IV on day 1 followed by 100 mg IV daily for five days. The drug cannot be administered to a pregnant or lactating mother and children below the age of 12 years. Also, the patient should not have liver problems and renal complications.

New Delhi: The Union Health Ministry issued a fresh clinical management protocol for COVID-19 patients on Saturday. As per the latest protocol, the health ministry has described the use of investigational therapies–Remdesivir, Convalescent plasma, Tocilizumab, and Hydroxychloroquine (HCQ) on coronavirus patients.

The government has included loss of smell and taste as new symptoms of coronavirus, however, they have withdrawn the use of Azithromycin drug in the management of COVID-19 patients. Further, the use of these drugs is subjected to limited availability in the country as of now.

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Currently, these drugs should only be used in a defined subgroup of patients:

The antiviral drug–Remdesivir (for restricted emergency use) may be considered in patients with moderate disease (those on oxygen). The patient can be administered with 200 mg IV on day 1 followed by 100 mg IV daily for five days. The drug cannot be administered to a pregnant or lactating mother and children below the age of 12 years. Also, the patient should not have liver problems and renal complications.

Convalescent plasma therapy may be considered in patients with the moderate disease who are not improving (oxygen requirement is progressively increasing) despite the use of steroids. The dose for convalescent plasma can be variable ranging from 4 to 13 ml/kg (usually 200 ml single dose given slowly over not less than two hours).

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“There are special prerequisites while considering convalescent plasma. It includes ABO compatibility and cross-matching of the donor plasma. The recipient should be closely monitored for several hours post-transfusion for any transfusion related adverse events. However, the use of convalescent plasma should be avoided in patients with IgA deficiency or immunoglobulin allergy,” read clinical guidelines.

The use of Tocilizumab drug may be considered in patients with moderate diseases with progressively increasing oxygen requirements. The drug can also be used on patients on ventilators whose condition is not improving despite the use of steroids. But, long term safety data in COVID-19 remains largely unknown, it said.

“Patient needs to be monitored for raised inflammatory markers in the body. Post Tocilizumab, the patient should be carefully monitored for secondary infections and neutropenia. Also, active infections and tuberculosis should be ruled out before use,” it said.

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As per the government, the dose for Tocilizumab is 8mg/kg (maximum 800 mg at one time) given slowly in 100 ml NS over one hour; dose can be repeated once after 12 to 24 hours if needed, read the government document.

In the case of anti-malaria drug HCQ, it should be used as early in the disease course as possible to achieve any meaningful effects and should be avoided in patients with severe cases.

“An ECG should ideally be done before prescribing the drug to measure QTc interval and HCQ avoided if QTc is >500 ms,” it stated.

 

Upon being contacted, Dr Vikas Maurya, Head of Respiratory Medicine department said: “I think, it is a welcome step. This latest clinical management protocol for COVID-19 patients will provide universal guidelines for doctors across India. Beneficial for both patients and doctors.”

While explaining the usage of these investigational drugs, the health ministry clearly said that at present there was limited available evidence. As the situation evolves, and as more data becomes available, the evidence would be accordingly incorporated, and recommendations would be upgraded. (ANI)