Health ministry allows use of HCQ in early stages of COVID-19, Remdesivir in moderate patients as infections climb over 3.2 lakh

New Delhi: As the number of COVID-19 cases crossed the three lakh-mark, the government on Saturday came out with a revised treatment protocol to deal with the deadly infection, allowing use of antiviral drug Remdesivir in moderate cases and hydroxychloroquine in patients during the early course of the disease.

It also recommended an off-label application of Tocilizumab, a drug that modifies the immune system or its functioning, and convalescent plasma for treating coronavirus-infected patients in moderate stage of the illness, besides adding loss of smell or taste to the list of COVID-19 symptoms.

In its revised ''Clinical Management Protocols for COVID-19'', the Union health ministry, in a turnaround from its earlier decision, advised use of the anti-malarial drug hydroxychloroquine in the early course of the disease, while dropping the use of azithromycin in combination with HCQ in severe cases and those requiring ICU management.

Ten days after recording two lakh COVID-19 cases, India surpassed the three lakh-mark on Saturday with the worst daily spike of 11,458 infections, while the death toll too climbed to 8,884 with 386 new fatalities, according to the Health Ministry.

India took 64 days to cross the one lakh-mark from 100 cases, then in another fortnight it reached the grim milestone of two lakh cases. It has now become the fourth worst-hit nation with a caseload of 3,08,993. Only US, Brazil and Russia have more cases.

Hydroxychloroquine has demonstrated in-vitro activity against SARS-CoV2 and was shown to be clinically beneficial in several small single-centre studies though with significant limitations, the health ministry said.

"Nonetheless, several large observational studies with severe methodologic limitations have shown no effect on mortality or other clinically meaningful outcomes," the revised document said.

"As such, the evidence base behind its use remains limited as with other drugs and should only be used after shared decision making with the patients while awaiting the results of ongoing studies," it said.

As is the case with other antivirals, this drug should be used as early in the disease course as possible to achieve any meaningful effects and should be avoided in patients with severe disease, the health ministry said, adding that an ECG should ideally be done before prescribing the drug.

Under emergency use authorisation, Remdesivir may be considered for patients in moderate stage requiring oxygen support. It is not recommended for those with severe renal impairment and high level of liver enzymes, pregnant and lactating women, and those below 12 years, the document stated.

The drug, administered in the form of injection, should be given at a dose of 200 mg on day one followed by 100 mg daily for five days.

According to the revised protocols, convalescent plasma therapy may be considered for patients with moderate illness with no improvement in condition despite the use of steroids.

The therapy involves taking antibodies from the blood of a person who has recovered from COVID-19 and transfusing those to a coronavirus patient to help kickstart the immune system to fight the infection.

The recipient should be closely monitored for several hours after transfusion for any adverse events and its use should be avoided in patients with immunoglobulin A deficiency or immunoglobulin allergy.

"The dose is variable ranging from 4 to 13 ml/kg -- usually 200 ml single dose given slowly over not less than two hours," the revised document stated.

The guidelines state that tocilizumab may be considered in patients with moderate illness with progressive increase in oxygen requirement and in mechanically ventilated patients not improving despite the use of steroids.

Long term safety data in COVID-19 remains largely unknown, the guidelines stated.

The presence of raised inflammatory markers should be checked before its use and the patient should be carefully monitored after tocilizumab is administered for secondary infections and neutropenia. Active infections and tuberculosis should be ruled out before use, it stated.

For patients with progressive deterioration of oxygenation indicators, rapid worsening on imaging and excessive activation of the body''s inflammatory response, glucocorticoids can be used for a short period of time.

Larger dose of glucocorticoids, a class of steroid hormones, will delay the removal of coronavirus due to immunosuppressive effects, the revised document stated.

The ministry said that coronavirus-infected patients reporting to various COVID-19 treatment facilities have been reporting symptoms like fever, cough, fatigue, shortness of breath, expectoration, myalgia, rhinorrhea, sore throat and diarrhoea.

They have also complained of loss of smell (anosmia) or loss of taste (ageusia) preceding the onset of respiratory symptoms.

The ministry said the use of Remdesivir, Tocilizumab and convalescent plasma therapy, at present, is based on limited available evidence. As the situation evolves and when more data become available, the evidence will be accordingly incorporated, and recommendation upgraded, it stated.

Meanwhile, the ministry's data updated on Sunday showed active cases at 3,20,922 and those who have recovered at 1.62,379. The toll stands at 9,195.

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Press Trust of India