Coronavirus | Avoid hydroxychloroquine in COVID-19 patients with severe disease, says Health Ministry protocol

A vial of the drug remdesivir is inspected at a Gilead manufacturing site in the U.S. (Representational image.)   | Photo Credit: AP

The Health Ministry on Saturday said the anti-malarial drug hydroxychloroquine (HCQ) should be used as early as possible in the course of coronavirus (COVID-19) treatment to achieve any meaningful effects and should be avoided in patients with severe disease.

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A 22-page new, national clinical management protocol provides for the management of COVID-19 cases based on the clinical severity of mild, moderate or severe, the Health Ministry said.

India’s new protocol now includes use of remdesivir and off-label use of tocilizumab and convalescent plasma therapy on very specific groups of patients. Also while HCQ will continue to be in use, antibiotic azithromycin is no longer a part of the treatment protocol.

As per the latest protocol the Ministry said COVID-19 patients are reporting various symptoms including fever, cough, fatigue, shortness of breath, along with other symptoms. “Loss of smell (anosmia) or loss of taste (ageusia) preceding the onset of respiratory symptoms has also been reported,” the protocol said.

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It added that older people and immune-suppressed patients in particular may present with atypical symptoms such as fatigue, reduced alertness, reduced mobility, diarrhoea, loss of appetite, delirium, and absence of fever. Children might not have reported fever or cough as frequently as adults.

The major risk factors for severe disease include — age more than 60 years (increasing with age), underlying non-communicable diseases (NCDs) — diabetes, hypertension, cardiac disease, chronic lung disease, cerebro-vascular disease, chronic kidney disease, immune-suppression and cancer.

The indications about repurposed or off-label therapy HCQ states that this drug has demonstrated in vitro activity against SARS-CoV-2 and was shown to be clinically beneficial in several small, single-center studies, though with significant limitations.

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“Infection prevention and control practices have also been specified according to the three stages of severity. These guidelines also specify investigational therapies for a defined sub-group of patients. However, an informed and shared decision-making is essential before prescribing any of these therapies,” it added.

“Nonetheless, several large observational studies with severe methodologic limitations have shown no effect on mortality or other clinically meaningful outcomes. 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. 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. An ECG should ideally be done before prescribing the drug,” the protocol states.

 The Health Ministry has added that as per current available evidence (SARS-CoV-2) has a zoonotic source closely related to bat-origin SARS-like coronavirus and persons infected by the novel coronavirus are the main source of infection.

It added that the median incubation period is 5.1 days (range 2–14 days) and that the precise interval during which an individual with COVID-19 is infectious is uncertain.

“As per the current evidence, the period of infectivity starts two days prior to onset of symptoms and lasts up to 8 days. The extent and role played by pre-clinical/ asymptomatic infections in transmission still remain under investigation,’’ noted the Ministry.

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Printable version | Sep 22, 2021 4:37:09 AM |

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