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Covid: Govt advises cautious use of Remdesivir; flags potential harm to liver, kidney

Investigational therapies to be carried out only in proper health care facilities, states told
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Aditi Tandon

Tribune News Service

New Delhi, July 11

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The government on Saturday warned against casual use of investigational therapies permitted in moderate to severely ill COVID patients saying such therapies should only be taken in hospital settings where patients’ condition for potential side effects can be monitored.

ICMR and AIIMS have specially warned states of evidence that anti-viral drug Remdesivir can potentially harm liver and kidneys and must be judiciously used.

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In a virtual conference on COVID management with states the ICMR experts said the available evidence for Remdesivir suggests it may decrease the time for clinical improvement when used in moderate to severe cases but it gives no benefits in terms of reduced mortality.

“Remdesivir has to be used with extreme caution due to its potential for serious adverse effects including liver and kidney injury.  Similarly, for Tocilizumab studies have not shown any benefits in mortality reduction. However, if used for patients with severe conditions, proper informed consent is required. Rampant use is to be discouraged since the effect of the drug is directed at the ‘cykotine storm’.

All investigational therapies are to be carried out only in proper health care facilities where close monitoring of patients is possible so that potential complications can be managed,” ICMR said.

ICMR strongly recommended that the focus of clinical management should continue to remain on oxygen therapy (including high flow nasal oxygen), steroids (which are widely available and inexpensive), appropriate & timely administration of anti-coagulants and high quality supportive care, including mental health counselling for patients and families, proning, management of pre-existing illness and palliation of symptoms.

Investigational therapies permitted in India for use in moderate to severely-ill COVID patients include Remdesivir, Tocilizumab, Plasma therapy, all under clinical trial stage with improved safety but allowed for emergency use on the basis of limited trial evidence.

ICMR said maintaining good hydration is also essential. “Based on severity of symptoms, COVID-19 can be categorised into 3 groups: mild, moderate and severe. For moderate and severe cases, adequate oxygen support, appropriate and timely administration of anti-coagulants and widely available and inexpensive corticosteroids, in accordance with the clinical management protocol, can be considered to be the mainstay of COVID-19 therapy.  For mild cases, which are nearly 80 per cent of the total cases, Hydroxychloroquine (HCQ) has been recommended. The standard of care treatment strategies have shown to yield positive results,” government said.

On investigational therapies ICMR said these can be used in specific sub-groups of patients on the basis of informed and shared decision making with the patient before prescribing these drugs.

“Remember that these drugs are only permitted for restricted emergency use for COVID-19. Their indiscriminate use or use in conditions for which they are not desirable, may cause more harm than good,” ICMR told states.

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