New Delhi: The Narendra Modi government’s expert panel has asked US-headquartered contract research organisation (CRO) Tech Observer for more data before it takes up the latter’s request to test the usage of blood thinners in mild cases of Covid-19.
The CRO (a company that provides support to a pharmaceutical firm to conduct clinical trial and research activities on an outsourced, contract basis) had submitted the proposal to test pharma major Sanofi’s anticoagulant drug, Clexane.
The drug, which is known as Enoxaparin in generic terms, is a blood thinner or an anticoagulant which is used to prevent and treat blood clots, including in cases of deep vein thrombosis or pulmonary embolism.
According to multiple studies, severely ill Covid-19 patients suffer from pneumonia, acute inflammation and blood clots, of which the last two together have been seen to cause organ failure and death.
More data needed, says panel
Tech Observer’s proposal was submitted before the government’s Subject Expert Committee, which advises the Drugs Controller General of India on applications seeking approvals for new drugs, vaccines and clinical trials. While Indian treatment protocol recommends the use of blood thinners in moderate to severe patients, the trial seeks permission to test the efficacy among mild cases. According to the minutes of the meeting held on 26 October, which have been uploaded on the Central Drugs Standard Control Organisation (CDSCO) website, the committee has asked the company to submit “justification for conduct of the trial in mild cases.”
Further, it has also asked the CRO to provide the “definition of symptomatic care in inclusion criteria” in the protocol. Also, it has requested that baseline risk assessment of bleeding due to the use of blood thinners should be clearly defined in the protocol.
“The protocol for monitoring of the patient at home should be detailed,” it said while adding that the company “must obtain the data from the study centres regarding their involvement in the ongoing home care management” along with the protocol for “the adverse event monitoring and management in home care.”
The Central government panel has also recommended finding out the “status of the study protocol in the UK, France, Australia etc.”
“Accordingly, the firm should submit the above data to CDSCO for further review by the committee,” it concluded.
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