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Modi govt expert panel green lights clinical trial of tapeworm infection drug to treat Covid

The drug niclosamide was earlier used on patients with SARS during the 2004 outbreak, and is considered a promising option for Covid-19. 

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New Delhi: The Narendra Modi government’s expert panel has given its approval to a Telangana-based drug discovery company to test a tapeworm infections drug, Niclosamide, to treat Covid-19.

The subject expert committee (SEC) — which advises apex regulator Drug Controller General of India (DCGI) on applications seeking approvals for new drugs, vaccines, and clinical trials — has granted permission to conduct phase 2 clinical trials on antihelminitic medication, a category of drugs used to treat infections of animals with parasitic worms.

The drug works by killing tapeworms that cause infection and the worms are then passed in the stool. Last year, the US initiated phase 2 and 3 trials of the drug against Covid-19. These are currently underway.

In 2004, during the severe acute respiratory syndrome (SARS) outbreak, studies showed that “niclosamide was able to inhibit replication of a newly discovered coronavirus, SARS-CoV.”

Niclosamide, during the epidemic, was claimed to be “a promising drug candidate for the effective treatment of SARS-CoV infection.”

The Institut Pasteur Korea, an infectious disease research institute, ranks the drug as first among many candidate drugs for the treatment of Covid-19.

The decision to approve the phase 2 trial was taken by the SEC during a meeting on 23 March. The minutes of the meeting were uploaded on the website of the Central Drugs Standard Control Organisation (CDSCO) — the health ministry arm that regulates the quality of drugs and vaccines in the country.


Also read: 12 months, 12 lessons: What India learnt about Covid in a year since lockdown began


Recommendations by SEC

In India, the drug will be tested for the treatment of hospitalised Covid-19 patients.

The drug discovery firm, Laxai Life, presented the proposal to start phase 2 clinical trial along with a designed protocol.

The panel recommended the company revise the trial protocol by modifying the dose of the drug. “The dose should be stated as 2g (500mg x 4 tablets) throughout the protocol,” it said.

It also recommended that the trial only include patients with 90–93 per cent of oxygen saturation level (SpO2). Patients with less than 90 per cent SpO2 are to be excluded from the study.

Further, patients with systolic blood pressure less than 100 mm of mercury are to be excluded.

“Number of sites is to be increased to expedite the recruitment of patients … Vaccination status of patients enrolled in the study are to be recorded. Accordingly, the firm should submit the revised protocol to CDSCO,” it said.

(Edited by Manasa Mohan)


Also read: India’s cancer problem — not enough clinical trials and lack of access to those being done


 

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