Inclusion of cancer drug in WHO Covid Solidarity trial: CDSCO panel asks ICMR to submit more clarification

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The committee noted that presently, Remdesivir and Dexamethasone are used as part of treatment in such COVID patients. However, as per the proposal, such patients included in the Acalabrutinib arm may not receive these drugs.

Remdesivir is an intravenous antiviral drug sold by US pharmaceutical company Gilead Sciences Inc. while dexamethasone is a steroid, which is part of India's approved clinical management protocol for Covid-19.

It further pointed out, "One Global clinical trial of Acalbrutinib is ongoing in various countries including India."

Furthermore, the committee stated that it was informed that during the presentation, the results on Remdesivir from the Solidarity trial may be available in a few weeks. Subsequently, the Committee held;

In view of the above, the committee after detailed deliberation recommended that more clarification/justification for inclusion of Acalabrutinib arm in the Solidarity trial will be required before including the arm at present.