The notice was issued on Wednesday in reference to Union health ministry's clinical management protocols for COVID-19 released on June 27.
Convalescent plasma may be considered in moderate COVID-19 patients who are not improving despite use of steroids, stated a notice issued by the Central Drugs Standard Control Organisation (CDSCO). The notice was issued on Wednesday in reference to Union health ministry’s clinical management protocols for COVID-19 released on June 27. The ministry had allowed use of convalescent plasma (off-label) for treating coronavirus patients in moderate stage of the illness under “investigational therapies”.
“This is with reference to the clinical management protocols for COVID-19 issued by the Government of India, Ministry of Health wherein, certain therapies are indicated for use as investigational therapies, in which convalescent plasma by plasmapheresis has been indicated as off-label in COVID-19 patients,” the CDSCO notice, ‘Information on Convalescent Plasma in COVID-19’, said.
“Convalescent plasma may be considered in patients with moderate disease who are not improving (oxygen requirement is progressively increasing) despite use of steroids,” it added.
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The therapy involves taking antibodies from the blood of a person who has recovered from COVID-19 and transfusing those into a coronavirus-infected patient to help kickstart the immune system to fight the infection.
ABO compatibility and cross matching of the donor ‘plasma’ is a prerequisite while considering convalescent plasma, the health ministry has said. The recipient should be closely monitored for several hours after transfusion for any adverse events and its use should be avoided in patients with immunoglobulin A deficiency or immunoglobulin allergy.
“The dose is variable ranging from 4 to 13 ml/kg — usually 200 ml single dose given slowly over not less than two hours,” according to the clinical management protocols. India’s COVID-19 tally crossed the six lakh-mark on Thursday, while the death-toll rose to 17,834, according to the Union health ministry update at 8 am.