New Delhi: Gujarat-based drugmaker Intas Pharmaceuticals has received the go-ahead from the Modi government’s expert panel to conduct phase 2 clinical trials on Covid-19 patients using “hyperimmune globulin” — a drug made from convalescent plasma.
Hyperimmune globulin is manufactured by pooling plasma from recovered patients. The plasma is then concentrated and purified through heat to kill the remaining pathogens. Eventually, it is administered as a vial of medicine, which consists of antibodies. It mostly consists of immunoglobulin G, or IgG, which gives long-term immunity.
Unlike plasma transfusions, the benefit of this drug is that it does not require matching of blood types. Also, it is known for delivering a standardised dose to patients unlike plasma transfusions where the range of antibodies varies donor to donor.
According to the minutes of the 21 August meeting — accessed by ThePrint — of the subject expert committee (SEC) to evaluate Covid-19 applications: “…the firm presented their proposal along with the Phase-II clinical trial protocol. After detailed deliberation, the committee recommended for grant of permission for conduct of the proposed Phase-II clinical trial….”
SEC is a body under the Central Drugs Standard Control Organisation, which is a health ministry arm that regulates the quality of drugs and vaccines in the country.
Another drug-maker, Hyderabad-based Virchow Biotech, has reached the panel to conduct trials on the same drug.
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Patient should be followed up for 28 days
The committee has approved the phase 2 trials based on two conditions where it has asked the Ahmedabad-based drug-maker to “actively” follow up on patients who will be administered the hyperimmune globulin for upto 28 days.
The panel has also said the patients “should not be given convalescent plasma therapy during the trial”.
The firm in July had applied for the approval. However, the panel had then asked the firm to submit “validation data of percentage inhibition of neutralisation antibodies on live virus culture (in vivo study) from National Institute of Virology, Pune”.
“Application for the proposed Phase-II clinical trial will be considered based on submission of the above data,” said the committee, according to the minutes of the meeting held in July.
Hyperimmune globulin was explored in SARS
According to an article published in The Lancet in April: “A rapidly implementable approach to the development of antivirals is the use of plasma-derived polyclonal hyperimmune globulin… Such approaches have been explored for patients with viral pneumonia, including SARS and severe influenza.”
The article said, “The results have been mostly positive although many of such therapies have not been formally evaluated through a randomised, double-blind, placebo-controlled clinical trial.”
Theoretically, it said, “High titers of neutralising antibodies could reduce viral dissemination from infected to uninfected cells in the respiratory tract. When given soon after illness onset, this therapy could thus not only prevent disease progression, it could also lead to more rapid viral clearance and hence patient de-isolation.”
However, it also added that “both hyperimmune globulin and vaccine development face a common hurdle — the risk of antibody-mediated disease enhancement.”
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