During the trial, one group of patients received convalescent plasma therapy together with the standard supportive treatment, while the other group received only the standard treatment (Express Photo).
Convalescent plasma therapy showed no benefit in reducing mortality risk among COVID-19 patients, based on an interim analysis of a randomized controlled trial conducted at AIIMS here to assess the efficacy of this mode of treatment.
The therapy involves taking antibodies from the blood of a person who has recovered from COVID-19 and transfusing them into a patient infected with active coronavirus to help boost the immune system to fight the infection.
AIIMS Director Dr. Randeep Guleria told PTI on Thursday that no clear benefit in mortality from convalescent plasma therapy was seen during a trial conducted among 30 COVID-19 patients. During the trial, one group of patients received convalescent plasma therapy along with standard supportive treatment, while the other group received only standard treatment.
The number of deaths recorded in both groups was equal and there was not much clinical improvement in the patients’ condition, he said.
“However, this is only an interim analysis and we need to do a more detailed evaluation to see if any subgroups may benefit from plasma therapy,” said Dr. Guleria. He also stressed that plasma must be tested for safety and must have enough antibodies to be useful for COVID-19 patients. The efficacy of convalescent plasma therapy in moderate to severe coronavirus infected patients was discussed at the third National Clinical Grand Round (GCR) on COVID-19 held on Wednesday. “Plasma is safe. Regarding its effectiveness, we still do not have a green signal.
Therefore, clinical use must be very judicious and within the scope of national guidelines, ”Dr. Monish Soneja, an additional professor in the AIIMS Department of Medicine, said at the webinar. Convalescent plasma therapy has been listed as an investigational therapy for off-label use in coronavirus-infected patients because there is no conclusive evidence of its efficacy as of yet, Dr. Soneja said.
On the initial findings of the randomized controlled trial, Soneja said, “Convalescent plasma is not a magic bullet.” It can be used particularly in the early moderate stage of the disease. There may be a subset of patients with certain characteristics that can benefit from plasma, he said, adding: “This is a work in progress as we do not know about those characteristics.”
The findings highlight that patients’ relatives should not insist on plasma therapy until the treating physician deems the patient unfit for him and where he may think the mode of treatment would be beneficial, Associate Professor Dr. Neeraj Nischal in the department of medicine at AIIMS, he said. He said that even if therapy has a role, then that is in the early stage of the disease.
But for plasma therapy to be effective, the plasma must contain a sufficient amount of neutralizing antibodies against that infection, the doctor said. “This therapy also carries risks such as inadvertent transfer of blood-borne infections and reactions to serum components, including immune reactions such as serum sickness, which can worsen the clinical condition,” said Dr. Nischal.
According to the Clinical Management Protocols for COVID-19 issued by the Union Ministry of Health, off-label convalescent plasma can be considered for COVID-19 patients with moderate disease that do not improve, which means that the requirement oxygen progressively increases, despite steroid use.
The use of off-label convalescent plasma for the treatment of patients with coronavirus in the moderate stage of the disease has been included in “research therapies”. ABO compatibility and cross-matching of donor plasma is a prerequisite when considering convalescent plasma, the Ministry of Health 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 allergy to immunoglobulins. “The dose ranges between 4 and 13 ml/kg, usually a single 200 ml dose administered slowly over no less than two hours,” according to statistics from the Clinical Management Protocol.
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