New Delhi: Use of convalescent plasma therapy in coronavirus-infected patients does not help in reducing mortality or progression to severe COVID-19, a multi-centric study funded by the Indian Council of Medical Research (ICMR) has found.
The 'open-label parallel-arm phase II multicentre randomized controlled trial' (PLACID Trial) was conducted across 39 public and private hospitals across India between April 22 to July 14 to investigate the effectiveness of convalescent plasma (CP) for the treatment of COVID-19, it said.
The convalescent plasma (CP) therapy involves taking antibodies from the blood of a person who has recovered from COVID-19 and transfusing those antibodies into an active coronavirus patient to help kickstart the immune system to fight the infection.
A total of 464 participants (moderately ill COVID-19 patients admitted to hospitals) were enrolled for the study, which has not yet been peer-reviewed and has appeared on medRxiv, a preprint server.
The National Task Force for COVID-19, a committee formed by the ICMR to respond to the pandemic, has reviewed and approved this study, it said.
The Clinical Management Protocols for COVID-19 issued by the Union Health Ministry on June 27 allowed use of convalescent plasma (Off label) for treating coronavirus-infected patients in moderate stage of the illness under "investigational therapies"
This authorisation has been paralleled by questionable practices such as calls for donors on social media, and the sale of CP on the black market with exorbitant price tags in India, the study said.
Additionally, although CP is a safe therapeutic modality, plasmapheresis, plasma storage and NAb measurement are all resource-intensive processes, with a limited number of institutes in the country having the capacity to undertake these activities in a quality-assured manner.
"The CP was not associated with reduction in mortality or progression to severe COVID-19," the study said, adding this trial has high generalisability and approximates real-life setting of CP therapy in settings with limited laboratory capacity.
A prior measurement of neutralising antibody titres in donors and participants may further clarify the role of CP in management of COVID-19, it said.
The study trial included 464 moderately ill coronavirus infected hospitalised patients, of whom 235 were given convalescent plasma along with best of standard care while 229 received only standard care, as per the study.
Those in the intervention arm received two doses of 200 ml of CP, transfused 24 hours apart, in addition to the BSC (best standard of care). The two plasma units were collected preferably from different donors depending on the availability and ABO compatibility to increase chances of receiving CP with NAb, it said.
"The PLACID trial results indicate that there was no difference in 28-day mortality or progression to severe disease among moderately ill COVID-19 patients treated with CP along with BSC compared to BSC alone," the study said.
The central implementation team at the ICMR was responsible for study design, study coordination, data analysis, data interpretation and writing of the report, the study stated.
Patient enrolment, data collection and actual conduct of the study was done at public and private hospitals independently and the investigators in the ICMR had no role in it, it added.
Convalescent plasma (CP) as a passive source of neutralising antibodies and immunomodulators is a century-old therapeutic option used for the management of viral diseases.
According to the study, only two randomised controlled trials on CP use in COVID-19 have been published, one from China and the other from the Netherlands.
Both were halted prematurely, the China study due to inadequate patient enrolment and the one from the Netherlands due to a need to redesign the trial based on interim findings.
In both studies, no mortality benefit was noted, and the Dutch study raised uncertainties regarding pre-transfusion antibody-status of patients as a potential factor in identifying appropriate candidates for CP therapy.
This uncertainty in the published evidence is reflected in a recent systematic review, which remained undecided on both the safety and effectiveness of CP as a therapeutic option in hospitalized patients of COVID-19.
Meanwhile, CP therapy has received regulatory approval for use in patients in different countries. This has resulted in its widespread adoption in real-world clinical practice, where it is being used to treat COVID-19 patients with a wide spectrum of disease severity.
"Given these uncertainties, we undertook the current study to determine the effectiveness of using CP in moderately ill COVID-19 patients admitted to hospitals across India in limiting progression to severe disease and determine the associated short-term adverse effects," the study said.
All participants or their family members or legally authorised representatives were provided with information regarding the trial in a language they were comfortable with, and written informed consent was obtained prior to participant recruitment, it said.
Let the Truth be known. If you read VB and like VB, please be a VB Supporter and Help us deliver the Truth to one and all.
Dubai: Putting up a stout defence, iconic Sunil Gavaskar on Friday said neither he blamed Virat Kohli's actor-wife Anushka Sharma for India captain's failure nor he made any sexist remarks during an IPL match and his comments were being misinterpreted.
Kohli had a bad day in office on Thursday when he led Royal Challengers Bangalore against Kings XI Punjab. He dropped two catches of rival skipper KL Rahul and managed only a run off five balls in RCB's chase.
While Kohli was still at crease, Gavaskar said India captain is keen to improve and he knows that he can do so only by practicing more and more. He then added that during the lockdown Kohli faced only Anushka's bowling and it is showing that it did not help much.
Gavaskar was speaking in Hindi when he made the comment.
However, the comment did not go down well with Kohli and Anushka's fans and some even demanded his sacking from Star Sports commentary panel, lashing out at him on social media.
Reacting to it, Anushka also issued a statement on her Instagram page and said that Gavaskar's message was "distasteful".
Gavaskar though said his comments were not understood in right context.
The remark according to Gavaskar was in reference to a video clip where Kohli and Anushka were seen enjoying some tennis ball cricket in their compound.
"Firstly, I would like to say, where am I blaming her, I'm not blaming her. I am only saying that the video showed she was bowling to Virat. Virat has only played that much bowling in this lockdown period," Gavaskar told India Today channel.
"It is tennis ball fun game that people have to pass time during the lockdown, so that's all, so where am I blaming her for Virat's failures."
Gavaskar also rubbished allegations on social media that he made a "sexist comment".
"I'm the one who has always batted for wives going with husbands on tours. I am the one who has always said that like a normal guy going to office for a 9-5 job, when he comes back home, he comes back to his wife, similarly why can't cricketers have their wives with them," Gavaskar said.
He also tried to explain his comment.
"As you can hear from the commentary, Aakash was talking about the fact there has been very little chance for any proper practice in the lockdown, for everybody...
"That has actually shown in rustiness of some of the players in their first matches. Rohit (Sharma) didn't strike the ball well, now in the second match he has got runs, MSD (Mahendra Singh Dhoni) didn't strike the ball well in the first match."
He then also explained what exactly he said.
"Anushka was bowling to him, so that's what I said, that's the only bowling, I have not used any other word. She was bowling to him, that's all, where am I blaming her, where I am being sexist in this."
"I'm just only stating what was seen on the video which was maybe recorded by somebody in the neighbouring buildings and put up and that's the only thing I'm doing, but the point I'm making trying to make is that there was no practice for anybody including Virat in the lockdown.
"I have not been sexist, if somebody has interpreted it, what can I do," Gavaskar said.