Plasma therapy not beneficial in reducing mortality or progression to severe COVID-19: Study
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of 464 participants (moderately ill COVID-19 patients admitted to hospitals) were enrolled for the study, which has not yet been peer-reviewed and has appeared on medRxiv, a preprint server.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.
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Zubeen Garg's drowning in Singapore highlights vessel operators' responsibility: legal experts
Singapore (PTI): The drowning of Indian singer-composer Zubeen Garg has brought the spotlight on rules and regulations that concern responsibilities of vessel operators when dealing with intoxicated passengers, according to a media report that cited legal experts.
A cultural icon in India’s northeastern region, 52-year-old Garg travelled to Singapore in September 2025 to perform at a live event. A day before his performance, he went on a yacht trip with a group of people. He drowned while swimming in the sea near Lazarus Island, which is a popular diving spot.
His death shook his home state Assam, where millions came out on the streets mourning. Later, police cases were registered against the organiser of the event, his manager and some others.
Nico Lee, managing director of the Triangle Legal law firm, told The Straits Times that Singapore has Maritime and Port Authority of Singapore (Port) Regulations under which there are provisions to debar drunk passengers.
The owner, agent or captain of the vessel must not allow persons under the influence of alcohol or drugs onboard if they are intoxicated to a point where they endanger safety of the vessel, its crew or any person in it.
“In terms of civil liability, it could be argued that a yacht captain is negligent, as he owes a prima facie duty of care to guests on board under general negligence principles,” Lee was quoted as saying by the newspaper.
The singer and his entourage of about 15 individuals were partying on a chartered vessel, which they had boarded at Marina at Keppel Bay.
A death certificate issued by the Singapore General Hospital listed his cause of death as drowning.
An autopsy report suggested that Garg had 333 mg of alcohol per 100 ml of blood in his system, which was four times the legal limit for driving in Singapore and is likely to have impacted his coordination.
Citing Garg’s case, Lee said the circumstances were serious, as the controller of the vessel knew that the guest was intoxicated. Also, he may not have understood or processed a safety briefing for all passengers.
“That combination makes reliance on an ordinary briefing inadequate. If intoxication reaches a level that endangers the safety of the vessel or persons on board, the person in charge should not permit boarding at all,” he said.
According to Lee, the vessel’s operators could also have assigned a crew member to directly supervise him or ensure that he received a one-to-one explanation when he was capable of understanding.
Part of the responsibility could be attributed to the guest if he chose to enter the water and ignore instructions or behave dangerously despite the yacht owner or charterer’s best efforts, Lee said.
Vanessa Sandhu from Clifford Law LLP told The Straits Times that a key question is whether the yacht captain or operator owed a “duty of care” to the passenger and, if so, whether a breach of that duty caused the death.
“A yacht captain and operator generally owe passengers a duty to take reasonable care for their safety while on board, including swimming or water activities. This may include providing safety equipment and issuing appropriate safety instructions,” the daily quoted Sandhu as saying.
“However, the standard of care is an objective one, based on what a reasonable captain or operator would have done in the circumstances. It is not an absolute obligation to prevent all harm,” she said.
During the coroner’s inquiry, the operators of the vessel had said that no one had forced the singer to consume alcohol or enter the water, and that the entire entourage was informed on the yacht about the necessity of wearing life jackets before going for a swim.
A coroner’s inquiry on March 25 ruled Garg’s death as accidental drowning. On April 1, the police said that investigations into the singer's death had concluded, with no evidence of foul play.
However, in Assam, where seven persons were arrested in connection with Garg’s case, and some of them charged with murder, the matter is being heard in the court. All the suspects have denied any wrongdoing.
