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of 464 participants (moderately ill COVID-19 patients admitted to hospitals) were enrolled for the study, which has not yet been peer-reviewed and has appeared on medRxiv, a preprint server.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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Shah Rukh Khan, Kajol unveil ‘DDLJ’ sculpture at London’s Leicester Square
London (PTI): Bollywood stars Shah Rukh Khan and Kajol huddled under an umbrella on a rainy Thursday in London to unveil their bronze likeness from an iconic ‘Dilwale Dulhania Le Jayenge’ scene.
The sculpture of the duo joins Leicester Square’s ‘Scenes in the Square’ trail depicting memorable shots from some of the world’s most famous films, with ‘DDLJ’ marking a Bollywood first and the 30th anniversary of the 1995 box-office hit. It is in this popular London square that SRK as Raj and Kajol as Simran first cross paths unknowingly.
“DDLJ was made with a pure heart. We wanted to tell a story about love, how it can bridge barriers and how the world would be a better place if it had a lot of love in it, and I think this is why 'DDLJ' has had a lasting impact for over 30 years now," said Khan.
“Personally, 'DDLJ' is part of my identity, and it is humbling to see film, and Kajol and me, receiving so much love since it was released,” he said.
He expressed his gratitude to the Heart of London Business Alliance, behind the cinematic trail at Leicester Square, for celebrating ‘DDLJ’ and “immortalising” its lead stars.
“Seeing ‘DDLJ’ become the first Indian film to be honoured in the iconic Scenes in the Square trail is an emotional moment and has brought back so many memories.
"I feel immense pride knowing the film has been embraced around the world, and I want to share this moment with the entire cast and crew of ‘DDLJ’, my friend and director Aditya Chopra and the Yash Raj Films family. This is a moment I will never forget,” added Khan.
Kajol, joined by her daughter Nysa and son Yug, posed with Khan in front of the statue as she braved the rain in a green saree.
“It’s incredible to see ‘Dilwale Dulhania Le Jayenge’ continue to receive so much love, even 30 years later. Watching the statue being unveiled in London felt like reliving a piece of our history - a story that has truly travelled across generations,” said Kajol.
“Seeing it find its rightful place in Leicester Square, a location of such enormous significance to ‘DDLJ’, makes this moment even more special. For the film to be honoured in this way in the UK – the first Indian film to receive such recognition – is something that will forever stay in the hearts and minds of all the ‘DDLJ’ fans across the world,” she said.
Their statue, captured in a dancing pose from the hit song ‘Mehndi Laga Ke Rakhna’, joins the likes of Harry Potter, Bridget Jones, Mary Poppins, and Batman in what is dubbed as an ever-growing celebration of movie magic in a square packed with multiplex cinema screens.
“When ‘Dilwale Dulhania Le Jayenge’, DDLJ, was released 30 years ago, the film became a defining moment for Indian cinema and changed the face of the industry, capturing the hearts of everyone who saw it all over the globe," said Akshaye Widhani, CEO of Yash Raj Films.
“We’re thrilled to be the first Indian film to be represented in ‘Scenes in the Square’. It also marks 30 years of DDLJ, a film that has spread love and joy globally, and shows the cultural impact it has had in UK.
“We are honoured that our superstars and our film are being recognised on the world stage alongside the Hollywood elite, from Gene Kelly to Laurel & Hardy to Harry Potter. This statue will be a great way to express the international appeal of Indian movies and build bridges amongst communities through cinema,” he said.
Since its release in 1995, ‘DDLJ’ has become the longest-running film in Hindi cinema history.
Ros Morgan, Chief Executive at Heart of London Business Alliance, said: “We’re proud to welcome global megastars Shah Rukh Khan and Kajol to our Scenes in the Square trail.
"Dilwale Dulhania Le Jayenge is a cinematic phenomenon that has shaped generations, and London’s first tribute to Indian cinema honours a story whose magic continues to captivate audiences worldwide.”
It is a particularly special year for the film, with a musical based on the romance playing to packed houses at Manchester’s Opera House earlier this year. Aditya Chopra reprised his role as director of the English language stage production, ‘Come Fall In Love – The DDLJ Musical’, which revolved around the love story of Simran and Roger.
The script was a nod to the original as it followed Simran as a young British Indian woman who finds herself engaged to a family friend in India in an arranged marriage. However, the plot thickens when she falls in love with a British man named Roger.
