India pushes ahead with clinical trial of ‘very promising’ blood plasma treatment for coronavirus

Countries race to test safety and effectiveness of experimental treatments already used as last resort in hundreds of seriously ill Covid-19 patients

A lab technician freeze packs donated convalescent plasma donated by recovered Covid-19 patients in Dulles, Virginia (AFP/Getty)

India is starting one of the world’s first clinical trials of experimental blood plasma therapy, described as a “very promising” potential treatment for seriously ill coronavirus patients.

The treatment takes blood donated by someone who has recovered from Covid-19, extracts the colourless plasma rich in antibodies for fighting the disease, and gives this as a transfusion to the infected patient.

It’s a tried and tested technique that has been used as far back as the Spanish flu of 1918 and was more recently approved by the World Health Organisation to combat the outbreak of Ebola in west Africa.

But the hour-long procedure comes with its own risks, including the potential to pass on other illnesses from the donor to the patient, and it is not yet known how effective it will be when it comes to the new coronavirus.

None the less, medical teams across the world have been taking donations from recovered coronavirus patients and are already using plasma therapy as a last-ditch treatment, with consent, in emergency cases – what’s known as compassionate use.

It’s a rare instance where scientists are having to play catch-up with the reality on the ground. The nature of the pandemic means doctors need to apply new treatments “with rigour but also with unprecedented speed”, said Dr Vishal Rao, who is leading India’s phase-one trial at Victoria Hospital in Bengaluru (formerly Bangalore), Karnataka.

Dr Rao told The Independent that he already has several donors and expects the first patients in the trial to start receiving transfusions by the end of this week.

Simultaneous phase-one trials are being conducted by the University of Chicago and Semmelweis University in Hungary. Using a small number of patients in a controlled environment, their job is to establish the safety of the procedure so that larger phase-two trials, with hundreds of patients, can then begin.

After media coverage of apparently successful plasma therapy treatments in compassionate use cases in several Indian states, Dr Rao said the authorities had receiving “thousands” of requests from hospitals across the country to start using the experimental technique.

The Indian health ministry joint secretary Lav Agarwal was forced to issue a statement this week stressing that “currently there are no approved therapies for Covid-19, including plasma therapy”, and that “while plasma therapy is one of the treatments that is currently being experimented with, there is, however, no evidence to support it as a treatment”.

Dr Rao said he welcomed the government’s statement, saying it was not feasible to roll out plasma therapy before the safety trials have been completed. But he also supports its use on compassionate grounds “if somebody is willing to take the risk”.

“What we’ve seen is that the gap between research and clinical practice, the gap between bench and bedside has narrowed down significantly in this time of pandemic,” he said. “It has come down from years to weeks and months. The initial data [from compassionate use] is a very, very promising start.

“We don’t have the liberty of time to look at a very large, statistically significant number and then debate all of these issues. This is something that the global community is trying to answer in a very quick fashion… We will really have to push science to the limit of its utility.”

The Indian Council for Medical Research has already approved plans for a phase-two trial involving more than 450 patients that, if the Karnataka trial goes well, will take up to six months.

The US gave the green light for a similar phase-two trial, also randomised and controlled and also involving 450 test subjects, a week ago. And American researchers are also following the progress of more than 600 patients who have received compassionate plasma therapy. Doctors say such cases, though not carried out in the rigorous setting of a medical trial, could provide useful insights.

The first paper describing the apparently positive results from experimental plasma therapy in 10 severely ill coronavirus patients was published as a “preprint” – before going through a peer-review process – by a Chinese team in Wuhan on 16 March.

A second study, involving five critical patients in Shenzhen, China, was again issued as a preprint in the Journal of the American Medical Association on 27 March.

Five people who had been in hospital in Shenzhen for at least 10 days were started on transfusions, the paper says, and within three days body temperature had normalised in four out of the five patients. At the conclusion of the observations, three had been discharged from hospital and two were in a stable condition.

The authors said that “in this preliminary uncontrolled [study], administration of convalescent plasma containing neutralising antibody was followed by improvement in clinical status”. They also stressed, however, that “the limited sample size and study design preclude a definitive statement about the potential effectiveness of this treatment”.

German authorities approved the country’s first plasma therapies on 7 April, while France started giving treatments to 60 patients across Paris hospitals around the same time.

The UK has only just approved a trial which officials say could eventually lead to treatment of up to 5,000 patients a week, but has yet to get off the ground. England’s deputy chief medical officer Jonathan Van Tam said Britain was “leading the world’s largest trials to find a treatment for Covid-19, with over 7,000 people so far involved testing a range of medicines”, adding: ”We hope to add convalescent plasma to this list shortly.”

Dr Rao said that in a global crisis, no country should sit idly by and “wait for somebody else to solve it for them”. “India is at the forefront, trying to give some quick answers, but each country needs to push its scientific rigour and innovative promise to the limit,” he said. ”[This crisis] needs the global collective brain and collective consciousness to come together to solve it.”