Plasma therapy helps stabilise Covid patients, shows trial at Lok Nayak
Of the 29 Covid-19 patients enrolled for the trial at Lok Nayak, 14 were given convalescent plasma from other recovered patients and 15 were administered fresh frozen plasma without any therapeutic benefit.Updated: Jun 30, 2020 03:36 IST
Plasma therapy has helped in stabilising the respiratory rate, improving oxygen saturation and reducing chances of organ failure in ICU patients of the coronavirus disease, showed the results from a small trial conducted at Delhi’s Lok Nayak Hospital, according to chief minister Arvind Kejriwal’s office on Monday.
The data reinforces the promise of plasma therapy, a process in which blood rich in antibodies from a Covid-19 recovered patient is transfused into the body of someone still struggling with the virus, in helping avert deaths due to the viral disease. Kejriwal on Monday announced the Capital will soon have a dedicated bank to pool in plasma from recovered patients.
Of the 29 Covid-19 patients enrolled for the trial at Lok Nayak, 14 were given convalescent plasma from other recovered patients and 15 were administered fresh frozen plasma without any therapeutic benefit.
The initial results show that respiratory rate came down, oxygen saturation improved and their sequential organ failure assessment (SOFA) score, a yardstick that predicts ICU mortality, also improved in the patients who were given convalescent plasma.
The average respiratory rate of the patients selected for the trial was just over 35 (normal is 12 to 20 breaths per minute), which reduced to about 27 breaths in 48 hours, and was closer to the normal 20 in seven days. This was much better than those who were given the plasma without therapeutic benefit.
Similarly, the oxygen saturation went up by 6.6 percentage points within 48 hours and 9.9% in seven days in patients given convalescent plasma. The SOFA score came down by 1.8 in patients given convalescent plasma as opposed to 0.6 in those in the control group within 48 hours. This score reduced by 4.5 in patients given convalescent plasma as opposed to 3.7 in the other group. Higher the score the likelier it is that a person will die.
Duration of ICU stay as well as hospital stay was also less in patients who were given convalescent plasma.
Lok Nayak hospital was the first to receive a nod for plasma therapy trial in India.
“The findings of the trial are yet to be published. However, preliminary evidence shows that it improves the oxygen saturation and reduces organ failure scores in patients if administered at the right time. This might improve mortality rates, however, none of the studies globally have proved survival benefits so far. Plasma therapy remains one of the most potentially beneficial treatments for Covid-19 if given at the right time,” said Dr SK Sarin, director of Institute of Liver and Biliary Sciences, which partnered with Lok Nayak hospital for the trial.
Before announcing the setting up of a plasma bank, Kejriwal had last week described plasma therapy as one of the five weapons that Delhi has in its fight against coronavirus disease (Covid-19). The plasma bank – which will operate largely like a blood bank – will be set up in the Institute of Liver and Biliary Sciences (ILBS) hospital in south Delhi.
When the condition of Delhi health minister Satyendar Jain started deteriorating, he too was administered the therapy. He has now recovered from the infection.
Currently, plasma therapy is an experimental treatment that the government has allowed only in moderately ill patients whose oxygen requirement does not go down despite providing oxygen support and steroids.
International studies so far have shown that the therapy is safe, with less than 1% adverse outcomes such as transfusion reactions, in a study of 20,000 patients who received the therapy in the US, according to Mayo Clinic Proceedings.
However, it does not establish the efficacy of the therapy. Another study of 10 patients published in the Proceedings of the National Academy of Sciences from China showed that plasma therapy may lower severity of disease, aid recovery of liver and lung function, and reduce inflammation.
“If plasma therapy is administered at the replicative stage, it can neutralise some of the virus and prevent the disease from progressing onto critical stages. It should preferably be given before a person reaches a stage where they have to be put on a ventilator. If organ failure has already started or the lungs have been damaged, then the therapy may not be very helpful,” Sarin said.
At Max hospital, which was the first to actually administer the therapy, 50 people have received it under the multi-centre clinical trial being spearheaded by the Indian Council of Medical Research (ICMR).
In this, patient parameters – such as the complications, number of days spent on the ventilator, oxygen requirement -- is compared to a control group that did not receive plasma therapy. “However, the revised clinical guidelines by the health ministry in mid-June has allowed the use of the therapy to the particular category of patients even without registering for the clinical trials. About 15 or so patients have received the therapy outside of the trial,” said Dr Sandeep Budhiraja, group medical director, Max Healthcare.
The therapy is also not effective in people who already have a high level of antibody. “When the infection enters a person’s system, they start developing the antibodies against it too. I think we are the only hospital to test the antibody level of the recipient along with that of the donor. If a person already has high levels of antibodies (more than 641), then adding more antibodies to it may not be helpful,” said Dr Sarin.
Across India, 321,735 people have recovered from the infection, and over 50,000 in Delhi alone, as on Sunday. However, getting a plasma donor is still a challenge for many with social media and WhatsApp becoming their last resort to find a donor.
This has also led to scams such as the one where 23-year-old man who duped Delhi assembly speaker Ram Niwas Goel and a friend who were looking for a plasma donor. A man claiming to be a doctor from city’s government hospital agreed to donate plasma but asked for cab fare. The man stopped returning his calls afterwards.
Kejriwal on Monday said the bank will streamline the plasma therapy system in the city. He said the government is working out on the modalities of the plasma bank and they will be finalised in the next two days.
Meanwhile, hospitals are doing their best to motivate patients who have been discharged to come back and donate plasma to help others.
“We counsel all Covid-19 patients at the time of discharge to come back in two weeks to donate plasma. We keep a record of these patients and call them when someone is in need of plasma. However, we do not get enough donations at the moment to let us create a bank for convalescent plasma. The patients also reach out on social media, there are various organisations that have stepped in to help as well. But there is a gap in demand and supply. For example, one website that connects donors and recipients received requests for plasma from 700 people and only 150 willing donors in a week. And, only 50 of the 150 were eligible to donate after screening,” said Dr Budhiraja.
Finding the patient’s blood type in stock is also a challenge, said Dr Sushma Bhatnagar, head of the Covid-19 services at AIIMS, Jhajjar. “We do have some donor plasma in our blood bank; but we do not always find the patient’s blood type in stock. What we do then is start calling the patients who have recovered from the hospital and ask them to come and donate the plasma. I think, counselling the patients has an important role to play. If it is done properly at the time of discharge, people are more likely to come back,” said Dr Bhatnagar.
The Delhi government created a bank of about 200 samples, but finds it tough to replenish it.
“Collecting plasma from those who have recovered remains a challenge, with them not wanting to come back to hospitals. So, it is essential that we take the technology to them. Just like blood donation drives, the government can conduct plasma collection drives in the containment areas where many cases are being reported. A plasmapheresis machine (a device that takes blood out of the body, separates the components, and reinfuses components other than plasma back into the body) can easily be carried in a van or stationed at a dispensary for the collection,” said Sr Sarin.