Tag: plasma therapy

View: Donating blood is akin to donating new life

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Blood is critical to human existence. The vitality of blood for life must be celebrated throughout the year. Historically and the current pandemic of COVID-19 has reinforced the need for the prioritisation and preparedness for access to blood and its components for the better health of the citizens. It is a life-sustaining medical resource with no viable alternatives. There is a need to imbibe an altruistic mindset towards voluntary blood donation. Annadan (donation of food) nourishes, and netradan (eye donation) allows one to see again, raktdan (blood donation) is a gift of life.

One unit of blood segregated into its various components like plasma and platelets saves three lives. Essential to the functioning of the healthcare system, blood units and their products are required for elective and urgent surgeries. Further, patients suffering from blood disorders like thalassemia and sickle cell disease require frequent blood transfusion for a healthy life.

India has had a perpetual blood shortage. The current pandemic has intensified the crisis as the functioning of blood banks has been impacted due to limited mobility and rising infections. As a society, we are plagued by misinformation and myths that discourage regular voluntary blood donation. Education and sensitisation coupled with a philanthropic mindset are the enablers of a sustained blood supply.

Individuals in the age group of 18-65 years, weighing more than 45 kgs, having normal pulse rate, blood pressure, and a hemoglobin level of 12.5 gm/dl must voluntarily donate blood. Irrespective of gender, it is safe to donate blood multiple times a year. Men can donate once in three months, and women every four months. However, pregnant women can donate blood 12 months post-pregnancy, and lactating women are deferred from blood donation during the lactation period. People with epilepsy, psychiatric disorders, blood disorders, and type-I diabetes are also not permitted to donate blood. Improved cardiovascular health, slowed aging, and reduced cancer risk are some of the health benefits of regular blood donation.

The current pandemic has brought blood donation to a grinding halt and infused fresh doubts in people’s minds. It is imperative to communicate that COVID-19 recovered patients are eligible to donate blood after 28 days. Vaccinated individuals are free to donate blood 14 days post their vaccination as per the Ministry of Health and Family Welfare’s (MoHFW) circular dated 05.05.2021. The fear of contracting COVID-19 during blood donation must be addressed since blood banks are in adherence to guidelines by the Ministry of Health and Family Welfare (MoHFW).

The advancement of medical science has significantly reduced the proportion of transfusion-transmitted infections (TTIs) like HIV, syphilis, and malaria. The WHO mandates four tests for donated blood for antibodies associated with Hepatitis B, Hepatitis C, HIV, and syphilis. Better donor selection and adoption of more sensitive serological tests like nucleic acid testing (NAT) by many blood banks have further bolstered the safety of donors. Further, increased use of technology to collect, process, and store blood units can lower the wastage of collected blood units. Over the years, our blood ecosystem has struggled with wastage of collected units, between 2014-15 and 2016-17, around 3.5 million blood units were discarded.

Apheresis and blood component separation allows for the optimal utilization of blood. Apheresis does not extract whole blood but only the required component from the donor. For example, convalescent plasma from COVID-19 recovered patients is extracted using apheresis. Blood component separation units (BCSU) separate the blood into plasma, platelets, white blood cells, and red blood cells. Here, one unit of blood can benefit multiple patients. For example, malaria patients need administration of platelets; plasma and other components can be used for other medical procedures.

According to a NACO report, only around 51 percent of the blood banks in the country had blood component separation facilities. Given the demand for blood and its products in India, a dire need to equip blood banks with apheresis and BCSUs exists. The recent initiative of the Government of Jharkhand to provide blood banks of six districts with BCSUs will ease the constrictions in blood supply.

COVID-19 has worsened India’s perpetual blood crisis. This is leading to deterioration in health and even loss of lives. Every citizen’s responsibility is to spread awareness about the benefits of blood donation, bust myths, and lead by example through regular non-remunerative voluntary blood donation.

—The author, Dr. S. S. Sukumar is Chairman, IMA Standing Committee for Blood Donation, IMA H.Q, New Delhi. Views expressed are personal

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Why ICMR dropped plasma therapy from COVID-19 treatment protocol

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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The government on Monday removed off-label convalescent plasma therapy from clinical management protocol for COVID-19 patients as it was not found beneficial in reducing the progression to severe disease or death.

In a meeting last week, all the members of ICMR-National Task Force for COVID-19 were of the view to remove the use of plasma therapy from the guidelines due to its ineffectiveness and inappropriate use in several cases.

What is plasma therapy?

Convalescent plasma therapy is the clinical practice of using blood from patients who have recovered from their illness to help other patients recover faster.

Plasma is the component of our blood that is left when we remove red blood cells from it.

For COVID-19, patients who had recovered from the disease could donate their plasma as it would contain antibodies for the virus. These antibodies could theoretically be then used to boost people’s ability to fight COVID-19 by increasing their immune response

Why it is dropped now?

The first reason for convalescent plasma therapy to be dropped from the guidelines for the treatment of COVID-19 is that it was found by ICMR to not be effective in reducing the progression of symptoms to severe conditions or even death.

The effectiveness of plasma therapy was put into question last year after an ICMR trial called the PLACID trial had tested the effectiveness of convalescent plasma therapy on 400 patients and found no significant benefit of the same.

Recently, the medical journal The Lancet also reported findings from a different double-blind trial on 5,000 patients from the United Kingdom with the same results.

What are the other risks?

Some public health experts have also been cautioning against the rampant use of off-label convalescent plasma therapy calling it “irrational and non-scientific”.

These experts pointed out that there is some very early research that points to the development of variants with mutations that have lower susceptibility to neutralise antibodies in immunosuppressed people who are given plasma therapy.

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Govt drops plasma therapy from COVID-19 management guidelines

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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The government on Monday revised the clinical guidance for COVID-19 treatment, dropping the off-label use of convalescent plasma as it was found not beneficial in reducing the progression to severe disease or death.

The development came following a meeting of the ICMR-National Task Force for COVID-19 last week wherein all members were in favour of removing the use of convalescent plasma from the guidelines citing its ineffectiveness and inappropriate use in several cases.

An Indian Council of Medical Research (ICMR) official said the task force “revised” the Clinical Guidance for Management of Adult COVID-19 Patients and “dropped convalescent plasma (off label)”. The previous guidelines recommended off-label use of plasma therapy at the stage of early moderate disease, that is, within seven days of the onset of symptoms and if there is availability of a high titre donor plasma.

The decision to remove it from the guidelines comes in the backdrop of some clinicians and scientists writing to Principal Scientific Advisor K VijayRaghavan cautioning against the “irrational and non-scientific use” of convalescent plasma for COVID-19 in the country. In the letter, which was also marked to ICMR chief Balram Bhargava and AIIMS Director Randeep Guleria, public health professionals alleged that the current guidelines on plasma therapy are not based on existing evidence and pointed out some very early evidence that indicates a possible association between emergence of variants with lower susceptibility to neutralising antibodies in immunosuppressed” people given plasma therapy.

This raises the possibility of more virulent strains developing due to irrational use of plasma therapy which can fuel the pandemic, according to the letter signed by vaccinologist Gagandeep Kang, surgeon Pramesh C S and others. “We are writing to you as concerned clinicians, public health professionals and scientists from India about the irrational and non- scientific use of convalescent plasma for COVID-19 in the country.

“This has stemmed from guidelines issued by government agencies, and we request your urgent intervention to address the issue which can prevent harassment of COVID-19 patients, their families, their clinicians and COVID-19 survivors, said the letter. “The current research evidence unanimously indicates that there is no benefit offered by convalescent plasma for treatment of COVID-19. However, it continues to be prescribed rampantly in hospitals across India, the letter said.

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Plasma therapy not effective, likely to be dropped from clinical management guidelines on COVID-19

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Plasma therapy on COVID-19 patients has not been found effective in reducing the progression to severe disease or death and is likely to be dropped from the clinical management guidelines, sources said. In a meeting of the ICMR-National Task Force for COVID-19 on Friday, all members were in favour of removing the use of convalescent plasma from the Clinical Guidance for Management of Adult COVID-19 Patients citing its ineffectiveness and inappropriate use in several cases, they said.

The Indian Council of Medical Research (ICMR) will issue an advisory on the matter soon, they said. The present guidelines allows “off label” use of plasma therapy at the stage of early moderate disease, that is, within seven days of the onset of symptoms and if there is availability of a high titre donor plasma.

The decision to remove it from the guidelines comes in the backdrop of some clinicians and scientists writing to Principal Scientific Advisor K VijayRaghavan cautioning against the “irrational and non-scientific use” of convalescent plasma for COVID-19 in the country. In the letter, which was also marked to ICMR chief Balram Bhargava and AIIMS Director Randeep Guleria, public health professionals alleged that the current guidelines on plasma therapy are not based on existing evidence and pointed out some very early evidence that indicates a possible association between emergence of variants with lower susceptibility to neutralising antibodies in immunosuppressed” people given plasma therapy.

This raises the possibility of more virulent strains developing due to irrational use of plasma therapy which can fuel the pandemic, according to the letter signed by vaccinologist Gagandeep Kang, surgeon Pramesh C S and others. “We are writing to you as concerned clinicians, public health professionals and scientists from India about the irrational and non- scientific use of convalescent plasma for COVID-19 in the country.

“This has stemmed from guidelines issued by government agencies, and we request your urgent intervention to address the issue which can prevent harassment of COVID-19 patients, their families, their clinicians and COVID-19 survivors, said the letter. “The current research evidence unanimously indicates that there is no benefit offered by convalescent plasma for treatment of COVID-19. However, it continues to be prescribed rampantly in hospitals across India, the letter said.

Families of patients run from pillar-to-post for getting plasma, which is in short supply. The desperation of patients and their families is understandable because they like to try the best for their loved ones, when a doctor has prescribed this, the public health professionals said. In the plasma therapy, antibodies from the blood of a patient who has recovered from COVID-19 are used to treat serious patients.

They said ICMR guidelines are not based on the existing evidence. They cited the ICMR-PLACID trial which was the world”s first randomised controlled trial on convalescent plasma in 39 public and private hospitals across India.

It found “convalescent plasma was not associated with a reduction in progression to severe COVID-19 or all-cause mortality. This trial has high generalisability and approximates convalescent plasma use in real life settings with limited laboratory capacity”. The large trial of 11,588 patients found no difference in death or proportion of patients discharged from hospital, the clinicians said.

Even for those patients who were not on ventilation initially, there was no difference “in the proportion meeting the composite endpoint of progression to invasive mechanical ventilation or death”, they pointed out. The health professionals added that the PlasmAr trial in Argentina concluded that there is no significant difference in clinical status or overall mortality between patients treated with convalescent plasma and those who received placebo.

“Current research evidence unanimously indicates that there is no benefit offered by convalescent plasma for treatment of COVID-19. However, it continues to be prescribed rampantly in hospitals across India,” they said.

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India considering to remove plasma therapy from national COVID-19 treatment guidelines

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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In what could leave a huge gap in COVID-19 investigational therapies, the Indian Council of Medical Research (ICMR) and the national task force is considering to delete convalescent plasma therapy from its national COVID-19 treatment protocol guidelines. The decision, if taken, will be based on clinical trials conducted by ICMR that showed plasma therapy did not reduce COVID-19 mortality or disease progression.

Convalescent plasma therapy at present is listed as “off-label” use and as an investigational therapy in national guidelines.

In a press briefing, Director General of ICMR Dr Balram Bhargava said, “We have done a large clinical trial on plasma, it will be published in the British Journal. Discussing within the task force on may be deleting plasma therapy from our national covid19 treatment guidelines.”

ICMR’s PLACID (Plasma Convalescent India) trial, the first and largest randomised control trial in the world, released a pre-print of results in early September. The trial with 464 hospitalised patients with moderate COVID-19 symptoms across 39 hospitals showed plasma therapy had no benefit in reducing mortality in moderate to severe cases of COVID-19.

Plasma therapy did not arrest progression of COVID-19 from moderate to severe. However, some patients saw symptoms reduced and improved oxygenation saturation and faster viral clearance in patients who received plasma therapy.

The move holds significance, particularly after WHO trials — in which India was a participant — showed that another potential treatment Remdesivir, was not effective in reducing mortality or hospital stay. ICMR is also “debating and discussing the use of Remdesivir and will take the results of these trials into consideration”.

In June, the Health Ministry had recommended off-label use of plasma therapy for only those COVID-19 patients who showed no improvement despite receiving standard treatment.

While the Centre had held that plasma therapy is experimental, and “illegal” unless it is administered in a facility that was part of the ICMR study, the therapy has seen a widespread acceptance.

Delhi and Maharashtra — two states that saw large numbers of COVID-19 cases — have taken to plasma therapy in a big way. Both states have been conducting multiple trials, setting up plasma banks and promoting donation of plasma from recovered patients.

However, doctors are divided on the therapy. Some medical professionals have questioned the need for a costly plasma therapy, which is proven to not benefit patients. Moreover, reports suggest that family members of COVID-19 positive patients have been running from pillar to post to arrange for plasma from recovered patients.

Nonetheless, some have pointed out that the Delhi government’s phase 1 trials on plasma showed results similar to ICMR’s trials, where therapy reduced oxygen requirement in patients and the duration where they remained breathless was reduced.

After complaints of rampant usage, mostly in mid-tier towns, the central health ministry had in August directed private hospitals to not use experimental therapies such as convalescent plasma or Remdesivir routinely for treating COVID-19 patients.

ICMR is now working on developing horse sera containing antibodies against the Sars-Cov2 virus as a potential treatment for COVID-19. It is partnering with Hyderabad based Biological E and has completed animal trials with horse sera, human trials are under approval stage.

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Plasma therapy not beneficial in reducing mortality or progression to severe COVID-19: Study

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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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.

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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.

Also, catch all the latest updates and trends on the novel coronavirus with CNBCTV18’s blog.

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Make tocilizumab, plasma therapy available for every COVID-19 patient: Gehlot to officials

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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Rajasthan Chief Minister Ashok Gehlot on Sunday directed officials to make available life-saving tocilizumab injection and plasma therapy to every COVID-19 patient in critical condition.

In a review meeting on the coronavirus situation in the state, he said that tocilizumab injection costs around Rs 40,000 and is out of reach for poor and the state government will immediately approve funds for making the drug available for all.

Gehlot directed officials to ensure availability of plasma and life-saving injections as per requirement in all medical colleges and district hospitals of the state along with the SMS hospital. The Chief Minister directed to promote plasma therapy in the treatment of coronavirus and to organise a plasma donation camp across the state.

Those who have recovered from coronavirus should be encouraged to donate plasma keeping health protocol in mind, the chief minister said. “Make such an arrangement that the plasma needed for therapy should be present in our bank. For this, awareness campaigns and donation camps should be set up,” Gehlot said.

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It was informed in the meeting that plasma therapy has started in Jaipur, Jodhpur and Kota.Gehlot said that the state government has increased COVID-19 testing capacity and there should not be no delay in getting test results.

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New online platform to aid COVID-19 patients in need of donors for convalescent plasma therapy

KV Prasad Jun 13, 2022, 06:35 AM IST (Published)

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The COVID-19 continues to wreak havoc around the world with more than 12.7 million cases and increasing. While multiple options are being tried to fight the coronavirus, transfusions with convalescent plasma, one of the traditional methods used to fight infectious diseases, has emerged as one of the effective methods to treat COVID-19 patients. With that said, the success of convalescent plasma therapy is yet to scale heights as there is a dearth of plasma donors willing to donate.

To address the issue and make life easier for patients in need of plasma therapy, Pint (Plasma In Need For Transfusion) Network, one of its kind start-up in the medical field, has come up with an online plasma matching platform which facilitates patients in need of convalescent plasma to find and match with donors, quicker and more efficiently.

The Pint Network is a first self-funded digital initiative of 22-year-old Karina Thakrar and 23-year-old Doctor Neil Pinto. While Thakrar is a graduate in Economics and Sociology from the Loyola Marymount University, Dr Pinto is a graduate from Sion Hospital in Mumbai.

Working on an algorithm of matchmaking, Pint Network, from across India, matches donors with patients based on their blood donation and convalescent plasma donation criteria.

“We have been receiving a lot of calls and forwards from families of patients in critical condition in need of plasma. It was taking days for families to find a single donor and by the time they did, the patient’s condition had already worsened. We wanted to speed up this process in any way we could and building this platform seemed like the best solution within the confines of a lockdown,” said Dr Pinto.

Launched on July 6, this online plasma matching platform has been able to register over 50 donors and COVID-19 patients on its website within a week. It is also in talks with two hospitals at present in order to promote the initiative and reach out to maximum possible donors and patients in need.

“We are collaborating with hospitals across India to increase awareness about the convalescent plasma therapy, especially in the top eight cities where the spread of the virus is maximum,” said Dr Pinto.

Thakrar said that as Pint is a non-profit initiative, it aims at being the facilitator in making resources easily available for the patients battling the disease. “If tomorrow the patient requires plasma therapy, we want to be able to find him a donor at the click of a button. Having said that, it is important that people who have recovered to fight the fear and stigma built around plasma donation and in turn become warriors by helping other patients recover,” she added.

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