Reuters

Does plasma therapy treat Covid? Is it safe? Here's all you need to know about the approach

There are real dangers in the way plasma therapy has been publicised in the media, particularly in Pakistan.
Updated 14 Apr, 2020 05:00pm

The news every morning is grim. With the number of cases rising exponentially in all countries, the infection rate of Covid-19 (Corona Virus Induced Disease 2019) does not appear to be slowing down. A daily dose of numbers infected in each province with total deaths only adds to the anxiety and uncertainty that has gripped not only our country, but the entire world.

We had been dealing with intermittent outbreaks of polio across the country, had barely recovered from the HIV epidemic in Larkana, and had just about dusted ourselves off (albeit not completely) from a dengue outbreak in Punjab, and here we are now: facing another crisis. Only this time the transmission is unclear, knows no bounds, and it is not quite as simple and easy as spraying your garden to eliminate the vector because it is not a mosquito, it is us.

Covid-19 is new and as aptly referred to, novel. We are still trying to understand it. What makes the virus scarier than many other infectious diseases is that no approved medical treatment exists currently. Moreover, there are no vaccines in the market that will prevent humans from acquiring the infection in the first place.

In the absence of these modalities, healthcare professionals have no other choice but to provide supportive care (which simply manages the symptoms of the disease) to patients afflicted with Covid-19.

How does the virus cause disease?

The virulence of a particular virus is often associated with the immune response it encounters in the human body. For Covid-19, the immune response has been divided into two phases. The initial phase is thought to involve the development of a specific adaptive immune response required to eliminate the virus, and stop progression of the disease. Therefore, it becomes important to provide treatments that boost immune responses early in the infection, such as antibodies and immunomodulators.

Immune responses however tend to weaken with age, which is why the elderly are particularly vulnerable.

If the immune response is weak or impaired because of other comorbidities such as cardiovascular diseases and diabetes, the virus multiplies and can lead to tissue damage. The second phase of the immune response leads to damaged cells inducing inflammation in the lungs.

This is where the infection enters its dangerous phase, since lung inflammation causes life-threatening respiratory disorders, making it difficult for individuals to breathe on their own. Different therapies being tested work at different stages of the disease which is why it is important to identify which phase a patient is in before you initiate treatment.

New therapies

In the face of this pandemic, several new experimental therapies are being proposed and tested by medical researchers, including anti-viral drugs which can kill viruses. Other drugs include immunomodulators that modify the ability of the immune system to fight viruses. Researchers have also looked into medicines used to fight other infections such as the anti-malarial choloroquine, which is thought to help prevent the virus from infecting cells.

Experimental therapies

Many of the therapies being investigated currently are regarded as "experimental" since they have no proven efficacy in fighting off this variant of the coronavirus.

Experimental therapies or treatment are not recommended except in the setting of clinical research. Such treatments, under ideal circumstances, should not be provided to the general public until safety and effectiveness has been established through rigorous systematic research.

However, amidst these desperate times with Covid-19 related deaths increasing every day, the natural inclination is to make use of any novel intervention that provides even the tiniest glimmer of hope.

Plasma therapy: What is it and how does it work?

One such intervention that has been the talk of the town is convalescent serum transfusion, commonly referred to as "plasma therapy". This treatment modality has previously been used as a desperate last resort step during Ebola outbreaks of 2014, and also in the Severe Acute Respiratory Syndrome (Sars) and Middle East Respiratory Syndrome (Mers).

The procedure of plasma therapy involves collecting blood from someone who has recovered from Covid-19 and transfusing separated plasma to a critically sick patient. Plasma is the clear part of blood that is left when blood cells have been removed and contains antibodies and other proteins. The transfusion of plasma with its antibodies provides a form of 'passive immunity' to the sick recipient to fight the infection. The protection offered by passive immunisation however is short-lived, usually lasting only a few weeks or months.

The science behind plasma therapy and passive immunisation, per se, is not new or novel considering that the concept, introduced by a German immunologist Emil von Behring, has existed since 1890, and has been widely applied for the treatment of different infectious diseases including mumps, measles and polio etc.

The donor of the plasma must have been previously diagnosed with laboratory-confirmed Covid-19 and subsequently test negative for Covid-19 and other respiratory viruses, as well as for Hepatitis B virus, Hepatitis C virus, HIV, and syphilis at the time of donation. The donors must be otherwise healthy for at least 10 days, with a high level of Covid-19 specific antibodies.

Will plasma therapy treat Covid-19 patients?

We don’t know. Medical researchers and scientists all over the world are now grappling with this question.

Experience from China

Preliminary data from China is promising, reporting some positive outcomes of convalescent serum transfusions to desperately sick Covid-19 patients. However, there is no robust evidence to consider this as a "miracle cure".

There are multiple reasons for this. First and foremost, one of the studies from China that reported successful outcomes of this experimental therapy involved a small group of critically ill Covid-19 patients. Furthermore, the authors of this research themselves acknowledged several limitations, including the fact that the patients were also on multiple other treatments (including steroids and antiviral agents) and they cannot be sure what helped, given the very small number of patients.

Other researchers have also critiqued this investigation, calling it an "anecdotal case series". This means that the conclusions from the China experience cannot be generalised since they are inconclusive.

Previous research on plasma transfusions used for diseases other than Covid-19 indicate that this procedure is certainly not risk free, and may lead to side effects in recipients, including but not limited to severe allergic reactions, acute lung injury, and circulatory overload in patients with cardiorespiratory disorders.

Current situation of plasma therapy

Plasma therapy may yield promising results in the future but at this point in time, it is imperative to recognise that we are sailing in unchartered waters. Convalescent serum transfusion is an experimental therapy.

Presently, Covid-19 convalescent plasma is either being used as part of a clinical trial (a form of rigorous systematic investigation) or being provided as an Emergency Investigational New Drug (eINDs) to individual patients.

The latter falls within an ethical framework known as Monitored Emergency Use of Unregistered Interventions (MEURI). During the 2018 Ebola outbreak in West Africa, the World Health Organisation (WHO) established a set of criteria for access to investigational therapies for individual patients outside of clinical trials in emergency, life threatening situations.

The first requirement is that it can be used as MEURI if no other treatment exists. This holds true for Covid-19. Another important criterion includes an approval from a qualified scientific advisory committee. This has been done in the case of United States, where the Food and Drug Regulatory Authority (FDA) has approved the use of this therapy for critically ill patients a couple of days back. Approval from an ethics committee is another essential requirement. Within this context, obtaining informed consent from patients who are provided this experimental therapy is necessary. The patients must know that what they are being offered is an experimental therapy which itself can have significant short-term and long-term side effects. Investigators are of course required to document the results and share them in a timely manner with the wider medical and scientific community.

Preliminary reports from MEURI use of plasma will continue to add important information. However, the critical next step is moving to a much more scientific clinical trial design of investigation since this is what is needed to draw conclusive evidence regarding this treatment modality.

Plasma therapy in Pakistan

The technology for using plasma therapy exists in Pakistan, but only at a handful of places. Therefore, wider use across the entire country may not be possible.

There is also an assumption that every convalescent patient will be willing to donate. The media glare and the hype created may actually pressurise recently recovered Covid-19 survivors to feel obliged to donate. This is not like any ordinary blood donation and carries its own risks for the donor. This donation involves taking approximately 400 ml of plasma using a procedure called "apharesis" in which the donor’s blood is passed through a machine to collect plasma, the plasma is extracted and the blood cells returned.

This process may require the insertion of a wide catheter, called a double lumen line, and can take up to two hours. The side effects may include allergic reactions, fatigue, dizziness and nausea etc. While these side effects are usually mild and stop once the procedure ends, it is important that donors are informed about them.

Against this backdrop, it is important keep public expectations in check. There are real dangers in the way plasma therapy has been publicised in the media, particularly within the context of Pakistan.

While providing hope in times of despair is essential to boost morale, it is also the ethical responsibility of the scientific and medical community, as well as the media, to provide full information to the general public.

Regulation of research

Physician-researchers must adhere to proper protocols as they attempt to use this experimental therapy within Pakistan. This requires scientific approval from a regulatory authority which, in this case, includes Drug Regulatory of Pakistan (Drap) and ethical approval from institutional research ethics committees and the National Bioethics Committee (NBC) of Pakistan.

The NBC is providing rapid turnaround reviews of Covid-19 related research proposals within 72 hours in order to ensure that studies can be initiated as quickly as possible while ensuring safety and welfare of patients. Ethical oversight is always essential when human subjects are part of medical experimentation, and this becomes even more important in times of crises when populations are rendered more vulnerable to possible exploitation.

When experimental modes of treatment, such as convalescent therapy are being used, patients and family members must be adequately informed of not only the benefits, but also the possible risks/complications that this therapy may entail. It is imperative that patients and their families are not misled in their understanding of participation in research and realise that this is not proven therapy. Such steps ensure greater transparency and help in maintaining public trust.

Responsibilities of media

Media has a key role in providing relevant and pertinent information to the public, and not create false hypes by claiming convalescent therapy as a miracle.

Caution also needs to be exercised in providing incomplete information to the public without ascertaining all the facts. Research is always done in a certain context. When a researcher reads a research study and looks at the results, she or he will interpret findings based on multiple factors. However, when media accesses the same articles, chasing deadlines, they tend to start putting pieces of the puzzle together that are still missing. The consequence is that an incomplete set of often grossly misleading information is shared with the public.

The pitfalls of doing so were illustrated when the use of the anti-malaria drugs was touted to be a miracle cure for Covid-19 leading to a global shortage for the drug and several fatal and non- fatal toxicity reports.

Amidst a growing crisis, with increasing morbidity and mortality, there is a sense of urgency to do whatever it takes. However, we have a responsibility to adhere to established professional and ethical standards, for the safety of the public.

Scientific research and advancements ought not to be discouraged but in Friar Lawrence's warning to the impulsive Romeo, who represents the voice of reason and caution in Shakespeare's Romeo and Juliet (Act 2, Scene 3), "Wisely and slowly. They stumble that run fast."

We must proceed but wisely so that we do not stumble.


Opinions expressed are those of the authors and not necessarily of the institutions they are employed with.

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Sualeha Shekhani is a senior lecturer at the Centre of Biomedical Ethics and Culture, SIUT. She has an undergraduate degree in Social Sciences and a Masters in Bioethics (MBE).

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Natasha Anwar is Consultant Molecular Pathologist based at the Aga Khan University and Hospital Regional Lab in Lahore, Pakistan. She has a PhD in Molecular Biology of Infectious Diseases, and a Master in Bioethics (MBE).

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Mariam Hassan is a physician-researcher working as a clinical research administrator at Shaukat Khanum Memorial Cancer Hospital and Research Centre. She has an MSc in clinical trials, a Postgraduate Diploma in Bioethics, and is a fellow in the regulatory science and research ethics area.


The views expressed by this writer and commenters below do not necessarily reflect the views and policies of the Dawn Media Group.

Comments (33) Closed

imran
Apr 06, 2020 09:47am
Passive injection of antibodies against corona virus has never been tried before, because Covit-19 never existed before. Passive immunization is a standard treatment for deadly diseases such as Tetanus and Botulism- In Medicine every drug has side effects, and every drug is used only if the benefits of using the drug outweighs its side effect, Convalescent plasma antibodies against corona virus is no exception. There are some studies which show positive benefit as mentioned in this article of using Antibodies against corona virus, and it is being used in latter stage when everything else fails and the lungs have already been damaged --- some suggest that its earlier use may be more useful-- it is correct that it effects are short lived, few days or weeks--- these few days or weeks are crucial for the patient, it gives patient own immune system enough time to respond to corona virus.
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Qureshi
Apr 06, 2020 10:28am
Thank you dawn for educating the masses.
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Nazir Gilani
Apr 06, 2020 10:47am
Not everyone can afford it. Especially at this point.
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Safdar Toor
Apr 06, 2020 10:50am
Excellent explanation of Plasma therapy, its benefits and consequences to convalescent.
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Uza Syed
Apr 06, 2020 10:58am
Very informative and helpful to understand what exactly is going on.
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aj
Apr 06, 2020 11:00am
I agree 100%. I have eluded to this in my program on Such TV sehat Zindagi 4-6 wks ago after listening a surgeon deliberating with confidence on Geo news about such management of such patients. I was shocked how dare such unprofessional behaviour is propagated on such TV programs and shamefully such so called expert from a speciality other than related to such pandemic can be glaring in our eyes and proposing without fear of any consequences and without any research. I did bring the anecdotal studies and reports what i believe this so called expert was getting his information. This is shameful and sad
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Aasim Ahamd
Apr 06, 2020 11:11am
The hype and slogans of 'magic cure' are also true for Hydroxchloroquine as of "Plasma therapy". Research in outbreaks is essential. But the research must be scientifically sound with no short-cuts. Whether it is MEURI or a Randomized Clinical Trial (RCT) as RCT can be done too in specific circumstances, these should be reviewed by an independent Ethics Review Committee, preferably a National committee that does a rapid review without compromising the on ethics.
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Farooq Rathore
Apr 06, 2020 11:18am
This article provides a balanced and academic review of a treatment being promoted as the "Miracle cure" specially in Pakistan. Just this morning a famous celebrity Pathologist from Karachi was live on TV explaining the urgency and need to use this treatment widely and as soon as possible. Desperate times sometimes call for desperate measures but we should not ignore the ethical aspects and scientific research ( which are many a times tossed away ) of such treatments and consider all the pros and cons.
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Dr. Aasim Ahmad
Apr 06, 2020 12:16pm
The hype and call of 'magic cure' is also true for Hydroxychloroquine like the "Plasma Treatment". Hydroxychlooquine is also used for treatment of Systemic Lupus Erythromatosis (SLE) and other autoimmune disease. Unfortunately it is now unavailable as not only individuals but many responsible agencies looking after this epidemic have bought/confiscated the stock. To find cure it is essential that research is done, this research needs to be scientifically valid. New treatments can be discovered by either doing a Randomized Control Trail (RCT) in less severe case or by doing a MEURI (as mentioned in the article). All research then should be reviewed by an independent Research Ethics Committee preferably a national one, that reviews it robustly in a short period of time.
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Sam
Apr 06, 2020 12:33pm
This is a very well written article and explained in simple words the difficult concept. While we hope something, any thing could work for this disease, we should remain realistic. It's dangerous for non medical people to recommend or promote an uproven treatment . Covid 19 kills by causing Acute Respiratory Distress Syndrome, a terminal process that often happens in many conditions and some time even outside range of infections such as severe burns, pancreatitis etc. Plasma has no role in treating ARDS. Perhaps early treatment to slow down the virus before the body goes haywire in response may have a role. Readers quoting use for tetanus and Botulism should know that those are bacterial diseases and work via toxins and not direct cell injury such as virus. Virus are a totally different ball game and can infect even bacteria.
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shahbaz khan
Apr 06, 2020 01:23pm
Whichever medicine you take, there are bundles of side effects mentioned in its manual. It doesn't mean we should stop taking that medicine. Secondly, you haven't provided any proof of your claims. The top doctors in Pakistan and worldwide are saying something else and you claim something else. Please don't destroy the ray of hope people have got atm. Thanks
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Ayaz Ibrahim
Apr 06, 2020 02:01pm
Thanks for a very informative article; better to keep our hopes in check for this plasma technology.
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Layman Zaheer Gilgiti
Apr 06, 2020 03:02pm
I am a layman at biotech. I literally had already througt it out in mind it will be literally impossible to do such a cure using Plsama transfusions. Now I am amazed to see all the risk factors. Aprat from all the risk I had though it would be literally impossible to do plamasa transfusions on such a big scale. How on Earth will somebody could have arranged plama transfusion for growing numbers given it had just a few risks. China would have done it at first go had it been a possible cure. Even they tried and opted not to and told the world be careful. How awfull is it to see out so called doctors on TV have said that this will be certainly be successful at their hands howcome, howcome! I literally fear going to hospitals to a see a Doc!
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Farzana Amir
Apr 06, 2020 03:17pm
Very well written and balanced article, explaining almost all aspect of the trial .I will support for research design according to MEURI . Considering the understanding of our population its important to explain them the risk and benefits and also about the status of research. most of the channels these days are presenting this as "New treatment option".Media always have a louder voice and specially these days when people have nothing but to watch media the message reaches to everyone very rapidly . Creating an impression to use this as treatment option is totally wrong and if anyone is planning to offer such services should be done after writing and propel approval by approved committees otherwise situation can me even worst.
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Dr. Salaria, Aamir Ahmad
Apr 06, 2020 03:37pm
According to the latest press briefing of the White House Coronavirus Task Force consisting of top U.S. infactious diseases experts and doctors in Washington, D.C., there is no doubt that plasma therapy provides a ray of hope to treat coronavirus patients not only in the U.S. but all over the world.
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Badar Zaman
Apr 06, 2020 05:01pm
Thank you Dawn for educating us as always with the support of relevant references and research papers unlike so called vibrant but actually irresponsible electronic media
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M. Saeed
Apr 06, 2020 07:08pm
Plasma therapy is restricted by the donor blood group being suited to the patient.
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Tahir M
Apr 06, 2020 07:27pm
It has been hyped up by media and some Professors as a discovery emanating from research done in Pakistan. Good luck as long as it has potential of being a life saver.
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ALI KHAN
Apr 06, 2020 08:02pm
Excellent written Article proud that Pakistani women have such a talent. World class Article.
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THE MORNING STAR, MD.
Apr 06, 2020 08:31pm
Excellent article. On a very relevant and currently debated topic.
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AB London
Apr 06, 2020 08:41pm
I am not a doctor or a research scientist, but I really hope it does so that we humankind can overcome this deadly Chinese virus
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Shanza agha
Apr 07, 2020 02:11am
Excellent and informative article explaining and giving correct and complete information about the pathology of the disease and plasma therapy. The article also gives valuable information about the history of plasma therapy, its current situation and addresses the hype created by media calling it a “miracle” or “magic” cure. Although convalescent plasma therapy seems to be a “promising” therapy in Corona virus treatment, controlled clinical trials are needed to get definitive answers whether convalescent plasma improves symptoms of COVID-19 or can stop the disease and which people it could help the most. Thank you Dawn and article writers.
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Israr Khan Ismailzai
Apr 07, 2020 03:07am
Something is better than nothing. I don't think that letting someone die and not try something that can have a positive effect on the patient is a smart move. Even if it's for short term, hopefully a vaccine will be available soon.
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anwar chaudhary
Apr 07, 2020 04:22am
Good job ! kids
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jaredlee007
Apr 07, 2020 07:49am
This articles has few key points one of which is that a lot of hype has been associated with Plasma Therapy and media must be held responsible for this type. An impression has been given that if one suffers from COVID-19 then no need to worry, just get Plasma Therapy, as if it can be done by using a phone app. Hope people read this article.
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Abdul Salam Kalhoro
Apr 07, 2020 07:58am
In pakistan only New experience may be observed on every new patient or deceased or virus,plasma thropy is really dangerios for the covid19 ptient so please follow the WHO procedure of treatment now time to treatment not New experiment on covid19 patient.
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Farooq Rathore
Apr 07, 2020 08:33am
@Dr. Salaria, Aamir Ahmad, Can you please share the link to the complete news ?
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Faisal Khan
Apr 07, 2020 09:06am
Thanks dawn for sharing such valuable information. The explanation in the article is simple and too the point.
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Anika Khan
Apr 07, 2020 11:31am
An informative article that provides useful and balanced information. Someone commented that the article was taking away 'the ray of hope' (from the Pakistani public) that plasma therapy potentially gives. I think that is incorrect. The article suggests that plasma therapy may help patients with COVID-19, but tempers hope with a sensible overview of the present status of research, and also presents associated risks.
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Timothy Kipkosgei
Apr 07, 2020 06:09pm
Great Article. It is indeed necessary that any new unproven intervention is administered with due ethical consideration to avoid harm. Everyone COVID-19 patient is vulnerable and must be protected by the regulatory authorities.
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well wisher
Apr 07, 2020 08:42pm
Well documented by the 3 authors. Keep media away until something worthwhile is ready. Great work!
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Sadaf Aba Umer Kodwavwala
Apr 08, 2020 01:33am
Thanks to The Dawn and authors for such an informative article. An article with well balanced information about different aspects of "Plasma Therapy", written in a way for understanding of common people. I agree that Media has to play a key role in providing relevant but complete information to the public rather than creating the false hype and scientific research should be done with all the professional and ethical standards.
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Sarmad Hussain Arijo
Apr 08, 2020 01:34am
Quite informative, specially Plasma Therapy and it's Consequences. Thank You for educating.
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