When it comes to Convalescent plasma therapy, it has been around since the late 19th century. It is not a new treatment and has been used in the treatment of infectious diseases. It was first used to treat diphtheria in the 1890s and is credited as having saved over 45,000 lives annually in an era when antibiotics were not yet discovered. More recently, it was used to treat patients in the 2014 – 2016 Ebola outbreak in West Africa.
EARLY FINDINGS FROM USA:
Although promising, convalescent plasma has not yet been shown to be safe as a treatment for COVID-19. In a study published on medrxiv, the experience from the first 5000 patients with COVID-19 transfused with convalescent plasma provides no signal of toxicity beyond what is expected from plasma use in severely ill patients. According to this study that was published from the US, despite early and encouraging safety signals, there are several risks of COVID-19 convalescent plasma transfusion in critically-ill patients that warrant attention. The paper suggests that research should shift focus toward determining the efficacy of convalescent plasma.
Researchers advise is that the new results should be interpreted with caution because they have not yet been published in a peer-reviewed medical journal or thoroughly reviewed by independent scientists.
WORLD’S LARGEST CLINICAL TRIAL IN CANADA:
Canada is conducting the world’s largest clinical trial for the plasma-based treatment of COVID-19. The trial is estimated to be completed in three months and will involve more than 1,000 patients.
The trial involves approximately 50 institutions across Canada with the participation of researchers from the Université de Montreal, McMaster University and the University of Toronto among others. The project called CONCOR, is trying to figure out if plasma from previous COVID-19 patients could provide antibodies to help current patients fight the disease more effectively.
CONCOR-1: A Randomized, Open-Label Trial of CONvalescent Plasma for Hospitalized Adults With Acute COVID-19 Respiratory Illness
Canadian Blood Services (CBS) is leading the Canadian effort and has partnered with international researchers and experts in Australia, Germany, France, Italy, China, South Korea, the United Kingdom and the United States.
According to CBS, in addition to meeting Canada’s current plasma donor eligibility criteria, to participate, convalescent plasma donors must be:
- Previously confirmed positive for COVID-19 by a laboratory test
- Younger than 67 years old
- Fully recovered from the virus and symptom-free for at least 28 days.
GROUNDBREAKING BLOOD PLASMA TRIAL – UK
NHS Blood and Transplant has asked some people who recovered from Covid-19 to donate blood so they can potentially assess the therapy in trials. More than 6,500 people registered their interest in the plasma donation programme, which is being led by NHS Blood and Transplant on behalf of the government.
Plasma collection has begun through the convalescent plasma programme, and trial transfusions will follow. The transfusions are being done through the REMAP-CAP trial and the RECOVERY trial.
REMAP-CAP uses a novel and innovative adaptive trial design to evaluate a number of treatment options simultaneously and efficiently. This design is able to adapt in the event of pandemics and increases the likelihood that patients will receive the treatment that is most likely to be effective for them.
We are rapidly building our capability to collect plasma so that we can quickly move into supplying hospitals at scale, should the trial demonstrate patient benefit, Dr. Gail Miflin – Chief Medical Officer, NHS Blood and Transplant
COCHRANE ANALYSIS:
Cochrane provides high-quality, relevant, up-to-date systematic reviews and other synthesized research evidence to inform health decision making. Cochrane searched major medical databases for clinical studies on treatment with convalescent plasma or hyperimmune immunoglobulin for people with COVID-19. Studies could be conducted anywhere in the world and include participants of any age, gender or ethnicity, with mild, moderate or severe COVID-19.
Cochrane analysis provides the following conclusion:
We are very uncertain whether plasma from people who have recovered from COVID-19 is an effective treatment for people with COVID-19. The completed studies we found were poor quality and their results could be related to the natural progression of the disease, other treatments that the participants received, or to convalescent plasma. However, our searches found 48 ongoing studies: 47 evaluating convalescent plasma and 1 evaluating hyperimmune immunoglobulin, of which 22 are randomised.
SOUTH ASIAN AND UAE PERSPECTIVES:
In India: The Indian Council for Medical Research (ICMR) is currently studying its efficacy.
According to the Head of ICMR Aparna Mukherjee: There are no scientific evidence that it works. Only randomized controlled trials can ascertain whether a particular drug works in a particular disease or not. There are no randomized controlled trials on Convalescent Plasma. ICMR is doing a randomized controlled trial to find out whether it works in the Indian context or not.
When asked, how doctors should decide on administering plasma therapy? The head of ICMR responded by saying, “they should do it only as part of clinical trial.” she stated further in an interview with Huffington Post India.
In Pakistan, in mid-May, Pakistan’s National Institute of Blood Diseases (NIBD) confirmed that the first coronavirus patient who had been treated with plasma therapy had recovered.
The Pakistan Society of Hematology (PSH) has issued a policy statement on June 14, 2020 regarding the use of convalescent plasma in COVID-19. This comes in the wake of massive social media campaigns where people have been requesting for plasma donors and encouraging COVID-19 survivors to come forward.
In the policy statement, Dr. Parvez Ahmed, President of PSH, is requesting health department and regulatory bodies in Pakistan to steps to stop the illegal and potentially harmful plasma trade. The statement concludes by emphasizing the need to apprise healthcare professionals and the general public about the potential harm from unnecessary use of convalescent plasma.
In an update today on June 15, 2020, the Government of Pakistan has released a detailed document describing the protocols relating to convalescent plasma therapy (CP). The guidelines clearly state that CP is still an experimental therapy it can only be safely used under controlled settings as part of the research protocol. The guidelines document is posted here.
The Dubai Health Authority (DHA) announced in May, the launch of three clinics to collect convalescent plasma from recovered COVID-19 patients, revealing that one patient can donate three dosages, which can save 2-3 lives. Dr. Younis Kazim, CEO of the Dubai Healthcare Corporation at DHA stressed the importance of convalescent plasma therapy as it can speed the recovery of patients by 85 to 90%. He added that the authority established these clinics to collect the largest number of donations to treat coronavirus patients. He explained that once a person recovers from the virus they develop antibodies that will stay in their blood to fight the same virus. Dr. Kazim concluded by stating that the authority will also be introducing stem cell therapy to its treatment protocols in partnership with the Abu Dhabi Stem Cell Centre after receiving the needed approvals, completing the trial period successfully and the laws and precautionary guidelines needed are introduced.
In the meantime, COVID-19 is resulting in a massive surge in daily cases being reported. Brazil, USA, India, Russia and Pakistan are the top 5 countries reporting a rising number of cases.
Cover Photo: Andrii Vodolazhskyi/Shutterstock.com
