|Year : 2020 | Volume
| Issue : 2 | Page : 169-172
Challenges in the collection of convalescent plasma for COVID-19 patients at a plasma therapy trial site
Nidhi Bhatnagar, Mamta Shah, Tarak Patel, Dolly Gohel, Hinal Prajapati, Rajvi Vora
Department of IHBT, B J Medical College and Civil Hospital, Ahmedabad, Gujarat, India
|Date of Submission||18-Jun-2020|
|Date of Decision||21-Sep-2020|
|Date of Acceptance||30-Sep-2020|
|Date of Web Publication||13-Nov-2020|
Department of IHBT, B J Medical College and Civil Hospital, Ahmedabad, Gujarat
Source of Support: None, Conflict of Interest: None
Background and Objectives: With no proven treatment guidelines for COVID-19, human convalescent plasma is an option and has been under trial worldwide. In India, Indian Council for Medical Research (ICMR), started a Mulicentric Trial for the use of convalescent plasma in the treatment of COVID patients. The purpose of this paper is to analyse the challenges encountered in the collection of convalescent plasma from COVID recovered patients at a trial site. Methods: The current prospective study was carried out in a tertiary care hospital based blood centre catering to COVID patients and a trial site for Plasma therapy by ICMR. For analysing the challenges in the collection of convalescent plasma, the discharged patients were contacted telephonically. After applying eligibility criteria, the reasons of deferral were assessed. Data was collected and analysed. Results: The current prospective study was carried out during the period of 1st April 2020 to 15th May 2020. During this period, a total of 496 patients got discharged. After applying deferral criteria, 113 were eligible, out of which only 13 (11.5%) consented to come to donate plasma. Conclusion: In a global ongoing pandemic, the “Fear Factor” is a constraint and a major challenge to motivate and convince a COVID recovered patient for plasma donation. The challenge for the medical professionals is to motivate, convince and educate the potential donors and society about the likely benefits of COVID Convalescent Plasma.
Keywords: Challenges, convalescent plasma collection, trial
|How to cite this article:|
Bhatnagar N, Shah M, Patel T, Gohel D, Prajapati H, Vora R. Challenges in the collection of convalescent plasma for COVID-19 patients at a plasma therapy trial site. Glob J Transfus Med 2020;5:169-72
|How to cite this URL:|
Bhatnagar N, Shah M, Patel T, Gohel D, Prajapati H, Vora R. Challenges in the collection of convalescent plasma for COVID-19 patients at a plasma therapy trial site. Glob J Transfus Med [serial online] 2020 [cited 2021 Apr 13];5:169-72. Available from: https://www.gjtmonline.com/text.asp?2020/5/2/169/300629
| Introduction|| |
The novel coronavirus disease (COVID-19), which began in Wuhan, China, in December 2019, has been declared to be a pandemic by the World Health Organization. Caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), COVID-19 has resulted in 4,307,287 cases and 295,101 deaths globally (till May 15, 2020), affecting 216 countries. In India, there are 51,401confirmed cases, 27,919 recoveries, and 2649 deaths from COVID-19 (to May 15, 2020). Beyond supportive care, there are currently no proven therapeutic options for pneumonia due to COVID-19, the infection caused by SARS-CoV-2. Human convalescent plasma is an option for the treatment of COVID-19 as these persons would have high titer neutralizing immunoglobulin-containing plasma.
Since COVID-19 convalescent plasma (CCP) was approved by the USFDA as an experimental treatment for patients with COVID-19, facilities have been collecting CCP throughout the US. In India, permission to conduct a Clinical Trial of Convalescent Plasma for COVID-19 patients was given by the Drug Controller General of India in early April 2020. Thereafter, the Indian Council for Medical Research (ICMR), started enrolling sites across the country by inviting applications from institutions catering to COVID patients, to join a multicentric trial. During the course of enrolling, many discussions were carried out by patient experts to look into the criteria for donor selection for plasma donations. The trial was officially rolled out on May 4, 2020.
Aims and objectives
The purpose of this article is to analyze the challenges encountered in the collection of convalescent plasma from COVID recovered patients.
| Materials and Methods|| |
The current prospective study was carried out in a tertiary care hospital-based blood center catering to COVID patients, which was one of the multicentric trial sites for plasma therapy by ICMR. For analyzing the challenges in the collection of convalescent plasma, the daily discharge list of patients from the dedicated 1200 bedded COVID hospital was taken from the period of April 1, 2020 to May 15, 2020. After looking into their age, symptoms, date of discharge, and eligibility criteria, [Table 1], they were contacted telephonically. The rationale behind plasma collection, procedure in detail, time taken, tests to be carried out and risks of the procedure, etc., were explained to each provisional donor. Data were collected and analyzed.
|Table 1: Criteria for donor selection for convalescent plasma collection|
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The numbers being small the data were analyzed manually.
The study was cleared by the Institutional ethic committee. Consent of all patients/donors participating was taken according to SOPs and protocol of the ICMR PLACID trial.
| Results|| |
The current prospective study was carried out during the period of April 1, 2020–May 15, 2020. During this period, a total of 495 patients got discharged. The total number of patients was divided into two categories as shown in [Figure 1] and [Figure 2]. Category I discharged from hospital from April 1, 2020 to April 30, 2020 and Category II discharged from hospital from May 1, 2020 to May 15, 2020. Category I patients could be enrolled as donors as they had completed the 14 days, whereas, for Category II patients, telephonically consent was obtained. Each category was further divided on the basis of age and sex criteria for eligibility.
|Figure 1: Category I: Discharged from the hospital from April 1, 2020 to April 30, 2020|
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|Figure 2: Category II: Discharged from the hospital from May 1, 2020 to May 15, 2020|
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As shown in [Table 2], after age and multipara criteria, seventy-four, out of 150 recovered patients were eligible to donate. Out of these, only one donated plasma and the rest of the patients were deferred due to reasons mentioned.
|Table 2: Status of eligible donors with respect to donating plasma (April 01-30, 2020)|
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As shown in [Table 3], after age and multipara criteria, one hundred and fifty-five, out of three hundred, and forty-six recovered patients were eligible to donate. Out of these, only twelve donated plasma.
|Table 3: Status of eligible donors with respect to donating plasma (May 01-15, 2020)|
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In both the periods, after applying deferral criteria, 113 were eligible, out of which only 13 (11.5%) consented to come to donate plasma.
| Discussion|| |
As we await more research, the role of plasma therapy in the treatment of COVID-19 patients is still debatable. Plasma therapy trials conducted globally have given positive interim results. In the Mayo Clinic plasma therapy trial, the researchers report that the early timing of plasma transfusions in a cohort of 35,322 patients was associated with lower mortality.
In India, the results of the PLACID Trial indicate that there is no difference in the 28-day mortality or progression to severe COVID-1, across the trial arms. The authors feel that it might be a little easier to conduct the ongoing drug trials for COVID-19, as it involves only patient part, whereas in the case of the plasma therapy trial, the biggest hurdle across all trials centers, is the collection of convalescent plasma.
Blood centers are not unaware of the challenges of motivating a blood donor and maintaining blood stocks. This was more felt during the global COVID pandemic in the situation of lockdowns and social distancing. In a recent article by Choudhury et al., there were major challenges in low- and middle-income countries in terms of shortages in blood donors and supply, safety of staff, donors and public, logistics of test kits and consumables, communication, and transport and convalescent plasma. Hence, when it is a challenge to motivate healthy eligible prospective donors, how hard would it be to motivate a person who has just recovered from illness and that too a scary one?
The plasma trial protocol mentions that before discharge of a patient, he/she would be counseled to come back for plasma donation. However, with a heavy rush of patients, as in our center, where on an average there are around 1000 patients admitted in the dedicated COVID hospital, it may not be always possible. Furthermore, when we look at the list of discharged patients, a majority come under the exclusion criteria of donor selection. As of today, worldwide, there is no hard data on how many donors were eligible and volunteered, but according to Jed Gorlin, in Kansas City, as many as half of the convalescent plasma donors were not eligible.
From the remaining, very few consents to come forward and donate. One specific reason mentioned by some eligible donors was the fear of contracting the disease again if they visit a COVID facility, though they would be ready to donate in a standalone blood center. The ICMR Placid Trial report too mentions that recovered patients who had the moderate or severe disease were generally reluctant to return to hospitals for plasma donation. This has major implications for obvious operational reasons as CP therapy for COVID-19 gets scaled up as a component of COVID-19 management strategy not only in India but also globally.
In some of our prospective plasma donors, even when the donor was willing, the family was instrumental in denying consent. Hence, the emotional quotient also played a big role. Furthermore, the patient load being very high, there was no support from the treating clinicians in motivating the discharged patients.
The limitations of this study were that it was a short study undertaken as rapid response during the COVID 19 pandemic and there was hardly any time to plan and executive plasma donor motivation strategies.
It would be pertinent to say that the blood centres are only one part of the Trial Team, the other part being the clinical side. Here, not only the efforts of both teams but the hospital management also come into play. There can be dedicated counselors trained for the purpose. The media, both print, and digital also can play a positive role in this matter. Our center did some positive stories of plasma donations in both print and digital media. Posters and video clips for appeal were designed and circulated on Twitter and Facebook (both in the English and local language), though not much of response was received.
The American Association of Blood Banks (AABB) has created a dedicated website for this. This site is a resource to educate interested donors, the health care community, and the public on the rapidly evolving therapy of CCP. It is a beautiful collection of data and links which has answers to almost every query. It even has suggestions for hospitals on how to appeal to donors.
Regarding the plasma therapy trial, the hurdles and challenges could possibly be overcome by sharing of experiences as we move further in the course.
| Conclusion|| |
Blood donation is inherently an altruistic act and in normal times, donors are healthy individuals who volunteer to donate. In a global ongoing pandemic, the “Fear Factor” is a constraint in motivating potential blood donors for whole blood donations and an even major challenge to motivate and convince a COVID recovered patient for plasma donation. It has affected the physical as well as mental well-being of all concerned.
The challenge for the medical professionals is to motivate, convince, and educate the potential donors and society about the likely benefits of COVID convalescent plasma.
The authors acknowledge the ICMR for accepting their application and enrolling their institute as a trial site.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
Government of India. Ministry of Health and Family Welfare. Novel Corona Virus Updates. 2020. Available from: https://www.mohfw.gov.in/
. [Last accessed on 2020 May 15].
US Food and Drug Administration. Recommendations for Investigational COVID-19 Convalescent Plasma. FDA. 2020. Available from: https://www.covidplasma.org
. [Last accessed on 2020 Apr 10].
Choudhury N, Mathur A, Cees Th Smit Sibinga, On behalf of AATM. COVID-19 Pandemic – blood supply challenges and approaches in AATM member countries. ISBT Science Series published by John Wiley & Sons Ltd. on behalf of International Society of Blood Transfusion. ISBT Science Series 2020:1-9.
[Figure 1], [Figure 2]
[Table 1], [Table 2], [Table 3]