Use of face mask by blood donors during the COVID-19 pandemic: Impact on donor hemoglobin concentration: A bane or a boon.

BACKGROUND: COVID-19 virus has caused the world's deadliest pandemic. Early April 2020, the Delhi Government made it compulsory for people to wear face masks while going outdoors to curb disease spread. Prolonged use of surgical masks during the pandemic has been reported to cause many adverse effects. Intermittent hypoxia has been shown to activate erythropoietin (EPO leading to increased hemoglobin mass. AIM: To analyze whether face mask induced intermittent hypoxia has any effect on the hemoglobin levels of healthy blood donors. MATERIALS AND METHODS: We retrospectively analyzed donor data from 1st July 2019-31st December 2020 for hemoglobin distribution across hemoglobin ranges and donor deferral on basis of hemoglobin. Study population was divided into two cohorts Group 1- (1st July 2019-31 st March 2020): before implementation of mandatory face masks Group 2- (1st April 2020-31 st December 2020): after implementation of mandatory face masks RESULTS: Mean Hb of blood donors in Group 2 (15.01 ± 1.1 g/dl) was higher than Group1 (14.49 ± 1.15 g/dl), (p < 0.0001). 47.1 % group2 donors had Hb of 16.1-18 g/dl compared to group1 (38.4 %). 52.9 % group 2 donors had Hb between 12.5-15 g/dl compared to 61.6 % Group 1 (p < 0.05). Deferral due to anemia was lesser in group 2 compared to group 1 (p < 0.00001). Group 2 had significantly higher deferral due to high Hb (>18 gm/dl) was than Group 1 (p = 0.0039). CONCLUSION: This study including 19504 blood donors spanning over one and a half year shows that prolonged use of face mask by blood donors may lead to intermittent hypoxia and consequent increase in hemoglobin mass.

Position paper on the preparation of immune plasma to be used in the treatment of patients with COVID-19.

Passive immunotherapy with plasma derived from patients convalescent from SARS-CoV-2 infection can be a promising approach in the treatment of COVID-19 patients. It is important that Blood Establishments are prepared to satisfy requests for immune plasma by defining the requirements applicable to plasma donors and the standards for preparation, qualification, storage, distribution and control of use of the product. This position paper is aimed to give recommendations on biological characteristics of a plasma preparation from convalescent donors and to support the evaluation of this therapeutic approach in more rigorous investigations.

COVID-19 vaccination: The impact on the selection criteria of the convalescent plasma donors.

Clinical management protocols for COVID-19 are evolving rapidly as more information about the epidemiology and pathophysiological changes in COVID-19 become available. However, no definite treatment of COVID-19 has been found till date. The COVID-19 convalescent plasma (CCP) therapy has emerged as an important investigational therapy in the management of COVID-19 patients. Additionally, the regulatory agencies, in particular, the Indian blood transfusion council must release some interim recommendations for the blood centres on the CCP blood donor eligibility criteria after COVID-19 vaccination. More clinical trials are needed to know the efficacy of the CCP harvested from COVID-19 recovered individuals who have been vaccinated against those COVID-19 recovered individuals who are not vaccinated to understand the vaccine impact on the IgG titres of anti-SARS-CoV-2 antibodies.

COVID-19 vaccination in the Indian blood donors: Adjudging the impact on the deferral period.

The only efficacious way to provide people with herd immunity against the novel corona virus [nCoV] is to administer an appropriate vaccine and help check the current pandemic. With the genetic sequence data of the nCoV already available since January 10, 2020, leading pharmaceutical companies, world over, in turn, have started working on the clinical trials to produce vaccines against this nCoV. In fact, many vaccines under the Phase III trial have claimed to demonstrate their efficacy to be as high as 95% against the nCoV. In January, the central drugs standard control organization, India had granted the emergency-use authorization [EUA] to two vaccines namely, Covishield (live vaccine, Oxford-AstraZeneca, United Kingdom being manufactured by the Serum Institute of India, Pune) and Covaxin (inactivated vaccine, Bharat Biotech, India). Although, most of the countries offer no deferral period for the donors who have been administered an inactivated vaccine against this nCoV. However, the national blood transfusion council of India has recently recommended a donor deferral period of 28 days from the last dose of vaccination. This could essentially lead to a massive loss of eligible blood donors and jeopardize the already disrupted blood supply management due to the COVID-19 outbreak. The authors, herein, propose a thorough redefining of this deferral period post-vaccination amongst the Indian blood donors.

Bioethical perspective of convalescent plasma therapy for COVID-19: A systematic review.

Convalescent plasma therapy (CP) has long been used to prevent and treat various infectious diseases before COVID-19 such as SARS, MERS, and H1N1. Because the viral and clinical characteristics of COVID-19 share the similarities between SARS and MERS, CP treatment could be a promising treatment option to save COVID-19. With only low quality medical evidence, but massive media support and a very significant public demand for the use of convalescent plasma for COVID-19, we are now faced with an ethical dilemma. Therefore, this paper uses a structured analysis that focuses on the preferred reporting items for a systematic review of ethical issues regarding the use of Convalescent Plasma Therapy for COVID-19. The use of convalescent plasma must meet the ethical principles of autonomy; such as voluntary, informed consent, and confidentiality. Consideration of the risk-benefit ratio for potential donor recipients also needs to be considered in order to meet the beneficence and non-maleficence principles. The principle of justice also needs to be applied both to donors, donor recipients and health workers, such as determining the priority of donor recipients, due to the increasing demand for convalescent plasma amid the limited circumstances of patients who have recovered from Covid-19 who voluntarily donate.

Changes in Hematopoietic Cell Transplantation Practices in Response to COVID-19: A Survey from the Worldwide Network for Blood & Marrow Transplantation.

SARS-CoV-2 has spread rapidly worldwide, but the full impact of the COVID-19 pandemic on the field of hematopoietic cell transplantation (HCT) remains unknown. To understand this better, an 18-item online survey was disseminated by the Worldwide Network for Blood & Marrow Transplantation with questions exploring SARS-CoV-2 testing algorithms, mobilization, and cryopreservation strategies and COVID-19 infections in allogeneic related and autologous hematopoietic progenitor cell (HPC) donors. The aim of this survey was to assess the impact of the outbreak on policies relating to HPC mobilization, collection, and processing with respect to changes in daily routine. A total of 91 individual responses from distinct centers in 6 continents were available for analysis. In these centers, the majority (72%) of allogeneic related and autologous donors are routinely tested for SARS-CoV-2 before HPC collection, and 80% of centers implement cryopreservation of allogeneic HPC grafts before commencing conditioning regimens in patients. Five related and 14 autologous donors who tested positive for COVID-19 did not experience any unexpected adverse events or reactions during growth factor administration (eg, hyperinflammatory syndrome). These data are limited by the small number of survey respondents but nonetheless suggest that centers are following the recommendations of appropriate scientific organizations and provide some preliminary data to suggest areas of further study.

A Recipient and Donor Both Have COVID-19 Disease. Should We Perform a Liver Transplant?

Coronavirus 2019 (COVID-19) is a new infectious disease that continues to spread globally. There is growing concern about donor-induced transmission of Coronavirus 2 (SARS -CoV-2). For liver transplantation, the COVID-19 PCR test is routine, in addition to epidemiological history and clinical and radiological examination 24-48 h before surgery. One of the liver transplant candidates was found to be infected with COVID-19, as well as the planned donor candidate. Since COVID-19 will be a high-risk operation for both the recipient and the donor, the operation was postponed by giving medical treatment. After the treatment and quarantine process was over, the patient and the donor then had a negative COVID-19 PCR test and the patient received a living donor liver transplant. We present a case of donor and recipient who initially both tested positive for COVID-19. This liver transplantation scenario has not previously been reported in the literature.

The impact of COVID-19 pandemic on blood supplies and transfusion services in Eastern Mediterranean Region.

BACKGROUND: Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) has spurred a global health crisis. The safety and supply of blood during this pandemic has been a concern of blood banks and transfusion services as it is expected to adversely affect blood system activities. We aim to assess the situation in the Eastern Mediterranean Region (EMR) during the first months of the pandemic. MATERIALS AND METHODS: A survey was designed to address blood supply, transfusion demand, and donor management during the coronavirus disease-19 (COVID-19) pandemic. Medical directors of different blood banks were invited to participate. RESULTS: A total of 16 centers participated with representation from 15/19 countries in the region. In total, 75% were from national blood banks. Most centres had a decrease in the blood supply, ranging from 26-50%. Representatives from 14 countries (93.3%) believed that public fear has contributed to a decrease in donations. Most centres (n=12, 75%) had a reduction in transfusion demand, while those who did not, reported heavy involvement in treating patients with underlying haemoglobinopathies and haematological malignancies. Half of the centres activated their contingency plans. Four centres had to alter the blood donor eligibility criteria to meet demands. All centres implemented donor deferral criteria in relation to SARS-CoV-2, but were variable in measures to mitigate the risk of donor and staff exposure. CONCLUSION: Blood services in the region faced variable degrees of blood shortages. We summarize lessons learnt during this pandemic for the blood banks to consider to plan, assess, and respond proportionately to future similar pandemics.

Post-donation information and haemovigilance reporting for COVID-19 in Greece: Information supporting the absence of SARS-CoV-2 possible transmission through blood components.

BACKGROUND: Although the SARS-CoV-2 virus is transmitted mainly through the respiratory tract, possible transmission by transfusion from asymptomatic carriers should be explored. As yet there are no reports of transfusion transmission of COVID-19. Haemovigilance findings within a three-month surveillance period during the new coronavirus pandemic are presented. MATERIALS AND METHODS: Due to great demand and shortage, blood sessions in outpatient facilities were organized during the high prevalence period of COVID-19, alongside a national plan to monitor the evolving public health situation by random molecular screening of high-risk groups of the population. Haemovigilance protocols were implemented as well as surveillance for any COVID-19 case reported post-transfusion. A 14-day quarantine and follow-up molecular and antibody testing of any COVID-19 positive case was obligatory. RESULTS: Post-donation, post-transfusion information and molecular testing of swab samples collected from three asymptomatic donors at risk for COVID-19, revealed the case of an immunosupressed patient who had been transfused with whole blood derived platelets from a donor subsequently diagnosed with COVID-19. The recipient exhibited no symptoms of the disease. Molecular and antibody testing results were negative. CONCLUSION: Haemovigilance provided information supporting the absence of transfusion transmission of COVID-19, thus strengthening the hypothesis that, even if it cannot yet be definitively ruled out, COVID-19 is not transmitted through blood transfusion. As of early June 2020, a perfect test does not exist, therefore haemovigilance along with the implementation of strict proactive measures is crucial to identify eluding asymptomatic individuals and ensure blood safety during the pandemic.

Indian blood donor selection guidelines: Review in the context of the ongoing COVID-19 pandemic.

The National Blood Transfusion Services under the aegis of the ministry of health and family welfare, India has recently issued guidelines regarding the blood donor selection criteria and the processing of blood. Care has been taken to make the blood transfusions safer. However, COVID-19 has disrupted the organization of the voluntary blood donation drives, whole blood donations [WBD] and restricted the donors' movement to the blood transfusion centres all across the world. While sickness and the need for transfusions are very much in place, the gap of demand against blood collection has widened. Additionally, with the monsoon season at hand, and the categorical challenges of a dengue outbreak, the subsequent need for blood components especially the platelet concentrates is going to rise. Some of the criteria laid for deferring a blood donor from his or her WBD need a categorical revision, considering these unprecedented times. We, therefore, critically analyzed the blood donor selection criteria and hereby, suggest an updating regarding the pre-donation haemoglobin, sexually transmitted diseases, lactation, pregnancy and many such subheadings. We also suggest collecting smaller blood volumes in the blood bags for the optimal benefit of the recipients both for now and also as a measure of pandemic preparedness for future use.

Blood Donation and COVID-19: Reconsidering the 3-Month Deferral Policy for Gay, Bisexual, Transgender, and Other Men Who Have Sex With Men.

In April 2020, in light of COVID-19-related blood shortages, the US Food and Drug Administration (FDA) reduced the deferral period for men who have sex with men (MSM) from its previous duration of 1 year to 3 months.Although originally born out of necessity, the decades-old restrictions on MSM donors have been mitigated by significant advancements in HIV screening, treatment, and public education. The severity of the ongoing COVID-19 pandemic-and the urgent need for safe blood products to respond to such crises-demands an immediate reconsideration of the 3-month deferral policy for MSM.We review historical HIV testing and transmission evidence, discuss the ethical ramifications of the current deferral period, and examine the issue of noncompliance with donor deferral rules. We also propose an eligibility screening format that involves an individual risk-based screening protocol and, unlike current FDA guidelines, does not effectively exclude donors on the basis of gender identity or sexual orientation. Our policy proposal would allow historically marginalized community members to participate with dignity in the blood donation process without compromising blood donation and transfusion safety outcomes.

Feasibility of a pilot program for COVID-19 convalescent plasma collection in Wuhan, China.

BACKGROUND: A novel coronavirus has caused an international outbreak. Currently, there are no specific therapeutic agents for coronavirus infections. Convalescent plasma (CP) therapy is a potentially effective treatment option. METHODS: Patients who had recovered from COVID-19 and had been discharged from the hospital for more than 2 weeks were recruited. COVID-19 convalescent plasma (CCP)-specific donor screening and selection were performed based on the following criteria: 1) aged 18-55 years; 2) eligible for blood donation; 3) diagnosed with COVID-19; 4) had two consecutive negative COVID-19 nasopharyngeal swab tests based on PCR (at least 24 hr apart) prior to hospital discharge; 5) had been discharged from the hospital for more than 2 weeks; and 6) had no COVID-19 symptoms prior to convalescent plasma donation. In addition, preference was given to CCP donors who had a fever lasting more than 3 days or a body temperature exceeding 38.5°C (101.3°F), and who donated 4 weeks after the onset of symptoms. CCP collection was performed using routine plasma collection procedures via plasmapheresis. In addition to routine donor testing, the CCP donors' plasma was also tested for SARS-CoV-2 nucleic acid and S-RBD-specific IgG antibody. RESULTS: Of the 81 potential CCP donors, 64 (79%) plasma products were collected. There were 18 female donors and 46 male donors. There were 34 first-time blood donors and 30 repeat donors. The average time between CCP collection and initial symptom onset was 49.1 days, and the average time between CCP collection and hospital discharge was 38.7 days. The average volume of CCP collected was 327.7 mL. All Alanine transaminase (ALT) testing results met blood donation requirements. HIV Ag/Ab, anti-HCV, anti-syphilis, and HBsAg were all negative; NAT for HIV, HBV, and HCV were also negative. In addition, all of the CCP donors' plasma units were negative for SARS-CoV-2 RNA. Of the total 64 CCP donors tested, only one had an S-RBD-specific IgG titer of 1:160, all others had a titer of ≥1:320. CONCLUSION: Based on a feasibility study of a pilot CCP program in Wuhan, China, we demonstrated the success and feasibility of CCP collection. In addition, all of the CCP units collected had a titer of ≥1:160 for S-RBD-specific IgG antibody, which met the CCP quality control requirements based on the Chinese national guidelines for CCP.

Convalescent Plasma Therapy for COVID-19: State of the Art.

Convalescent plasma (CP) therapy has been used since the early 1900s to treat emerging infectious diseases; its efficacy was later associated with the evidence that polyclonal neutralizing antibodies can reduce the duration of viremia. Recent large outbreaks of viral diseases for which effective antivirals or vaccines are still lacking has renewed the interest in CP as a life-saving treatment. The ongoing COVID-19 pandemic has led to the scaling up of CP therapy to unprecedented levels. Compared with historical usage, pathogen reduction technologies have now added an extra layer of safety to the use of CP, and new manufacturing approaches are being explored. This review summarizes historical settings of application, with a focus on betacoronaviruses, and surveys current approaches for donor selection and CP collection, pooling technologies, pathogen inactivation systems, and banking of CP. We additionally list the ongoing registered clinical trials for CP throughout the world and discuss the trial results published thus far.

Convalescent plasma therapy in patients with COVID-19.

There are currently no licensed vaccines or therapeutics for COVID-19. Anti-SARS CoV-2 antibody-containing plasmas, obtained from the recovered individuals who had confirmed COVID-19, have been started to be collected using apheresis devices and stored in blood banks in some countries in order to administer to the patients with COVID-19 for reducing the need of intensive care and the mortality rates. Therefore, in this review, we aim to point out some important issues related to convalescent plasma (CP) and its use in COVID-19. CP may be an adjunctive treatment option to the anti-viral therapy. The protective effect of CP may continue for weeks and months. After the assessment of the donor, 200-600 mL plasma can be collected with apheresis devices. The donation interval may vary between countries. Even though limited published studies are not prospective or randomized, until the development of vaccines or therapeutics, CP seems to be a safe and probably effective treatment for critically ill patients with COVID-19. It could also be used for prophylactic purposes but the safety and effectiveness of this approach should be tested in randomized prospective clinical trials.