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Vol. 42. Issue S2.
Pages 520-521 (November 2020)
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Vol. 42. Issue S2.
Pages 520-521 (November 2020)
877
Open Access
CHALLENGES IN THE PRODUCTION OF COVID-19 CONVALESCENT PLASMA – ANALYSIS OF DONOR RECRUITMENT
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E.J. Sekiyaa, M. Bellessoa, L.M.C. Sarmentoa, M.N.C. Rodriguesa, P.G. Rochab, M.I. Moraes-Pintoc, A.C.C.V. Soaresc, J.E. Levic, L.A.D. Ribeirod, A. Alvesd
a Instituto de Ensino e Pesquisa IEP-São Lucas, São Paulo, SP, Brazil
b Hospital Santa Paula, São Paulo, SP, Brazil
c Dasa, São Paulo, SP, Brazil
d Hemocentro São Lucas, São Paulo, SP, Brazil
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Introduction: Currently, we are facing a global pandemic COVID-19 caused by SARS-CoV-2. Since the first reported Brazilian case on February 26th to July 31st, 2020, Brazil has presented as the second country of the world with the highest number of cases and deaths: 2,662,485 and 92,475, respectively. Moreover, São Paulo presented most Brazilian data with 542,304 cases with 22,997 deaths. From February 2020, in an attempt to provide passive immunization in Severe COVID-19 patients, several international trials have appeared that addressed the subject. On March 24th the Food and Drug Administration (FDA) was published the First recommendation for COVID-19 convalescent plasma (C19CP) donor eligibility. Based on these criteria, we designed a clinical trial that estimate 10 Severe COVID-19 patients. In these abstract we describe the challenges in the production of C19CP, that is the secondary objective of the trial. Objective: We analyze the success rate in the recruitment of potential C19CP donors. Methodology: This prospective clinical trial was approved by “Comitê Nacional de Ética em Pesquisa”on June 5th 2020. Recruitment was started immediately by social media, direct referral of patients after discharge for COVID-19 and our knowledge network. Donor Inclusion criteria were: age ≥ 18; weight > 50 kg; previous registered COVID-19 diagnosis; complete resolution of symptoms at least 14 days; male donors or female donors who have not been pregnant; negative results for COVID-19 both nasopharyngeal swab sample and investigational plasma product by Real Time polymerase chain reaction (RT-PCR); SARS-CoV-2 IgG antibody index > 3.4 (Euroimmun Anti-SARS-CoV-2 ELISA) and all of eligibility criteria by Brazilian laws. Exclusion criteria were unviable venous access for plasmapheresis (UVAP). Eligible donors were submitted to plasmapheresis. Every plasmapheresis was divided into two 250 mL units and 100 mL to analysis. Results: We started recruitment on June 22nd, 2020 forty-nine volunteers responded to the recruitment. Initially 18 (36.74%) were excluded by interview and venous access examination due to: 4 (8.16%) withdrawal; 4 (8.16%) pregnancy history; 2 (4.09%) co-morbidities: 1 diabetes mellitus and 1 asthma; 3 (6.12%) did not present documented previous COVID-19; 4 (8.16%) UVAP and 1 (2.05%) previous blood transfusion. During second screening steps 17 (34.69%) donor were excluded due to: 4 (8.16%) Positive COVID-19 nasopharyngeal swab specimens by RT-PCR; 5 (10.2%) SARS-CoV-2 IgG antibody not detected; 6 (12.25%) SARS-CoV-2 IgG antibody index < 3.4 and 2 (4.08%) UVAP. Thus, in a total of 49 volunteers we obtained 14 (28.57%) donors. Conclusion: The donation success rate for C19CP found was 28.57%.

Idiomas
Hematology, Transfusion and Cell Therapy

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