key: cord-0684272-pomtz2mz authors: Li, Ling; Yang, Ru; Wang, Jue; Lv, Qilu; Ren, Ming; Zhao, Lei; Chen, Hanwei; Xu, Haixia; Xie, Songli; Xie, Jin; Lin, Hui; Li, Wenjuan; Fang, Peng; Gong, Li; Gao, Xinqiang; Wang, Lan; Wu, Yanyun; Liu, Zhong title: Feasibility of a Pilot Program for COVID‐19 Convalescent Plasma Collection in Wuhan, China date: 2020-06-03 journal: Transfusion DOI: 10.1111/trf.15921 sha: 80bcabd25a14a95449f0f83fa0dd1c71e8231727 doc_id: 684272 cord_uid: pomtz2mz 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 two weeks were recruited. COVID‐19 convalescent plasma (CCP)‐specific donor screening and selection were performed based 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 h 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 Celsius, and 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. This article is protected by copyright. All rights reserved. In December 2019, a new type of human coronavirus, Severe Acute Respiratory Syndrome Type 2 Coronavirus (SARS-CoV-2), was discovered. The infection caused by the virus, named COVID-19 (coronavirus disease 2019), has been spreading rapidly worldwide. The World Health Organization has declared the outbreak of COVID-19 to be a pandemic. According to the WHO data, as of April 1, 2020, COVID-19 had resulted in a total of 823,626 confirmed cases and had killed 40,598 people globally [1] . Most patients with COVID-19 infection experience a series of clinical manifestations such as fever, cough, myalgia or fatigue, dyspnea, and even acute respiratory distress syndrome (ARDS) and secondary infections. Many critically ill patients have been admitted to intensive care units. [2, 3] . Existing reports have shown that the mortality rate ranges from 1%-4% [4] . The severity and epidemic potential of COVID-19 has paralyzed the world's health care system, claimed many lives, and threatened economic stability. Unfortunately, to date, apart from symptomatic treatment and supportive care, no specific antiviral treatment or vaccine has been proven effective [5] . Convalescent plasma (CP) containing SARS-CoV-2-specific antibodies from recovered patients is now been entertained as a potential treatment option [6] . CP has been used to treat several other viral infections, including severe acute respiratory syndrome coronavirus (SARS-CoV) [7] , Ebola virus [8] , Middle East espiratory syndrome coronavirus (MERS-CoV) [9] and avian influenza A(H5N1) virus [10] . A recent report by Shen et al. showed that the infusion of COVID-19 convalescent plasma (CCP) had resulted in significant clinical improvement in five critically ill patients with COVID-19 and ARDS [11] . CCP has been included as a treatment option in the Chinese COVID-19 treatment guidelines and a viral titer of 1:160 has been recommended as a product quality control indicator [12] . Recently, the US Food and Drug Administration created pathways for using CCP either under an emergency IND or expanded access [13] . For the past few months, CCP has been collected and used in China empirically. The descriptive data were reported. The minimal, maximal, median, average and SD were calculated by Excel. From 81 potential donors for CCP, 64 (79%) plasma products were collected; 17 of the potential donors could not donate plasma because they did not meet he blood donation requirements (2 had hypertension and 15 had abnormal ALT). There were 18 female donors and 46 male donors. Of the 64 donors, 34 were first-time blood donors and 30 were repeat donors. The average time between CCP collection and symptom onset were 49.1 days, and the average time between CCP collection and hospital discharge were 38.7 days. The average volume of CCP collected was 327.7 ml. All ALT testing met the blood donation criteria. The anti-HIV1/2, anti-HCV, syphilis testing, and HBsAg were all negative; the NAT for HIV, HBV, HCV were also negative. In addition, all CCP donors' plasma tested negative for SARS-CoV-2 RNA. Among the total 64 analyzed CCP donors, only one had an S-RBD-specific IgG titer of 1:160, all others had a titer ≥1:320. The COVID-19 pandemic has become a major public health challenge, not only for China but also for countries around the world. The development of an effective and safe CCP program may provide an effective treatment approach to help control the pandemic situation. Here we report a summary of a pilot CCP collection program. The program was able to attract recovered patients and successfully collected CCP products. The high rate of program exclusion is not surprising, because this was not a typical blood donation, and some patients may not have been fully recovered from COVID-19 or were not qualified as blood donors at baseline despite a high level of enthusiasm. It is also very encouraging to note that more that half of the CCP donors are committed repeat blood donors who were willing to come back after being very ill. From a blood safety perspective for CCP, it is also notable that we did not observe any positivity for routine TTD testing, or NAT for SARS-CoV-2 nucleic acid. This is rather assuring. From product quality control perspective, it is notable that all CCP donors in this pilot program had an S-RBD-specific IgG titer of ≥1:160, which met the Chinese national CCP standard. While the data are very limited, we did demonstrate the success and feasibility of a pilot CCP program. In addition, clinical validation based on well-designed clinical trials such as RCT will be needed for the safety and therapeutic efficacy of CCP. Clinical correlation with the donor selection criteria and product quality control indicators will help further refine the CCP program requirements. Based on a feasibility study of a pilot CCP program in Wuhan China, we demonstrated the success and feasibility of CCP collection. All donors who donated CCP during the study period had negative routine TTD, including negative NAT for HIV, HBV, and HCV, and negative NAT for SARS-CoV-2. In addition, all donors had a titer ≥ 1:160 for S-RBD-specific IgG antibody, which met the CCP quality control requirements based on the Chinese national guidelines for CCP. This article is protected by copyright. All rights reserved. Accepted Article This article is protected by copyright. All rights reserved. Accepted Article World-Health-Organization Coronavirus disease (COVID-19) outbreak Available online at Clinical features of patients infected with 2019 novel coronavirus in Wuhan The COVID-19 epidemic StatPearls [Internet Convalescent plasma as a potential therapy for We would like to thank the following individuals for their guidance, expertise, This article is protected by copyright. All rights reserved.