No differences in mortality (P = 0.95), length of hospital stay (P = 0.68), or disease severity at Day 15 (P = 0.58) were observed between the study arms.4. The analyses suggested a trend towards benefit of convalescent plasma, with larger differences in mortality seen primarily among subgroups of patients who were transfused early (i.e., within 72 hours of admission) with high-titer plasma (i.e., anti-spike protein receptor binding domain titer ≥1:1350).12, Other smaller, uncontrolled case series that describe clinical outcomes in patients with COVID-19 have been reported and also suggest that SAEs are uncommon following COVID-19 convalescent plasma treatment.1,13-18. Effect of convalescent plasma therapy on time to clinical improvement in patients with severe and life-threatening COVID-19: a randomized clinical trial. Exploratory objectives included assessment of 7-day and 28-day mortality. Multiple studies have now reported the use of COVID-19 convalescent plasma (CCP) to treat severely or critically ill COVID-19 patients, without unexpected or serious adverse events (see below). Antibody testing to assess titers of donated plasma was not available when the trial started. Excerpts from the guidance document are provided below. Effect of convalescent plasma therapy on viral shedding and survival in COVID-19 patients. The investigational convalescent plasma is intended for the treatment of hospitalized patients with COVID-19. The safety and effectiveness of COVID-19 convalescent plasma have not been evaluated in pediatric patients. After the assessment of the donor, 200-600 mL plasma can be collected with apheresis devices. The Fact Sheet also provides a description of the product, information on the dosage, administration and storage of COVID-19 convalescent plasma, use in specific populations, and instructions for communicating with recipients. This process allows the use of an investigational drug for the treatment of an individual patient by a licensed physician upon FDA authorization, if the applicable regulatory criteria are met. The Expanded Access to Convalescent Plasma for the Treatment of Patients with COVID-19 program was an open-label, nonrandomized EAP that was primarily designed to provide adult patients who have severe or life-threatening (critical) COVID-19 with access to convalescent plasma. FDA recommends that physicians seeking to use convalescent plasma for hospitalized COVID-19 patients should do so under the EUA and not under single patient INDs. The Center for Biologics Evaluation and Research (CBER) Office of Blood Research and Review (OBRR) is committed to engaging with sponsors and reviewing such requests expeditiously. Hypothermia, metabolic complications, and post-transfusion purpura have also been described.7. Secure .gov websites use HTTPS Looking for U.S. government information and services. The protective effect of CP may continue for weeks and months. ) or https:// means you’ve safely connected to the .gov website. Available at: Food and Drug Administration. For example, the possibility that differences in outcomes are attributable to harm from low-titer plasma rather than benefit from high-titer plasma cannot be excluded. Treatment with convalescent plasma for COVID-19 patients in Wuhan, China. Note:  Given that the intended use of COVID-19 convalescent plasma under the EUA is for treatment of hospitalized COVID-19 patients, FDA expects few requests for single patient INDs. Latest public health information from CDC, Statement on Casirivimab Plus Imdevimab EUA, Chloroquine or Hydroxychloroquine With or Without Azithromycin, Clinical Data: Chloroquine or Hydroxychloroquine, Lopinavir/Ritonavir and Other HIV Protease Inhibitors, Table 2 Characteristics of Antiviral Agents, Table 3a Immune-Based Therapy Clinical Data, Table 3b Characteristics of Immune-Based Therapy, FDA’s Recommendations for Investigational COVID-19 Convalescent Plasma website, Expanded Access to Convalescent Plasma for the Treatment of Patients with COVID-19, https://www.ncbi.nlm.nih.gov/pubmed/32497196, https://www.fda.gov/media/141477/download, https://www.fda.gov/media/141480/download, https://www.medrxiv.org/content/10.1101/2020.07.01.20139857v1, https://www.medrxiv.org/content/10.1101/2020.09.03.20187252v2, https://www.fda.gov/media/141481/download, https://www.fda.gov/media/141478/download, https://www.ncbi.nlm.nih.gov/pubmed/32492084, https://mayoclinicproceedings.org/pb/assets/raw/Health%20Advance/journals/jmcp/jmcp_ft95_6_8.pdf, https://www.ncbi.nlm.nih.gov/pubmed/32817978, https://www.ncbi.nlm.nih.gov/pubmed/32934372, https://www.ncbi.nlm.nih.gov/pubmed/32795424, https://www.ncbi.nlm.nih.gov/pubmed/32511574, https://www.ncbi.nlm.nih.gov/pubmed/32281317, https://www.medrxiv.org/content/10.1101/2020.04.07.20056440v1, https://www.ncbi.nlm.nih.gov/pubmed/32293713, https://academic.oup.com/jid/advance-article/doi/10.1093/infdis/jiaa228/5826985, https://www.ncbi.nlm.nih.gov/pubmed/32253318, https://www.ncbi.nlm.nih.gov/pubmed/12904626, https://www.ncbi.nlm.nih.gov/pubmed/15616839, https://www.ncbi.nlm.nih.gov/pubmed/25030060, https://www.ncbi.nlm.nih.gov/pubmed/92624. The RECOVERY trial has closed recruitment to its randomised study of convalescent plasma treatment for patients hospitalised with COVID-19. Fifty-three of 66 participants had anti-SARS-CoV-2 antibodies at baseline despite being symptomatic for a median time of only 10 days. The median time from symptom onset to study randomization was 27 days in the treatment group and 30 days in the control group.8. A. COVID-19 Convalescent plasma is the liquid part of blood collected from patients who have recovered from a COVID-19 infection. Because SARS and MERS are both coronaviruses, a few reports showing small amounts of success with convalescent plasma led researchers to try using the therapy in COVID-19 patients. Patients were transfused with 1 or 2 units (200–500 mL) of convalescent plasma. The Expanded Access to Convalescent Plasma for the Treatment of Patients with COVID-19 program was an open-label, nonrandomized EAP that was primarily designed to provide adult patients who have severe or life-threatening (critical) COVID-19 with access to convalescent plasma. LockA locked padlock Following issuance of the EUA for COVID-19 convalescent plasma on August 23, 2020, FDA has received numerous inquiries from blood establishments and health care providers regarding investigational convalescent plasma that was collected prior to the EUA and remains in inventory and the need to continue to collect investigational convalescent plasma while operational changes are being made to meet the requirements in the EUA. The results of their analyses suggest that convalescent plasma with high antibody titers may be more beneficial than low-titer plasma in nonintubated patients, particularly when administered within 72 hours of COVID-19 diagnosis. Liu STH, Lin HM, Baine I, et al. Food and Drug Administration. Due to the decreasing incidence of COVID-19 in Wuhan, the trial was terminated early after 103 of the planned 200 patients were enrolled. Available at: Food and Drug Administration. There is no widely available and generally agreed-upon best test for measuring neutralizing antibodies, and the antibody titers of plasma from patients who have recovered from COVID-19 are highly variable. In addition, the Agency is aware that the National Expanded Access Treatment Protocol has been discontinued as of August 28, 2020. These risks include transfusion-transmitted infections (e.g., human immunodeficiency virus [HIV], hepatitis B, hepatitis C), allergic reactions, anaphylactic reactions, febrile nonhemolytic reactions, transfusion-related acute lung injury (TRALI), transfusion-associated circulatory overload (TACO), and hemolytic reactions. 2020 Available at: Gharbharan A, Jordans CCE, GeurtsvanKessel C, et al. Randomized clinical trials that are evaluating convalescent plasma for the treatment of COVID-19 are underway; a list is available at ClinicalTrials.gov. Convalescent plasma therapy is a century-old technique used to supply antibodies to critically ill patients who have few, if any, treatment options left. The following pathways are available for administering or studying the use of COVID-19 convalescent plasma: Health care providers intending to administer COVID-19 convalescent plasma under the EUA are not required to report its use to FDA. An official website of the United States government. CBER requests that all forms be filled out electronically to facilitate rapid review. Now, as Elise Preston reports, one treatment that could help the sickest patients is in short supply, convalescent plasma. Available at: Li L, Zhang W, Hu Y, et al. EUA 26382: emergency use authorization (EUA) request. As described in the Fact Sheet, health care providers must maintain records and conduct a thorough investigation of adverse reactions after transfusion of COVID-19 convalescent plasma, and must report fatalities to FDA as required in 21 CFR 606.170. Use of convalescent plasma therapy in SARS patients in Hong Kong. Ongoing clinical trials of investigational convalescent plasma should not be amended based on the issuance of the EUA. Participants in the intervention arm received two doses of 200 mL plasma, transfused 24 hours apart. Mair-Jenkins J, Saavedra-Campos M, Baillie JK, et al. There was no significant difference between the treatment and control groups in time to clinical improvement within 28 days (HR 1.40; 95% CI, 0.79–2.49; P = 0.26). Plasma is the liquid portion of blood that contains proteins, including antibodies (Figure 1). There had been huge international interest in the role of convalescent plasma as a possible treatment for hospital patients with Covid-19. Before sharing sensitive information, make sure you're on a federal government site. Concept of Using Convalescent Plasma to Treat COVID-19 Convalescent plasma is a blood product believed to provide passive antibody therapy through the transmission of neutralizing viral antibodies. Outcomes for the first 136 convalescent plasma recipients who reached Day 28 post-transfusion were compared with the outcomes for two sets of propensity-score matched controls at 28 days after admission. An open-label, randomized clinical trial of convalescent plasma versus standard of care for hospitalized patients with COVID-19 was conducted in 39 tertiary care centers in India from April 22 to July 14, 2020. There are insufficient data for the COVID-19 Treatment Guidelines Panel (the Panel) to recommend either for or against the use of COVID-19 convalescent plasma for the treatment of COVID-19. The life-threatening events that were reported up to 7 days after transfusion included 87 thrombotic/thromboembolic complications, 406 sustained hypotension events, and 643 cardiac events. A peer-reviewed publication described the safety outcomes for the first 20,000 EAP plasma recipients, enrolled between April 3 and June 2, 2020.9 One-third of the participants were aged ≥70 years, 60% were men, and 71% had severe or life-threatening COVID-19. The use of convalescent plasma isn’t new; it was used during the Spanish flu pandemic in an effort to save lives. The convalescent plasma Expanded Access Program for the treatment of COVID-19 extends its gratitude to participating acute care facilities, blood collection centers and health care providers for providing access to a potential therapy for COVID-19. The guidance provides recommendations on the following: Because convalescent plasma for the treatment of COVID-19 has not yet been approved for use by FDA,  it is regulated as an investigational product. The treating health care provider obtains adequate informed consent from the patient or his or her legally authorized representative for the use of the investigational convalescent plasma. During the COVID-19 pandemic, INDs may be submitted via email to CBERDCC_eMailSub@fda.hhs.gov. Treatment of coronavirus disease 2019 patients with convalescent plasma reveals a signal of significantly decreased mortality. Convalescent plasma letter of authorization. To obtain a single patient emergency IND, the requesting physician may contact FDA by completing Form FDA 3926 (https://www.fda.gov/media/98616/download) and submitting the form by email to CBER_eIND_Covid-19@FDA.HHS.gov. The primary outcome was time to clinical improvement within 28 days. Investigators wishing to study the use of convalescent plasma in a clinical trial should submit requests to FDA for investigational use under the traditional IND regulatory pathway (21 CFR Part 312).

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