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). The primary outcome was time to disease progression through 28 days (i.e., to PaO2/FiO2 <100 mmHg) or all-cause mortality at 28 days. Convalescent plasma treatment of severe COVID-19: a propensity score-matched control study. The researchers also analyzed plasma titers in 17 other patients besides the 72-year-old woman, both before and after they were given convalescent plasma for treatment of COVID-19. Secondary objectives were to obtain data on the safety of the intervention. Twenty percent of the participants were African American, 35% were Hispanic/Latino, and 5% were Asian. FDA Authorizes Convalescent Plasma As Emergency Treatment For COVID-19 : Coronavirus Updates President Trump announced on Sunday that the FDA granted emergency use authorization to … 2020 Available at: Gharbharan A, Jordans CCE, GeurtsvanKessel C, et al. Additionally, the study was not blinded. Fifty-three of 66 participants had anti-SARS-CoV-2 antibodies at baseline despite being symptomatic for a median time of only 10 days. Compliance and Enforcement Policy Regarding Investigational New Drug Requirements for Use of Convalescent Plasma. Mair-Jenkins J, Saavedra-Campos M, Baillie JK, et al. The researchers also analyzed plasma titers in 17 other patients besides the 72-year-old woman, both before and after they were given convalescent plasma for treatment of COVID-19. As such, its administration must be under the EUA or an IND. The primary endpoint was in-hospital mortality up to 60 days after admission. The use of convalescent plasma isn’t new; it was used during the Spanish flu pandemic in an effort to save lives. 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. CBER requests that all forms be filled out electronically to facilitate rapid review. The overall mortality rate was 8.6% at 7 days. This difference did not reach statistical significance. Health care providers are encouraged to enroll patients in those trials and complete clinical trials to fully answer the questions about the effectiveness of convalescent plasma for the treatment of COVID-19. Among those with severe disease, 91% of the convalescent plasma recipients and 68% of the control patients improved by Day 28 (difference of 23%; OR 1.34; 95% CI, 0. COVID-19 is an emerging, rapidly evolving situation, Plasma from donors who have recovered from COVID-19 may contain antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that may help suppress the virus and modify the inflammatory response.1. Please refer to the FDA’s Recommendations for Investigational COVID-19 Convalescent Plasma website for guidance on the transfusion of investigational convalescent plasma while blood establishments develop the necessary operating procedures to manufacture COVID-19 convalescent plasma in accordance with the Conditions of Authorization set forth in the EUA. 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). Convalescent plasma therapy is a century-old technique used to supply antibodies to critically ill patients who have few, if any, treatment options left. During this period of enforcement discretion and beyond, FDA will continue to work with any investigators who wish to submit INDs for the study of investigational convalescent plasma. For requests when the provider is unable to complete and submit Form FDA 3926 due to extenuating circumstances, or in the case of a medical emergency during the hours of 8pm and 8am Eastern Time (ET), i.e., when authorization and issuance of an IND number is needed before 8 am ET the next morning, the provider should contact FDA’s Office of Emergency Operations at 1-866-300-4374 to be routed to the appropriate clinical review staff for assistance with submitting the request and issuance of an IND number. FDA intends to exercise this temporary enforcement discretion provided the following circumstances are present: In addition, we recommend the measurement of neutralizing antibody titers when available. The lack of an untreated control arm limits interpretation of the safety and efficacy data. Both the Food and Drug Administration (FDA) and the Mayo Clinic performed retrospective, indirect evaluations of efficacy by using the Mayo Clinic EAP data, hypothesizing that patients who received plasma units with higher titers of SARS-CoV-2 neutralizing antibodies would have better clinical outcomes than those who received plasma units with lower antibody titers. Secure .gov websites use HTTPS Clinical trials of COVID-19 convalescent plasma in children are ongoing. Another study compared convalescent plasma with standard of care in patients with COVID-19 who were hospitalized between March 28 and July 6, 2020, at eight Houston Methodist hospitals. 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. There was no significant difference in mortality (16% vs. 24% of patients in the treatment and control groups, respectively; P = 0.30). The study was terminated early, and thus lacked sufficient power to detect differences in clinical outcomes between the study groups. Convalescent plasma to treat COVID-19: Chinese strategy and experiences. 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. Ongoing clinical trials of investigational convalescent plasma should not be amended because of this enforcement discretion policy. After the assessment of the donor, 200-600 mL plasma can be collected with apheresis devices. The safety and effectiveness of COVID-19 convalescent plasma have not been evaluated in pediatric patients. At 24 hours, the rates of negative SARS-CoV-2 viral polymerase chain reaction were significantly higher in the convalescent plasma group (45%) than in the control group (15%; P = 0.003), and differences persisted at 72 hours. The study was not blinded, and, on average, convalescent plasma was administered approximately 1 month into the disease course. Effect of convalescent plasma therapy on time to clinical improvement in patients with severe and life-threatening COVID-19: a randomized clinical trial. The results of retrospective case-controlled studies that evaluated outcomes among COVID-19 convalescent plasma recipients have been published.11 In one such study of patients who were hospitalized between March 24 and April 8, 2020, at Mount Sinai Hospital in New York City, outcomes among 39 consecutive patients who received convalescent plasma with a SARS-CoV-2 anti-spike antibody titer of 1:320 were compared to outcomes among 156 propensity-score-matched controls. 2020. 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. Convalescent plasma has been widely used as a treatment for COVID-19 but to date there has been no convincing evidence of the effect of convalescent plasma on clinical outcomes in patients admitted to hospital with COVID-19. The guidance also provides recommendations to blood establishments on collection. Subgroup analyses suggested a benefit of convalescent plasma among patients who were not intubated, had a shorter duration of symptoms, and received therapeutic anticoagulation. 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 protective effect of CP may continue for weeks and months. The 83 nonfatal SAEs that were assessed as possibly or probably related to the convalescent plasma treatment included 37 TACO events, 20 TRALI events, and 26 severe allergic reactions. An IND application for expanded access is an alternative for use of investigational convalescent plasma for patients with serious or immediately life-threatening COVID-19 disease who are not eligible or who are unable to participate in randomized clinical trials (21 CFR 312.305). In each arm, 17 participants progressed to severe disease (7.2% in the convalescent plasma arm vs. 7.4% in the standard of care arm).5. Official websites use .gov On August 23, 2020, FDA issued an emergency use authorization (EUA) for COVID-19 convalescent plasma for the treatment of hospitalized patients with COVID-19. Health care providers or acute care facilities should obtain convalescent plasma from an FDA registered or licensed blood establishment. 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. The emergency use of COVID-19 convalescent plasma is not authorized under the EUA unless it is consistent with, and does not exceed, the terms of the Letter of Authorization, including the Scope of Authorization and Conditions of Authorization. As cases of COVID-19 surge, hospitals across the country are at a breaking point. Ongoing clinical trials of investigational convalescent plasma should not be amended based on the issuance of the EUA. Secondary objectives were to obtain data on the safety of the intervention. Treatment of coronavirus disease 2019 patients with convalescent plasma reveals a signal of significantly decreased mortality. 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. Hand written forms are often hard to read and may delay the processing of the request. EUA of COVID-19 convalescent plasma for the treatment of COVID-19 in hospitalized patients: fact sheet for health care providers. Also, the study was terminated early, and thus lacked sufficient power to detect differences in clinical outcomes between the study groups. 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