Recommendations for Investigational COVID\19 Convalescent Plasma [Internet]. titers, dose, and at what stage of disease to transfuse. ABBREVIATIONSCCPCOVID\19 convalescent plasmaeINDemergency investigational new drugEAPExpanded Access ProgramNYBCNew York Blood Verteporfin CenterNYBCeNew York Blood Center EnterprisesSARS\CoV\2severe acute respiratory syndrome coronavirus\2 The coronavirus disease 2019 (COVID\19), which is caused by severe acute respiratory syndrome coronavirus\2 (SARS\CoV\2), pandemic, has resulted in 1.2 million cases and more than 70,000 deaths in the United States alone. 1 New York City is the center of the U.S. epidemic: more than 325,000 cases and 25,000 deaths have occurred in New York State, more than half (56%) of which have been reported in New York City as of May 5, 2020. 2 New York Blood Center Enterprises (NYBCe), which includes New York Blood Center (NYBC) and its operating divisions Community Blood Center of Kansas City, Missouri, Innovative Blood Resources, Blood Bank of Delmarva, and Rhode Island Blood Center, is headquartered and is the primarily blood supplier of New York City. We developed a COVID\19 convalescent plasma (CCP) program in partnership with our hospitals given plausible benefit to prevent and treat COVID\19. COVID\19 convalescent plasma is postulated to be effective through process of passive immunization, specifically transfer of neutralizing antibodies from a recovered individual to someone at risk of COVID\19 after exposure to SARS\COV\2 or treatment if already manifesting symptoms. Interest in CCP emerged early in the pandemic, given the prior application of CCP to treat other coronavirus diseases (i.e., SARS and Middle Eastern Respiratory Syndrome); 3 early examples of use of CCP during the COVID\19 epidemic in China demonstrated that CCP was safe and potentially beneficial in treatment of severe COVID\19. 4 , 5 , 6 Furthermore, CCP represents a virus\specific approach that can be implemented rapidly, while other disease specific therapies are still being developed. Being at the center of the COVID\19 pandemic, NYBCe and our partners took a leading role in the provision and transfusion of CCP. Our blood centers had the facilities and capabilities necessary to collect, test, and distribute CCP. Our goal is that every patient receives CCP upon hospital arrival. Here we describe our evolving work with CCP to meet that goal (Fig. ?(Fig.11). Open in a separate window Fig. 1 Phase implementation of CCP collection. Figure shows the differences between Phase I Verteporfin and Phase II processes. PHASE I: HOSPITAL PARTNERS RECRUIT DONORS New York Blood Center Enterprises initiated a CCP program with engagement of our hospitals in early March 2020. The hospitals assumed a major role in recruitment, given their ability to identify and test SARS\CoV\2Cpositive individuals. The program was conceived and designed before the launch of the FDA’s guidelines for use of CCP under a single\patient emergency investigational new drug (eIND) pathway to access CCP on March 24, 2020. 7 The eIND provided criteria for donor eligibility that included a prior diagnosis of COVID\19 as documented by laboratory test, complete resolution of symptoms for at least 14?days, a negative COVID\19 test result by nasopharyngeal swab or blood by molecular diagnostic Verteporfin Verteporfin test, and defined SARS\CoV\2Cspecific neutralizing antibody titers ( 1:320), if able to perform testing 7 (Table ?(Table1).1). The criteria also specified the MAPK3 compassionate use of CCP in COVID\19 patients with severe or immediately life\threatening disease. TABLE 1 Summary of FDA recommendations for CCP donor eligibility thead valign=”bottom” th align=”left” valign=”bottom” rowspan=”1″ colspan=”1″ Updates in FDA recommendations by date /th Verteporfin th align=”center” valign=”bottom” rowspan=”1″ colspan=”1″ March 24, 2020 /th th align=”center” valign=”bottom” rowspan=”1″ colspan=”1″ April 13, 2020 /th th align=”center” valign=”bottom” rowspan=”1″ colspan=”1″ May 1, 2020 /th /thead COVID\19 diagnosisPrior diagnosis of COVID\19 documented by a laboratory test. Evidence of COVID\19 documented by a laboratory test either by: 1. A diagnostic test (e.g., nasopharyngeal swab) at the time of illness OR 2. A positive serologic test for SARS\CoV\2 antibodies after recovery, if prior diagnostic screening was not performed at the time COVID\19 was suspected. Evidence of COVID\19 documented by a laboratory test either by: 1. A diagnostic test (e.g., nasopharyngeal swab) at the time of illness OR 2. A positive serologic test for SARS\CoV\2 antibodies after recovery, if prior diagnostic screening was not performed at the time COVID\19 was suspected. Time from last symptomsComplete resolution of symptoms at least 14?days before donation. Either one of the following: 1. Total resolution of symptoms at least 28?days before donation OR 2. Total resolution of symptoms at least 14?days before donation, AND negative results for COVID\19 either from one or more nasopharyngeal swab specimens or by a molecular diagnostic test from.
Recommendations for Investigational COVID\19 Convalescent Plasma [Internet]
