anti-SARS-CoV-2 convalescent plasma / Mayo Clinic - LARVOL DELTA

COVID-19 convalescent plasma safety and efficacy analysis for biologics license application approval. (PubMed, Expert Rev Anti Infect Ther) - "Ultimate regulatory approval required robust randomized control efficacy data. Future infectious disease outbreaks require randomized controlled trials in the convalescent plasma roadmap."

BLA • Journal • Review • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Cardiac troponin T elevation predicts mortality in hospitalized COVID-19 patients. (PubMed, Am Heart J Plus) - P=N/A | "We examined high-sensitivity cardiac troponin T (hs-cTnT) levels in 1050 severely ill hospitalized COVID-19 patients who had hs-cTnT data available and participated in the Expanded Access Program for convalescent plasma study during the first wave (April-August 2020) of the COVID-19 pandemic...This finding was present regardless of sex or age. These data indicate the prognostic ability of hs-cTnT to predict mortality in hospitalized COVID-19 patients across all relevant patient groups.Clinical Trials registration number: NCT04338360."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Convalescent plasma for COVID-19: planning for the next pandemic using the worldwide experience. (PubMed, Clin Microbiol Rev) - "When the next pandemic occurs, humanity is likely to resort to CP again. To avoid another chaotic rollout, planning for CP use should begin well before that emergency arrives and must involve both physician education on the principles of antibody therapy and clinical trial designs that test its efficacy in optimal conditions, which include early use with sufficient antibody doses."

Journal • Review • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

COVID-19 convalescent plasma for B-cell depleted patients: a systematic review and individual patient data meta-analysis. (PubMed, Front Med (Lausanne)) - "Overall survival in our cohort of B-cell depleted patients was consistent with prior meta-analysis of randomized controlled trials on survival of immunocompromised patient transfused with CCP (~84%). A novel finding from this analysis is that vaccine-boosted CCP is associated with a high survival benefit."

Journal • Retrospective data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

AM25-MN-40-L - COVID-19 Convalescent Plasma in the Immunocompromised Patient (AABB 2025) - "Describe the current and future use of convalescent plasma Describe FDA’s recommendations to blood establishments for the submission of a Biologics License Application for the manufacture of COVID-19 convalescent plasma for transfusion intended to treat inpatients and outpatients with immunosuppressive disease or receiving immunosuppressive treatment. Describe a blood center’s experience in submitting a Biologics License Application for CCP to the FDA"

Clinical • Infectious Disease • Novel Coronavirus Disease

The European Conference on Infections in Leukaemia (ECIL-10) guidelines for COVID-19 should take convalescent plasma into proper consideration. (PubMed, Leukemia) - No abstract available

Journal • Hematological Malignancies • Infectious Disease • Leukemia • Novel Coronavirus Disease • Oncology

The Safety Profile of COVID-19 Convalescent Plasma. (PubMed, Curr Top Microbiol Immunol) - "The well-known complications of blood and plasma transfusions-transfusion-associated circulatory overload and transfusion-related acute lung injury-were found with no higher incidence than with standard use of blood and plasma, nor was there evidence for antibody-dependent enhancement or increased incidence of thromboembolic events. The comprehensive safety profile derived from studies enrolling hundreds of thousands of recipients of COVID-19 convalescent plasma across the world should allay safety fears about the rapid deployment of convalescent plasma in future pandemics."

Journal • Acute Lung Injury • Cardiovascular • Infectious Disease • Metabolic Disorders • Novel Coronavirus Disease • Respiratory Diseases

Using Passive Antibody Therapies in the Next Pandemic. (PubMed, Curr Top Microbiol Immunol) - "However, convalescent plasma therapy can be available as soon as there are survivors and is likely to be effective if used early and in sufficient strength...We cannot afford to wait until the next pandemic is upon us to respond. The time to strengthen clinical, research, and manufacturing infrastructure to permit us to be ready to confront the next new virulent pathogen is now."

Journal • Infectious Disease

Creating a plasma coordination center to support COVID-19 outpatient trials across a national network of hospital blood banks. (PubMed, J Clin Transl Sci) - "A core investigational team adapted a cloud-based platform to randomize patient assignments and track inventory distribution of control plasma and high-titer COVID-19 convalescent plasma of different blood groups from 29 donor collection centers directly to blood banks serving 26 transfusion sites. Distributing more than 3,100 plasma units to blood banks charged with managing investigational inventory across the U.S. in a decentralized manner posed operational and regulatory challenges while providing opportunities for the plasma coordination center to contribute to research of global importance. This program can serve as a template in subsequent public health emergencies."

Journal • Infectious Disease • Novel Coronavirus Disease

Estimates of actual and potential lives saved in the United States from the use of COVID-19 convalescent plasma. (PubMed, Proc Natl Acad Sci U S A) - "CCP deployment was a successful strategy for ameliorating the impact of the COVID-19 pandemic in the USA. This experience has important implications for convalescent plasma use in future infectious disease emergencies."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Descriptions of Scientific Evidence and Uncertainty of Unproven COVID-19 Therapies in US News: Content Analysis Study. (PubMed, JMIR Infodemiology) - "These results highlight that while scientific evidence is discussed relatively frequently in news reports, scientific uncertainty is infrequently reported and rarely found in prominent headlines and lead paragraphs."

Journal • Infectious Disease • Novel Coronavirus Disease

The Importance of Geographic Proximity of Convalescent Plasma Donors. (PubMed, Curr Top Microbiol Immunol) - "Our recommendations include prioritizing virus genotyping for vulnerable patients, establishing a robust testing infrastructure, and collecting additional donor data to enhance plasma selection. This chapter underscores the importance of comprehensive data collection and sharing to navigate the evolving landscape of newly emerging infectious diseases."

Journal • Infectious Disease • Novel Coronavirus Disease

Convalescent plasma and predictors of mortality among hospitalized COVID-19 patients: a systematic review and meta-analysis. (PubMed, Clin Microbiol Infect) - "In-hospital transfusion of CCP within 7 days from symptom onset conferred a mortality benefit."

Clinical • Journal • Retrospective data • Review • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Convalescent Plasma and the US Expanded Access Program: A Personal Narrative. (PubMed, Curr Top Microbiol Immunol) - "Writing just 4 years after the initiation of the EAP, this intense professional effort, comprising many moving parts, remains hard to completely understand or fully explain in this brief narrative. As Nelson Mandela said of the perception of time during his decades in prison, "the days seemed like years, and the years seemed like days.""

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Passive immunotherapies for the next influenza pandemic. (PubMed, Rev Med Virol) - "We review here the phylogeny of former influenza pandemics, and discuss candidate lineages. After briefly reviewing the other existing antiviral options, we discuss in detail the evidences supporting the efficacy of passive immunotherapies against influenzavirus, with a focus on convalescent plasma."

Journal • Review • Infectious Disease • Influenza • Respiratory Diseases

Outpatient treatment with concomitant vaccine-boosted convalescent plasma for patients with immunosuppression and COVID-19. (PubMed, mBio) - "We found that the administration of vaccine-boosted convalescent plasma was associated with a significantly decreased incidence of hospitalization among immunocompromised COVID-19 outpatients. Our data add to the contemporary data providing evidence to support the clinical utility of high-titer convalescent plasma as antibody replacement therapy in immunocompromised patients."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety and Efficacy of Convalescent Plasma Combined with Other Pharmaceutical Agents for Treatment of COVID-19 in Hospitalized Patients: A Systematic Review and Meta-Analysis. (PubMed, Diseases) - "Plasma collected from people recovered from COVID-19 (COVID-19 convalescent plasma, CCP) was the first antibody-based therapy employed to fight the pandemic. The current evidence from the literature suggests a potential beneficial effect on mortality of combined CCP plus remdesivir compared to CCP alone in hospitalized COVID-19 patients. No significant clinical interaction was found between CCP and steroids."

Journal • Retrospective data • Review • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Infectious Diseases Society of America Guidelines on the Diagnosis of COVID-19: Serologic Testing. (PubMed, Clin Infect Dis) - "The high seroprevalence of antibodies against SARS-CoV-2 worldwide limits the utility of detecting anti-SARS CoV-2 antibody. The certainty of available evidence supporting the use of serology for diagnosis was graded as very low to low. Future studies should use serologic assays calibrated to a common reference standard."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Outpatient COVID-19 convalescent plasma recipient antibody thresholds correlated to reduced hospitalizations within a randomized trial. (PubMed, JCI Insight) - P2 | "High antibody level plasma units, given early, should be reserved for therapeutic use. Trial registration: NCT04373460 FUNDING Defense Health Agency and others."

Clinical • Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Convalescent plasma: An unexpected new therapeutic option for critically ill COVID-19 patients coming from the past. (PubMed, J Clin Anesth) - No abstract available

Journal • Infectious Disease • Novel Coronavirus Disease

Convalescent Plasma for Covid-19-Induced ARDS. (PubMed, N Engl J Med) - No abstract available

Journal • Infectious Disease • Novel Coronavirus Disease

Safety of COVID-19 convalescent plasma: A definitive systematic review and meta-analysis of randomized controlled trials. (PubMed, Transfusion) - No abstract available

Journal • Retrospective data • Review • Cardiovascular • Infectious Disease • Novel Coronavirus Disease

COVID-19 outcome is not affected by anti-CD20 or high-titer convalescent plasma in immunosuppressed patients. (PubMed, Sci Rep) - "COVID-19 directed therapy included anti-spike monoclonal antibodies (n = 30, 20.8%), and, among those hospitalized within 14 days (n = 50), remdesivir (n = 45, 90.0%), glucocorticoids (n = 36, 72.0%) and convalescent plasma (n = 24, 48.0%). Administration of convalescent plasma within 14 days of the COVID-19 diagnosis was not significantly associated with any study outcome. Further study of COVID-19 in CD20-depleted individuals is needed focusing on the early administration of new and potentially combination antiviral agents, associated or not with vaccine-boosted convalescent plasma."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

COVID-19 convalescent plasma therapy decreases inflammatory cytokines: a randomized controlled trial. (PubMed, Microbiol Spectr) - "This decrease in IL-6 levels after early CCP treatment suggests a possible role of inflammation in COVID-19 progression. The evidence of IL-6 involvement brings insight into the possible mechanisms involved in CCP treatment mitigating SARS-CoV-2 severity."

Journal • Infectious Disease • Inflammation • Novel Coronavirus Disease • Respiratory Diseases • IL6

Recommendations on the use of COVID-19 Convalescent Plasma to Treat Immunocompromised Patients. (PubMed, Semin Thromb Hemost) - No abstract available

Journal • Infectious Disease • Novel Coronavirus Disease