Convalescent Plasma / Hackensack Meridian Health - LARVOL DELTA

Genetic and Immunological Profiling of Recent SARS-CoV-2 Omicron Subvariants: Insights into Immune Evasion and Infectivity in Monoinfections and Coinfections. (PubMed, Viruses) - "Commercial antibodies and human convalescent plasma (HCoP) samples from unvaccinated donors were ineffective in neutralizing the most recent Omicron subvariants, particularly after the emergence of JN.1 subvariant...Our study demonstrated that pro-inflammatory cytokines IL-6, IFN-β, and IL-10 were upregulated in hBAEC following SARS-CoV-2 monoinfection with recent Omicron subvariants as well as during coinfection with IFAV_H1N1 and RSV. Taken together, our findings offer new insights into the immune evasion strategies and pathogenic potential of evolving SARS-CoV-2 Omicron subvariants, as well as their interactions with other respiratory viruses, carrying important implications for therapeutic development and public health preparedness."

Journal • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections • IFNB1 • IL10 • IL6

Convalescent Plasma as Treatment for Hospitalized Subjects With COVID-19 Infection (clinicaltrials.gov) - P2a | N=52 | Terminated | Sponsor: Hackensack Meridian Health | Active, not recruiting ➔ Terminated; Lack of eligible patients due to change in standard therapy

Trial termination • Infectious Disease • Novel Coronavirus Disease

Convalescent Plasma as Treatment for Subjects With Early COVID-19 Infection (clinicaltrials.gov) - P2 | N=21 | Terminated | Sponsor: Hackensack Meridian Health | Active, not recruiting ➔ Terminated; Lack of accrual

Trial termination • Infectious Disease • Novel Coronavirus Disease

Convalescent Plasma as Treatment for Subjects With Early COVID-19 Infection (clinicaltrials.gov) - P2 | N=21 | Active, not recruiting | Sponsor: Hackensack Meridian Health | Recruiting ➔ Active, not recruiting | N=306 ➔ 21

Enrollment change • Enrollment closed • Infectious Disease • Novel Coronavirus Disease

Convalescent Plasma as Treatment for Hospitalized Subjects With COVID-19 Infection (clinicaltrials.gov) - P2a | N=52 | Active, not recruiting | Sponsor: Hackensack Meridian Health | Trial completion date: Apr 2022 ➔ May 2023 | Trial primary completion date: Apr 2022 ➔ May 2023

Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

Convalescent Plasma as Treatment for Subjects With Early COVID-19 Infection (clinicaltrials.gov) - P2 | N=306 | Recruiting | Sponsor: Hackensack Meridian Health | Trial completion date: Nov 2021 ➔ Nov 2023 | Trial primary completion date: Nov 2021 ➔ Nov 2022

Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

Elevated cytokines and chemokines in peripheral blood of patients with SARS-CoV-2 pneumonia treated with high-titer convalescent plasma. (PubMed, PLoS Pathog) - "Furthermore, elevations in MIP-1α, MIP-1β and CRP correlated with disease progression of Track 2 recipients. Overall, our observations serve as a foundation for further study of these correlates and the identification of potential biomarkers to improve upon convalescent plasma therapy and to drive more successful patient outcomes."

Clinical • Journal • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases

Emergence of Multiple SARS-CoV-2 Antibody Escape Variants in an Immunocompromised Host Undergoing Convalescent Plasma Treatment. (PubMed, mSphere) - "In this study, we report the emergence of five different NTD and RBD mutations in an uncommon SARS-CoV-2 B.1.369 lineage from an immunosuppressed patient undergoing steroid and convalescent plasma therapy. The observation highlighted that VOCs can independently arise in immunocompromised populations undergoing anti-SARS-CoV-2 therapy, and enhanced measures will be required to reduce the transmission."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Transfusion-related acute lung injury in a COVID-19-positive convalescent plasma recipient: a case report. (PubMed, J Int Med Res) - "Despite treatment with tocilizumab, remdesivir, and intravenous steroids, worsening dyspnea prompted adjunctive treatment with convalescent plasma. Two hours after completion of the plasma transfusion, the patient developed hypoxia-induced cardiac arrest secondary to transfusion-related acute lung injury. This case sheds light on life-threatening transfusion reactions and emphasizes the need to investigate post-transfusion monitoring protocols as well as the possible role of surveillance equipment."

Clinical • Journal • Acute Lung Injury • Cardiovascular • Infectious Disease • Novel Coronavirus Disease • Pulmonary Disease • Respiratory Diseases

Convalescent Plasma as Treatment for Hospitalized Subjects With COVID-19 Infection (clinicaltrials.gov) - P2a; N=52; Active, not recruiting; Sponsor: Hackensack Meridian Health; Trial completion date: Apr 2021 ➔ Apr 2022; Trial primary completion date: Apr 2021 ➔ Apr 2022

Clinical • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

Convalescent Plasma as Treatment for Hospitalized Subjects With COVID-19 Infection (clinicaltrials.gov) - P2a; N=52; Active, not recruiting; Sponsor: Hackensack Meridian Health; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Infectious Disease • Novel Coronavirus Disease

Convalescent Plasma as Treatment for Subjects With Early COVID-19 Infection (clinicaltrials.gov) - P2; N=306; Recruiting; Sponsor: Hackensack Meridian Health; Not yet recruiting ➔ Recruiting; Trial completion date: Jul 2021 ➔ Nov 2021; Trial primary completion date: Jul 2021 ➔ Nov 2021

Clinical • Enrollment open • Trial completion date • Trial primary completion date • Alzheimer's Disease • Infectious Disease • Novel Coronavirus Disease

Convalescent Plasma as Treatment for Subjects With Early COVID-19 Infection (clinicaltrials.gov) - P2; N=306; Not yet recruiting; Sponsor: Hackensack Meridian Health; Initiation date: Jul 2020 ➔ Oct 2020

Clinical • Trial initiation date • Alzheimer's Disease • Infectious Disease • Novel Coronavirus Disease

Expanded Access to Convalescent Plasma for Treatment of COVID-19 (clinicaltrials.gov) - P; N=N/A; Temporarily Not Available; Sponsor: Hackensack Meridian Health

Clinical • New trial • Infectious Disease • Novel Coronavirus Disease

Convalescent Plasma as Treatment for Subjects With Early COVID-19 Infection (clinicaltrials.gov) - P2; N=306; Not yet recruiting; Sponsor: Hackensack Meridian Health

Clinical • New P2 trial • Alzheimer's Disease • Infectious Disease • Novel Coronavirus Disease

Convalescent Plasma as Treatment for Hospitalized Subjects With COVID-19 Infection (clinicaltrials.gov) - P2a; N=55; Not yet recruiting; Sponsor: Hackensack Meridian Health

Clinical • New P2a trial

Convalescent Plasma as Treatment for Hospitalized Subjects With COVID-19 Infection (clinicaltrials.gov) - P2a; N=55; Recruiting; Sponsor: Hackensack Meridian Health; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open