COVID-19 convalescent sera / Johns Hopkins University, University of Pittsburgh, Cedars-Sinai - LARVOL DELTA

CSSC-004: Convalescent Plasma to Limit SARS-CoV-2 Associated Complications (clinicaltrials.gov) - P2 | N=1225 | Completed | Sponsor: Johns Hopkins University | Active, not recruiting ➔ Completed | Trial completion date: Sep 2022 ➔ Dec 2022

Trial completion • Trial completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

CSSC-004: Convalescent Plasma to Limit SARS-CoV-2 Associated Complications (clinicaltrials.gov) - P2 | N=1225 | Active, not recruiting | Sponsor: Johns Hopkins University | Trial completion date: Jan 2023 ➔ Sep 2022 | Trial primary completion date: Dec 2022 ➔ Jan 2022

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

The feasibility of multiple units of convalescent plasma in mechanically ventilated patients with COVID-19: A pilot study. (PubMed, Transfus Apher Sci) - No abstract available

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Convalescent Plasma to Stem Coronavirus (CSSC-001) (clinicaltrials.gov) - P2 | N=180 | Completed | Sponsor: Johns Hopkins University | Active, not recruiting ➔ Completed | N=500 ➔ 180 | Trial completion date: Jan 2023 ➔ Jun 2021 | Trial primary completion date: Dec 2022 ➔ Apr 2021

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Human Convalescent Plasma for High Risk Children Exposed or Infected With SARS-CoV-2 (COVID-19) (clinicaltrials.gov) - P1; N=14; Completed; Sponsor: Johns Hopkins University; Active, not recruiting ➔ Completed; N=30 ➔ 14; Trial completion date: Jul 2023 ➔ Dec 2021; Trial primary completion date: Jul 2022 ➔ Sep 2021

Clinical • Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Pharmacokinetics of high-titer anti-SARS-CoV-2 human convalescent plasma in high-risk children. (PubMed, JCI Insight) - P1 | "Convalescent plasma transfused to high-risk children appears to be safe with expected antibody kinetics, regardless of weight or age. However, current use of convalescent plasma in high-risk children achieves low neutralizing capacity."

Clinical • Journal • PK/PD data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Convalescent Plasma in ICU Patients With COVID-19-induced Respiratory Failure (clinicaltrials.gov) - P1; N=6; Terminated; Sponsor: Noah Merin; N=60 ➔ 6; Recruiting ➔ Terminated; The initiation of the expanded access program for convalescent plasma.

Clinical • Enrollment change • Trial termination • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

CSSC-004: Convalescent Plasma to Limit SARS-CoV-2 Associated Complications (clinicaltrials.gov) - P2; N=1344; Active, not recruiting; Sponsor: Johns Hopkins University; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • PCR

Human Convalescent Plasma for High Risk Children Exposed or Infected With SARS-CoV-2 (COVID-19) (clinicaltrials.gov) - P1; N=30; Active, not recruiting; Sponsor: Johns Hopkins University; Trial completion date: Jun 2022 ➔ Jul 2023; Trial primary completion date: Jun 2021 ➔ Jul 2022

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

Human Convalescent Plasma for High Risk Children Exposed or Infected With SARS-CoV-2 (COVID-19) (clinicaltrials.gov) - P1; N=30; Active, not recruiting; Sponsor: Johns Hopkins University; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

IL-33 expression in response to SARS-CoV-2 correlates with seropositivity in COVID-19 convalescent individuals. (PubMed, Nat Commun) - "Analysis of published scRNAseq data of bronchoalveolar lavage fluid (BALF) from patients with mild to severe COVID-19 reveals a population of IL-33-producing cells that increases with the disease. Together these findings show that IL-33 production is linked to SARS-CoV-2 infection and warrant further investigation of IL-33 in COVID-19 pathogenesis and immunity."

Clinical • Journal • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD4 • IL1B • IL6

Convalescent Plasma to Stem Coronavirus (CSSC-001) (clinicaltrials.gov) - P2; N=500; Active, not recruiting; Sponsor: Johns Hopkins University; Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Peripheral Plasma Cells Associated with Mortality Benefit in Severe COVID-19: A Marker of Disease Resolution. (PubMed, Am J Med) - "Patients with severe disease who have detectable plasma cells in the peripheral blood have improved mortality despite adjusting for known covariates associated with disease severity in COVID-19. Further investigation is warranted to understand the role of plasma cells in the immune response to COVID-19."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

COVID-19: The Weekly Summary (October 23-29) [Google translation] (Medscape) - "Limited data so far do not support the use of this strategy in COVID-19, a new review in the Cochrane Database of Systematic Reviews has concluded . However, three ongoing clinical trials could confirm the benefit of early administration of convalescent plasma with high antibody titer, said Dr. Evan Bloch..."

Media quote

[VIRTUAL] Broad and Prevalent SARS-CoV-2 CD8+ T Cell Response in Recovered COVID-19 Individuals Demonstrates Kinetics of Early Differentiation (IDWeek 2020) - "Overall, SARS-CoV-2 T cells showed specific states of differentiation (stem-cell memory and transitional memory), which differed from those of MART-1, influenza, CMV and EBV-specific T cells.UMAP visualization revealed a phenotypic profile of SARS-CoV-2-specific CD8 T cells in COVID-19 convalescent donors that is distinct from other viral specificities, such as influenza, CMV, EBV and Adenovirus. The kinetics modeling demonstrates a dynamic, evolving immune response characterized by a time-dependent decrease in overall inflammation, increase in neutralizing antibody titer, and progressive differentiation of a broad SARS-CoV-2 CD8 T cell response. It could be desirable to aim at recapitulating the hallmarks of this robust CD8 T cell response in the design of protective COVID-19 vaccines."

Clinical • Late-breaking abstract • Infectious Disease • Novel Coronavirus Disease • CD8

[VIRTUAL] COVID-19 Convalescent Plasma - State of the Research (AABB 2020) - "Describe current research findings. Describe future research initiatives."

Infectious Disease • Novel Coronavirus Disease

[VIRTUAL] Development of a Database of Registered Clinical Trials Using Convalescent Plasma for Treatment of COVID-19: Is Data Harmonization Possible? (AABB 2020) - "Abstract Background/Case Studies: COVID-19 convalescent plasma (CCP) is a promising therapeutic option, but efficacy remains unknown... Meaningful groupings of CCP clinical trials based on common parameters were developed in the above framework. Overlaps as well as sources of heterogeneity among trials were identified. This framework allows the generation of preliminary recommendations to facilitate data harmonization across trials that may face accrual problems."

Clinical • Harmonization • Late-breaking abstract • Infectious Disease • Novel Coronavirus Disease

[VIRTUAL] Rapid Implementation of a COVID-19 Convalescent Plasma Program (AABB 2020) - "Rapid implementation and scale up of a CCP donation program was realized. We are currently able to meet the needs of hospitals in our regions including support of various clinical trials, as well as contribute to the national distribution of CCP. As focus changes, CCP can employed to the production of hyperimmune globulin."

Infectious Disease • Novel Coronavirus Disease

Convalescent Plasma as Treatment of COVID-19: What We Know So Far - August 12, 2020, 4:05 PM - 5:05 PM.

Live event

Convalescent Plasma to Stem Coronavirus (CSSC-001) (clinicaltrials.gov) - P2; N=487; Recruiting; Sponsor: Johns Hopkins University; N=150 ➔ 487

Clinical • Enrollment change • Infectious Disease • Novel Coronavirus Disease

Convalescent Plasma to Stem Coronavirus (CSSC-001) (clinicaltrials.gov) - P2; N=150; Recruiting; Sponsor: Johns Hopkins University; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Infectious Disease • Novel Coronavirus Disease

Human Convalescent Plasma for High Risk Children Exposed or Infected With SARS-CoV-2 (COVID-19) (clinicaltrials.gov) - P1; N=30; Recruiting; Sponsor: Johns Hopkins University; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Infectious Disease • Novel Coronavirus Disease

Convalescent Plasma in ICU Patients With COVID-19-induced Respiratory Failure (clinicaltrials.gov) - P1; N=60; Recruiting; Sponsor: Noah Merin; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Cardiovascular • Infectious Disease • Novel Coronavirus Disease • Reperfusion Injury • Respiratory Diseases

Human Convalescent Plasma for High Risk Children Exposed or Infected With SARS-CoV-2 (COVID-19) (clinicaltrials.gov) - P1; N=30; Not yet recruiting; Sponsor: Johns Hopkins University

Clinical • New P1 trial

Convalescent Plasma in ICU Patients With COVID-19-induced Respiratory Failure (clinicaltrials.gov) - P1; N=90; Not yet recruiting; Sponsor: Noah Merin

Clinical • New P1 trial • Cardiovascular • Infectious Disease • Novel Coronavirus Disease • Reperfusion Injury • Respiratory Diseases