Convalescent plasma therapy / Erasmus MC - LARVOL DELTA

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

Early, very high-titre convalescent plasma therapy in clinically vulnerable individuals with mild COVID-19: an international, randomised, open-label trial. (PubMed, EBioMedicine) - P3 | "Early administration of high-titre CCP can prevent hospitalisation or death in immunocompromised patients with mild COVID-19."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

COVIC-19: Early High-Titre Convalescent Plasma in Clinically Vulnerable Individuals With Mild COVID-19 (clinicaltrials.gov) - P3 | N=120 | Terminated | Sponsor: Deutsches Rotes Kreuz DRK-Blutspendedienst Baden-Wurttemberg-Hessen | N=680 ➔ 120 | Recruiting ➔ Terminated; Due to the significant decline in the number of newly diagnosed infections and the difficulties in opening new centers in the outgoing pandemic, recruitment declined. The Data Safety Monitoring Board recommended to stop the trial.

Enrollment change • Trial termination • Infectious Disease • Neutropenia • Novel Coronavirus Disease • BCL2

Dosing of Convalescent Plasma and Hyperimmune Anti-SARS-CoV-2 Immunoglobulins: A Phase I/II Dose-Finding Study. (PubMed, Clin Pharmacokinet) - "The results of this study may inform future intervention studies on the prophylactic and therapeutic use of antiviral antibodies in the form of ConvP or COVIg."

Journal • P1/2 data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Convalescent plasma for patients with multiple myeloma and COVID-19; the European Myeloma Network consensus. (PubMed, Leukemia) - No abstract available

Journal • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Novel Coronavirus Disease • Oncology

High-titer convalescent plasma plus nirmatrelvir/ritonavir treatment for non-resolving COVID-19 in six immunocompromised patients. (PubMed, J Antimicrob Chemother) - "In immunocompromised patients with non-resolving COVID-19, the combination of nirmatrelvir/ritonavir and CP may be an effective treatment. Larger prospective studies are needed to confirm these preliminary results and should compare different treatment durations."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Management of patients with multiple myeloma and COVID-19 in the post pandemic era: a consensus paper from the European Myeloma Network (EMN). (PubMed, Leukemia) - "Pre-exposure prophylaxis with tixagevimab/cilgavimab is not effective against the new dominant variants and thus is no longer recommended. Oral antivirals (nirmatrelvir/ritonavir and molnupiravir) and remdesivir are effective against Omicron subvariants BA.2.12.1, BA.4, BA.5, BQ.1.1 and/or XBB.1.5 and should be administered in MM patients at the time of a positive COVID-19 test or within 5 days post symptoms onset. Convalescent plasma seems to have low value in the post-pandemic era. Prevention measures during SARS-CoV-2 outbreaks, including mask wearing and avoiding crowded places, seem prudent to continue for MM patients."

Journal • Review • Hematological Malignancies • Infectious Disease • Multiple Myeloma • Novel Coronavirus Disease • Oncology • Respiratory Diseases

Early, very high-titre convalescent plasma therapy in clinically vulnerable individuals with mild COVID-19 (COVIC-19): protocol for a randomised, open-label trial. (PubMed, BMJ Open) - P3 | "The findings will be published in peer-reviewed journals and presented at relevant stakeholder conferences and meetings. Clinical Trials.gov (NCT05271929), EudraCT (2021-006621-22)."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

COVID-19 Convalescent Plasma Outpatient Therapy to Prevent Outpatient Hospitalization: A Meta-analysis of Individual Participant Data From Five Randomized Trials. (PubMed, Clin Infect Dis) - "Among outpatients with COVID-19, treatment with COVID-19 convalescent plasma reduced the rate of all-cause hospitalization and may be most effective when given within 5 days of symptom onset and when antibody titer is higher."

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

Outpatient convalescent plasma therapy for high-risk patients with early COVID-19. A randomized placebo-controlled trial. (PubMed, Clin Microbiol Infect) - P3 | "In patients with early COVID-19, CP did not improve the 5-point disease severity score."

Journal • Infectious Disease • Novel Coronavirus Disease

Prospective individual patient data meta-analysis of two randomized trials on convalescent plasma for COVID-19 outpatients. (PubMed, Nat Commun) - P2, P3 | "NCT04621123 and NCT04589949 on https://www. gov."

Journal • Retrospective data • Infectious Disease • Novel Coronavirus Disease

Convalescent Plasma as Therapy for Covid-19 Severe SARS-CoV-2 Disease (CONCOVID Study) (clinicaltrials.gov) - P2/3 | N=86 | Terminated | Sponsor: Erasmus Medical Center | N=426 ➔ 86 | Active, not recruiting ➔ Terminated; new insights into COVID19 pathogenesis

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

Early Convalescent Plasma Therapy for High-risk Patients With COVID-19 in Primary Care (the CoV-Early Study) (clinicaltrials.gov) - P3 | N=420 | Terminated | Sponsor: Erasmus Medical Center | N=690 ➔ 420 | Trial completion date: Nov 2023 ➔ Mar 2022 | Recruiting ➔ Terminated | Trial primary completion date: Nov 2022 ➔ Oct 2021; vaccination uptake 80% in the target population/new COVID variant

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Infectious Disease • Novel Coronavirus Disease

Evidence based dosing of convalescent plasma for COVID-19 in future trials. (PubMed, Clin Microbiol Infect) - "In future trials on ConvP for COVID-19, more stringent donor selection criteria and/or higher volume transfusions should be used."

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

Interferon-α2 Auto-antibodies in Convalescent Plasma Therapy for COVID-19. (PubMed, J Clin Immunol) - "IFN-α2 Abs were detected by ELISA and neutralization assay in COVID-19 patients, but not in ICU patients with other respiratory illnesses. The presence of neutralizing IFN-α2 Abs in critically ill COVID-19 is associated with delayed viral clearance. IFN-α2 Abs in COVID-19 convalescent plasma donors were not neutralizing in the conditions tested."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNA1

Effects of treatment of COVID-19 with convalescent plasma in 25 B-cell depleted patients. (PubMed, Clin Infect Dis) - "All were treated with convalescent plasma with high neutralizing antibody titers. 21 (84%) recovered, indicating the potential therapeutic effects of this therapy in this particular population."

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

Effects of potent neutralizing antibodies from convalescent plasma in patients hospitalized for severe SARS-CoV-2 infection. (PubMed, Nat Commun) - "This resulted in the decision to terminate the trial prematurely. Treatment with convalescent plasma should be studied early in the disease course or at least preceding autologous humoral response development."

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

SARS-CoV-2 neutralizing human antibodies protect against lower respiratory tract disease in a hamster model. (PubMed, J Infect Dis) - "These data highlight the importance of screening plasma donors for high levels of neutralizing antibodies. Our data show that prophylactic administration of high levels of neutralizing antibody, either monoclonal or from convalescent plasma, prevent severe SARS-CoV-2 pneumonia in a hamster model, and could be used as an alternative or complementary to other antiviral treatments for COVID-19."

Journal • Preclinical • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

The ConvP COVig PKPD study: an investigation for the use of plasma or antibodies against the novel coronavirus (SARS-CoV-2) De ConvP COVig PKPD studie: een onderzoek naar nuttig gebruik van plasma of antilichamen voor behandeling van het nieuwe coronavirus (SARS-CoV-2) (clinicaltrialsregister.eu) - P1/2; N=104; Ongoing; Sponsor: Erasmus MC

New P1/2 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Convalescent Plasma as Therapy for Covid-19 Severe SARS-CoV-2 Disease (CONCOVID Study) (clinicaltrials.gov) - P2/3; N=426; Active, not recruiting; Sponsor: Erasmus Medical Center; Recruiting ➔ Active, not recruiting; Trial completion date: Jul 2020 ➔ Jul 2021; Trial primary completion date: Jul 2020 ➔ Jul 2021

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

Early Convalescent Plasma Therapy for High-risk Patients With COVID-19 in Primary Care (the CoV-Early Study) (clinicaltrials.gov) - P3; N=690; Recruiting; Sponsor: Erasmus Medical Center

Clinical • New P3 trial • Infectious Disease • Novel Coronavirus Disease

Convalescent Plasma as Therapy for Covid-19 Severe SARS-CoV-2 Disease (CONCOVID Study) (clinicaltrials.gov) - P2/3; N=426; Recruiting; Sponsor: Erasmus Medical Center

Clinical • New P2/3 trial