The ConvP COVig PKPD study: an investigation for the use of plasma or antibodies against the novel coronavirus (SARS-CoV-2)

Phase 1

• Conditions: COVID-19 or protective effect against in B-cell depleted patients or vaccination non-responders; MedDRA version: 23.1Level: LLTClassification code 10084464Term: COVID-19 immunizationSystem Organ Class: 100000004865; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2021-000864-32-NL
• Lead Sponsor: Erasmus MC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-19
• Last Update Posted: 5 July 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

18 years or older
Written informed consent
? B-cell depleted status because one of following:
o Prior B-cell depletion therapy (latest administration < 6 months prior to inclusion)
o Immunodeficiency requiring IVIG suppletion
? Wantai total Ig antibody optical density (OD) ratio of 2.0 or lower 2 weeks after complete vaccination against COVID-19
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

Exclusion Criteria

Symptoms of respiratory infection at time of inclusion
Anti-SARS-CoV-2 antibodies prior to administration of study product > 2.0 OD (Wantai total Ig)
Positive SARS-CoV-2 PCR
Known previous history of transfusion-related acute lung injury
Known IgA deficiency
Known hypersensitivity to human immunoglobulins
Liver cirrhosis
Received anti-SARS-CoV-2 vaccination in the 2 weeks preceding screening or between screening and baseline

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified