NL-OMON51004
Completed
Not Applicable
A Phase I-II study of virus neutralizing antibodies against SARS-CoV-2. A focus on convalescent plasma and hyperimmune anti-SARS-CoV2 immunoglobulines - ConvP/COVig PK/PD study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Erasmus MC, Universitair Medisch Centrum Rotterdam
- Enrollment
- 44
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial is onging in other countries
Investigators
Eligibility Criteria
Inclusion Criteria
- •\* 18 years or older
- •\* Informed consent
- •\* B\-cell depleted status because one of following:
- •o Prior B\-cell depletion therapy (latest administration \< 6 months prior to
- •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
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
- •\* Liver cirrhosis
- •\* Known hypersensitivity to human immunoglobulins
- •\* Received anti\-SARS\-CoV\-2 vaccination in the 2 weeks preceding screening or
Outcomes
Primary Outcomes
Not specified
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