COVID-19
Conditions
Interventions
Infusion of convalescent plasma or Nanogam plus (IVIG-therapy containing anti-SARS-CoV-2 antibodies)
Sponsors
Erasmus MC
Eligibility
Inclusion criteria
Inclusion criteria: - 18 years or older - Informed consent - B-cell depleted status because one of following: * Prior B-cell depletion therapy (latest administration < 6 months prior to inclusion) * Common variable immunodeficiency requiring IVIG suppletion
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: ? Symptoms of respiratory infection at time of inclusion ? Anti-SARS-CoV2 antibodies prior to administration of study product ? 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 4 weeks preceding screening or baseline
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ? Pharmacokinetics of virus neutralizing antibodies of ConvP ? Pharmacokinetics of virus neutralizing antibodies of Nanogam®plus | — |
Secondary
| Measure | Time frame |
|---|---|
| ? The incidence of COVID-19 during follow-up until antibody levels have become undetectable ? Percentage of patients with adverse events after administration of convalescent plasma ? Percentage of patients with adverse events after administration of Nanogam®plus | — |
Contacts
Public ContactBart Rijnders
Erasmus MC
Outcome results
None listed