A Phase I-II study of virus neutralizing antibodies against SARS-CoV-2. A focus on convalescent plasma and hyperimmune anti-SARS-CoV2 immunoglobulines

Recruiting

• Conditions: COVID-19

• Registration Number: NL-OMON22629
• Lead Sponsor: Erasmus MC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 104

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
? Pharmacokinetics of virus neutralizing antibodies of ConvP<br>? Pharmacokinetics of virus neutralizing antibodies of Nanogam®plus

Secondary Outcome Measures

Name	Time	Method
? The incidence of COVID-19 during follow-up until antibody levels have become<br>undetectable<br>? Percentage of patients with adverse events after administration of convalescent<br>plasma<br>? Percentage of patients with adverse events after administration of Nanogam®plus