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

Completed

• Conditions: corona virus; COVID-19; SARS-CoV-2; 10027665; 10047438; 10024970

• Registration Number: NL-OMON51004
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Trial is onging in other countries

Detailed Description

Not available

Study Timeline

• Study Completion: 2024-03-19
• Results First Posted: 2024-03-19
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 44

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
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

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
baseline

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Duration and titer of neutralization antibodies in serum of patients after<br /><br>administration of different doses of convalescent plasma.<br /><br><br /><br>Duration and titer of neutralization antibodies in serum of patients after<br /><br>administration of different doses of Nanogam plus.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- The incidence of COVID-19 during follow-up until antibody levels have become<br /><br>undetectable<br /><br><br /><br>- Percentage of patients with adverse events after administration of<br /><br>convalescent plasma<br /><br><br /><br>- Percentage of patients with adverse events after administration of<br /><br>Nanogam*plus<br /><br>Other study parameters (if applicable)<br /><br><br /><br>- Whenever a breakthrough infection is diagnosed, we will do everything<br /><br>possible to collect the SARS-CoV-2 strain for sequencing in<br /><br>order to identify new or emerging variants of concern (e.g. strain 501.V2 or<br /><br>P.1 also known as the South-African or Brazilian variant) to evaluate<br /><br>the virus neutralizing capacity of the ConvP or Nanogam*plus that the patient<br /><br>received.</p><br>