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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON51004

Enrollment

104

Registered

2021-03-15

Start date

2021-05-17

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

corona virus COVID-19 SARS-CoV-2

Interventions

Infusion of convalescent plasma containing anti-SARS-CoV-2 antibodies (originatitng from donors with PCR-proven COVID-19 disease and recovered at least for 28 days). OR Infusion of Nanogam plus (

Eligibility

Age

18 Years to 99 Years

Inclusion 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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Duration and titer of neutralization antibodies in serum of patients after administration of different doses of convalescent plasma. Duration and titer of neutralization antibodies in serum of patients after administration of different doses 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 Nanogamplus Other study parameters (if applicable) - Whenever a breakthrough infection is diagnosed, we will do everything possible to collect the SARS-CoV-2 strain for sequencing in order to identify new or emerging variants of concern (e.g. strain 501.V2 or P.1 also known as the South-African or Brazilian variant) to evaluate the virus neutralizing capacity of the ConvP or Nanogamplus that the patient received.	—

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 Other study parameters (if applicable) - Whenever a breakthrough infection is diagnosed, we will do everything possible to collect the SARS-CoV-2 strain for sequencing in order to identify new or emerging variants of concern (e.g. strain 501.V2 or P.1 also known as the South-African or Brazilian variant) to evaluate the virus neutralizing capacity of the ConvP or Nanogam*plus that the patient received.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)