The ConvP COVig PKPD study: an investigation for the use of plasma or antibodies against the novel coronavirus (SARS-CoV-2)

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 PKPD study

Status

Not yet recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-000864-32-NL

Enrollment

104

Registered

2021-03-19

Start date

2021-03-29

Completion date

Unknown

Last updated

2021-07-05

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

Conditions

COVID-19 or protective effect against in B-cell depleted patients or vaccination non-responders MedDRA version: 23.1 Level: LLT Classification code 10084464 Term: COVID-19 immunization System Organ Class: 100000004865

Interventions

Trade Name: Nanogam 100 mg/ml Pharmaceutical Form: Solution for infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 18 years or older Written informed consent ? B-cell depleted status because one of following: o Prior B-cell depletion therapy (latest administration =65 years) yes F.1.3.1 Number of subjects for this age range 80

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 Known hypersensitivity to human immunoglobulins Liver cirrhosis Received anti-SARS-CoV-2 vaccination in the 2 weeks preceding screening or between screening and baseline

Design outcomes

Primary

Measure	Time frame
Secondary Objective: We will test this on patients with B-cell depletion and/or dysfunction or patients who are non-responder on vaccination. Because they are unable or hardly able to make neutralizing antibodies themselves, this could give them a protective effect against COVID19. Safety of convalescent plasma or nanogam will be evaluated;Primary end point(s): Main study parameter/endpoint • Duration and titers of virus neutralizing antibodies in serum of patients after the administration of different doses of ConvP • Duration and titers of virus neutralizing antibodies in serum of patients after the administration of different doses of Nanogam?plus ;Timepoint(s) of evaluation of this end point: Control of titer before administration of study product. One and 24 hours post-administration. on day 3 and 7 After 2, 4, 6, 8, 12, 18 and 24 weeks;Main Objective: To create a population pharmacokinetic model of SARS-COV-2 neutralizing antibodies as present in ConvP and Nanogam plus.	—

Measure

Time frame

Secondary Objective: We will test this on patients with B-cell depletion and/or dysfunction or patients who are non-responder on vaccination. Because they are unable or hardly able to make neutralizing antibodies themselves, this could give them a protective effect against COVID19. Safety of convalescent plasma or nanogam will be evaluated;Primary end point(s): Main study parameter/endpoint • Duration and titers of virus neutralizing antibodies in serum of patients after the administration of different doses of ConvP • Duration and titers of virus neutralizing antibodies in serum of patients after the administration of different doses of Nanogam?plus ;Timepoint(s) of evaluation of this end point: Control of titer before administration of study product. One and 24 hours post-administration. on day 3 and 7 After 2, 4, 6, 8, 12, 18 and 24 weeks;Main Objective: To create a population pharmacokinetic model of SARS-COV-2 neutralizing antibodies as present in ConvP and Nanogam plus.

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Secondary

Measure	Time frame
Secondary end point(s): • The incidence of COVID-19 during follow-up until antibody levels have become undetectable • Percentage of patients with adverse events (in particular TRALI of TACO) after administration of convalescent plasma • Percentage of patients with adverse events (in particular TRALI or TACO) 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. ;Timepoint(s) of evaluation of this end point: Control of titer before administration of study product. One and 24 hours post-administration. After 3 and 7 days After 2, 4, 6, 8, 12, 18 and 24 weeks	—

Measure

Time frame

Secondary end point(s): • The incidence of COVID-19 during follow-up until antibody levels have become undetectable • Percentage of patients with adverse events (in particular TRALI of TACO) after administration of convalescent plasma • Percentage of patients with adverse events (in particular TRALI or TACO) 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. ;Timepoint(s) of evaluation of this end point: Control of titer before administration of study product. One and 24 hours post-administration. After 3 and 7 days After 2, 4, 6, 8, 12, 18 and 24 weeks

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Countries

Netherlands

Contacts

Public ContactBart Rijnders

Erasmus MC

b.rijnders@erasmusmc.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026