Primary Objective: • To create a population pharmacokinetic model of SARS-COV-2 neutralizing antibodies as present in ConvP. • To create a population pharmacokinetic model of SARS-COV-2 neutralizing antibodies as present in Nanogam plus Secondary…
ID
Bron
Verkorte titel
Aandoening
COVID-19
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
● Pharmacokinetics of virus neutralizing antibodies of ConvP
● Pharmacokinetics of virus neutralizing antibodies of Nanogam®plus
Achtergrond van het onderzoek
Convalescent plasma (ConvP) from recovered COVID-19 patients has been used as a form of treatment against COVID-19 across the globe. However, more than a year into the pandemic, proper dose finding studies are still lacking and its effectivity as a therapy for certain COVID-19 subpopulations remains to be proven by large well designed clinical trials. More recently 2 batches of intravenous immunoglobulins (IVIG) produced from a large pool of ConvP donors were produced by Sanquin Plasma Products B.V. (SPP). As a result of the donor selection process, this IVIG solution (Nanogam®) contains high titers of SARS-CoV-2
neutralizing antibodies and is informally called Nanogam®plus. Compared to ConvP, Nanogam®plus has the advantage of smaller volumes, higher antibody titers, no dose variation and no need for ABO blood group matching. Patients who lack B-cell immunity (by dysfunction or depletion) are at a higher risk for poor outcome and death in case of COVID-19 disease and will have limited or no benefit from vaccination. In these patients ConvP or Nanogam®plus could be used as a prophylactic therapy to protect them from COVID-19 until cohort immunity is present. Below we describe a fase I-II dose finding study of ConvP and Nanogam®plus in B-cell depleted patients with emphasis on pharmacokinetics and exploration on protective effects of antibodies.
Doel van het onderzoek
Primary Objective:
• To create a population pharmacokinetic model of SARS-COV-2 neutralizing antibodies as present in ConvP.
• To create a population pharmacokinetic model of SARS-COV-2 neutralizing antibodies as present in Nanogam
plus
Secondary Objective(s):
• To evaluate the protective potential against COVID-19 in B-cell depleted patients receiving Nanogam
plus or ConvP
• Evaluate the safety of ConvP and Nanogam
plus
Onderzoeksopzet
Evalutation of patient serum on D0; +1 hour; 3, 7, 14, 28 days; 6, 8, 12, 18, 24 weeks
Onderzoeksproduct en/of interventie
Infusion of convalescent plasma or Nanogam plus (IVIG-therapy containing anti-SARS-CoV-2 antibodies)
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL9379 |
| Ander register | METC Erasmus MC : MEC-2021-0163 |