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*plusSecondary…
ID
Source
Brief title
Condition
- Immune disorders NEC
- Viral infectious disorders
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
- 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.
Background summary
Standard treatment for the novel coronavirus is admission in hospital or even
ICU in case of common to severe disease. Even if we provide the most optimal
care, 20% of all patients who were admitted to the hospital eventually die.
Patients who have a weaker immune system have still higher risks. It is
necessary to search for better treatment options for patients with COVID19.
Antibodies from patients who have already recovered from the SARS-CoV-2 virus,
are probably effective to help other patients clear the virus. By giving this
treatment in the early phase of infection (before need of hospital admission),
disease progression, admission and even death by COVID could be avoided.
Antibodies are proteins made by our immune system if a patient is infected by a
virus with purpose of fighting against the virus. These antibodies are found in
the plasma. The immune system needs several days or weeks for production of
these antibodieis. Patients who already have had the virus infection, will have
those antibodies against SARS-CoV-2. Patients who are having early symptoms,
normally don't have those antibodies. Patients with a weakened immune system do
take longer for production of those antibodies, part of them never succeed in
producing them.
In this study we will give plasma containing antibodies against the coronavirus
coming from donors who already recovered from their infection or hyperimmune
antibodies to patients with underlying weakened immune system.
Previous studies in Hongkong in 2003 showed that patients who suffered a
SARS-CoV (1) virus recovered faster after administration of plasma coming from
patients who had already recovered.
Study objective
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
Study design
Multi-center, open label, phase I-II prospective, non-randomized trial
Intervention
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 (hyperimmune antibodies) coming from donors with
proven anti-SARS-CoV-2 antibodies.
Study burden and risks
Burden and risks are as followed:
- Half a day of admission in the hospital at the start of the study. After
this, patients should come to the hospital approx. 12 times (1x for screening +
blood sample + 1x for treatment and blood sample + 10x for blood samples)
- Burden of venapunction for blood samples and the risk of hematoma or pain
around place of punction
- Very low risk of severe adverse effect after administration of plasma (TRALI
or TACO)
- Very low risk of severe adverse effect after administration of Nanogam plus
(TRALI, TACO)
's-Gravendijkwal 230
Rotterdam 3015CE
NL
's-Gravendijkwal 230
Rotterdam 3015CE
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2021-000864-32-NL |
| CCMO | NL76798.078.21 |