The primary objective (1) of the proposed study is to isolate and characterize neutralizing monoclonal antibodies from patients who recovered from COVID-19 infection. The secondary objective (2) is to isolate and characterize monoclonal antibodies…
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
For objective 1, the main endpoints are the percentage COVID-19 spike protein
positive memory B cells and the neutralization potency of monoclonal antibodies
derived from COVID-19 spike protein positive memory B cells. For objective 2
the main endpoint are the percentage Coronavirus (CoV) cross-reactive memory B
cells and the neutralization potency and breadth of monoclonal antibodies
derived from CoV cross-reactive memory B cells.
Secondary outcome
NA
Background summary
Coronavirus disease 2019 (COVID-19) is caused by the coronavirus SARS-CoV-2
(hereafter named *COVID-19* virus) and is a rapidly spreading epidemic. Upon
infection, COVID-19 is accompanied with a significant morbidity and mortality
among those who are infected. Currently, there are no specific treatment
options available. In Ebola virus, respiratory syncytial virus (RSV), rabies
and others neutralizing antibodies were effective in treatment and prevention
of infection. In combination with the low viral diversity of COVID-19 and known
antibody responses in COVID-19 patients, we hypothesize that the isolation of
COVID-19-specific antibodies may provide an avenue for prevention and treatment
of COVID-19.
Study objective
The primary objective (1) of the proposed study is to isolate and characterize
neutralizing monoclonal antibodies from patients who recovered from COVID-19
infection. The secondary objective (2) is to isolate and characterize
monoclonal antibodies with broadly neutralizing activity against other
coronaviruses or SARS-CoV-2 variants.
Study design
Study design: The study is designed as an observational study
Methods: In patients who were diagnosed with a COVID-19 infection, at 3-8 weeks
after occurrence of first symptoms, a sample of 65 mL blood will be drawn. The
blood samples will be transferred to and handled in the HIV lab of the
department of medical microbiology according to standardized protocols and as
part of ongoing work on antibody responses in HIV-1 infection. In case the
nasopharyngeal swab of diagnosis is not readily available, a new nasopharyngeal
swab is performed early in the disease.
Study burden and risks
The risk of sampling (one blood draw) is considered minimal. There is no direct
benefit of participation in the study for the patient. Regarding group
relatedness, the sampling is considered to be necessary since it is the only
approach to isolate COVID-specific monoclonal antibodies that may in the future
be a potential source for therapy in similar patients.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
-written informed consent to participate in the study and store samples
-age between 18 and 75 years
- PCR confirmed SARS-CoV-2 infection
- able to visit the Amsterdam UMC, location AMC 3-8 weeks after onset of
COVID-19 symptoms. In the absence of symptoms, patients will visit the
Amsterdam UMC, location AMC 3-8 weeks after PCR confirmation. A home visit by
the study team is a possibility when the patient is unable to travel to the
Amsterdam UMC.
Exclusion criteria
-mental disorder that in the view of the investigator would interfere with
adherence to the treatment or the study procedures, or the decision to
participate in the study.
-use of immunosuppressive medication (equivalent of > 7.5mg prednisolone /
day). Note: Patients with only a short course of immunosuppressive medication
can still participate.
Design
Recruitment
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 |
|---|---|
| CCMO | NL73281.018.20 |