To describe to early stage SARS-CoV-2 immune response including antibody kinetics in patients with mild COVID-19 symptoms who were not admitted to the hospital.
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The geometric mean titres of total and isotype-specific (including IgM, IgG)
antibodies in patients with mild COVID-19 symptoms which did not require
hospital admittance.
Secondary outcome
none.
Background summary
A large part of the population will eventually experience the coronavirus.
Majorty of these people will hardly experience any complaints. It is important
to investigate how our immune system responds to getting COVID-19 and
preferably to determine this as early as possible. In particular, by looking at
this early stage.
Study objective
To describe to early stage SARS-CoV-2 immune response including antibody
kinetics in patients with mild COVID-19 symptoms who were not admitted to the
hospital.
Study design
A prospective cohort study will be conducted at the Amsterdam Rheumatology &
immunology Center, location Reade. The follow-up duration for participants will
be 6 months. After a baseline visit, additional visits are planned between 3-5
days, between 6-7 days, 11-12 days, 1 month and at 3 and 6 months. At each
visit blood will be drawn. The study is expected to cover 10 months for
recruitment, follow-up and analysis
Study burden and risks
This study is relevant for clinical practice, especially since the COVID-19
pandemic provides a unique opportunity to provide insight in the early
antibody/immune response in patients with mild COVID-19 symptoms who do not
require hospital admittance and aid in assessing the performance of the assay
in this patient category. Approaching healthy volunteers during the early stage
of COVID-19 infection is therefore essential since most sero-surveillance
studies will be performed in a similar population. This study will therefore be
highly relevant.
Disadvantages for participants will be that blood withdrawal will take place 7
times during the study. The risk of drawing blood is negligible.
Dr. Jan van Bremenstraat 2
Amsterdam 1056 AB
NL
Dr. Jan van Bremenstraat 2
Amsterdam 1056 AB
NL
Listed location countries
Age
Inclusion criteria
1. Age > 18 years;
2. Symptoms associated with a COVID-19 infection;
3. Travelled to an endemic region or have contact with a person who is
suspected for/or diagnosed with a COVID-19 infection or had a SARS-CoV-2
positive PCR;
4. Mild COVID-19 symptoms which did not require hospital admittance;
5. No more than 10 days between symptoms associated with a COVID-19 infection
and the screening visit.
Exclusion criteria
1. Language problems precluding the completion of the questionnaire or
understanding the informed consent;
2. Likelihood of absence in the next 4 weeks.
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 | NL73926.029.20 |