To identify differences in immune cell repertoire between pregnant women with critical COVID-19, mild COVID-19 and healthy controls.
ID
Source
Brief title
Condition
- Immunodeficiency syndromes
- Maternal complications of pregnancy
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Immune composition(B cell and plasma cell subsets, small clonal B cell
populations, innate cells, T cell subsets, cytokine profile; using the EuroFlow
panel and Luminex assay)
Secondary outcome
NA
Background summary
Data on SARS-CoV-2 infection in pregnant women are limited. Based on current
publications, the majority of pregnant women appears to have only mild symptoms
of COVID-19, but a small part develops severe symptoms and needs hospital or
Intensive Care Unit (ICU) admission. This particular group of patients may have
an insufficiency in their immune repertoire. Previous observations suggested
that abnormalities in the B cell compartment may predispose to an insufficiency
in the immunity to SARS-CoV-2.
Study objective
To identify differences in immune cell repertoire between pregnant women with
critical COVID-19, mild COVID-19 and healthy controls.
Study design
An observational single-centre case-control pilot study
Study burden and risks
Participating in this study will not yield direct benefits for the subjects.
However, it may be valuable for future patients by leading to new insights and
research directions for COVID-19. No additional risks or burden are expected
from the study (except for the negligible risks associated with a one-time
blood collection). If possible, blood collection may also be arranged at home.
Participation does not influence standard care procedures.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
Three groups of women will be eligible for inclusion in this pilot study:
1. COVID-19 during pregnancy: severe or critical disease
2. COVID-19 during pregnancy: mild disease
3. Healthy pregnant controls
4. COVID-19: non-pregnant women (from BEAT-COVID-1 study)
Mild, severe and critical disease are classified using the definitions of the
WHO (WHO: Clinical management of severe acute respiratory infection when
COVID-19 is suspected, March 13, 2020):
-mild disease: hospital interventions is not required, only symptomatic
treatment (such as antipyretics for fever) and monitoring
-severe disease: hospitalization and oxygen therapy is required
-critical disease: acute respiratory distress syndrome (ARDS), advanced
oxygen/ventilatory support is required
Inclusion criteria group 1
- Laboratory confirmation of SARS-CoV-2 infection
- Severe or critical disease
Group 2:
- Laboratory confirmation of SARS-CoV-2 infection
- Mild disease
- Similar maternal age and gestational age as one of the patients in group 1
(matched as accurately as possible)
Group 3:
- Similar maternal age and gestational age as one of the patients in group 1
(matched as accurately as possible)
Exclusion criteria
NA
Design
Recruitment
metc-ldd@lumc.nl
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 | NL74030.058.20 |