Severe COVID-19 In Pregnancy (SCIP): a pilot study Linking disease severity to the maternal immune compositio
- Conditions
- Corona virusCOVID-19100214601002690810024970
- Registration Number
- NL-OMON49779
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 8
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)
NA
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Immune composition(B cell and plasma cell subsets, small clonal B cell<br /><br>populations, innate cells, T cell subsets, cytokine profile; using the EuroFlow<br /><br>panel and Luminex assay)</p><br>
- Secondary Outcome Measures
Name Time Method <p>NA</p><br>