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Severe COVID-19 In Pregnancy (SCIP): a pilot study Linking disease severity to the maternal immune composition

Severe COVID-19 In Pregnancy (SCIP): a pilot study Linking disease severity to the maternal immune composition - SCIP pilot study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON49779
Enrollment
8
Registered
2020-09-07
Start date
2020-10-01
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Corona virus COVID-19

Interventions

None listed

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: NA

Design outcomes

Primary

MeasureTime frame
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)

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)