Evaluating Clinical Parameters of COVID-19 in Pregnancy

• Conditions: COVID-19; 2019 Novel Coronavirus Infection; COVID-19 Infection

• Registration Number: NCT04470583
• Lead Sponsor: Chelsea and Westminster NHS Foundation Trust

Brief Summary

Coronavirus infection, also known as COVID-19, has become a global pandemic with over 3 million cases and 250,000 deaths worldwide. Coronaviruses (CoV) belong to a family of viruses that predominately infect mammals and birds, affecting their lungs, intestinal tract, liver and nervous systems. Prior to the discovery of the current novel coronavirus strain (SARS-CoV-2), there were six different strains that are known to infect humans, which includes the virus that caused the severe acute respiratory syndrome (SARS) pandemic in 2002. In humans, the majority of severe illness from SARs and COVID-19 is due to inflammation of the lungs and pneumonia. Pregnancy poses a significantly increased risk of viral pneumonia and during SARS more pregnant women required intensive care and breathing support, and the proportion of deaths was higher when compared to non-pregnant adults. Furthermore, kidney failure and development of abnormal blood clotting disorders, which occurs during severe infection, is more common in pregnancy and the associated changes in blood vessels extend to the placentas of infected pregnant women, thus potentially affecting the fetus. This makes pregnant women affected by the virus at high risk of developing severe complications. Fortunately, there have been a number of biomarkers identified that are associated with illness severity. These include, specialised white blood cells, blood clotting cells and constituents, as well as other measures of heart and kidney function. We propose that these biomarkers are important correlates of clinical disease severity and prognosis in pregnant and postnatal women. This knowledge has the potential to help clinicians during this pandemic to better manage and care for their patients.

Detailed Description

This study will be a retrospective case review using existing clinical data from participating centres. To date there have already been 18,000 confirmed cases in Greater London. Our study design will aim to include patients who were diagnosed with COVID-19 at the start of the pandemic as well as new and current cases.

The study design requires data to be extracted from National Health Service (NHS) electronic and paper notes, which will contain patient identifiable information. For confidentiality, all patient identifiable data will only be collected by members of the direct care team. This data will be encrypted and stored in a local NHS trust computer at participating sites. In order to maintain confidentiality, all data will then be anonymised before being inputted on a data collection tool and spreadsheet. Therefore, research teams will only be provided with a de-identified dataset. This data will be transferred across to the study co-ordination centre, following NHS information governance rules for data to be compiled and analysed. At the co-ordination centre, this data will be stored in an Imperial College London computer, and will only be accessible to the research team.

Study Timeline

• Study First Submitted: 2020-07-13
• Study First Submitted QC: 2020-07-13
• Study First Posted: 2020-07-14
• Status Verified: 2020-10
• Study Start: 2020-10-09
• Last Update Submitted: 2020-10-09
• Last Update Posted: 2020-10-12
• Primary Completion: 2021-11
• Study Completion: 2021-12-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

• COVID-19 infection
• 18-50 years for Groups A and B and 18-60 years for Groups C and D
• Female for groups A and B. Both male and female for groups C and D.

Exclusion Criteria

• Participants who have previously been part of a SARS-CoV-2 vaccine trial.
• Current hospital admission due to another respiratory disease, such as influenza.
• Obvious clinical deterioration due to another medical problem such as cardiovascular disease, diabetes or malignancy.
• Evidence of HIV infection and/or participants on anti-retroviral drug therapy.
• Participants on chemotherapy, biologics, immune-modulators or immunosuppressive drugs (not including intramuscular steroids for fetal lung maturity).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportions of leukocyte subsets and thrombocytes in pregnant/postnatal and non-pregnant COVID-19 positive women.	From the start of the study up until one month prior to study end.	Data collection and analysis on the proportions of leukocyte subsets and thrombocytes in pregnant/postnatal and non-pregnant COVID-19 positive patients during acute infection and recovery.
Concentrations of other biochemical markers of severity in pregnant and non-pregnant COVID-19 positive women.	From the start of the study up until one month prior to study end.	Data collection and analysis on the concentrations of other biochemical markers of severity in pregnant and non-pregnant COVID-19 positive patients during acute infection and recovery.

Secondary Outcome Measures

Name	Time	Method
Profiling of clinical severity, determined by clinical symptoms and observations in pregnant and non-pregnant COVID-19 positive women.	From the start of the study up until one month prior to study end.	Data collection and analysis on profiling of clinical severity, determined by clinical symptoms and observations in pregnant and non-pregnant COVID-19 positive women.

Trial Locations

Locations (2)

Chelsea and Westminster Hospital NHS Foundation Trust; 🇬🇧 London, United Kingdom

Chelsea and Westminster Hospital; 🇬🇧 London, United Kingdom