Evaluating Clinical Parameters of COVID-19 in Pregnancy
Evaluating Clinical Parameters of COVID-19 in Pregnancy
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.
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.
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).