Best available treatment study for inflammatory conditions associated with COVID-19

ABSTRACT

ConditionA spectrum of new inflammatory syndromes associated with COVID-19 (SARS-CoV-2 infection)
Infections and Infestations

Intervention
The researchers will study routinely collected non-identifiable data from patients presenting to hospitals worldwide with clearly defined clinical phenotypes.

Study size
The researchers anticipate recruitment of at least 1800 in total (150 cases from the UK, 50 from the host site). In the last month, since the establishment of a case definition in the UK (RCPCH 1 May 2020), over 100 cases have been reported across the UK and numbers are continuing to rise.

Recruitment process
Study information including clear guidance on which patients to enrol on the database and how to use the database will be disseminated across UK NHS hospital and internationally, through existing consortia and collaborations as well as international societies. If a centre wants to take part in the study, they will nominate a lead for their institution, who will be provided with user log-in details and a user guide for entering data onto the REDCap database. Paediatric doctors caring for children in emergency departments, wards or intensive care units will identify patients meeting the study criteria. The relevant patients can then be enrolled onto the REDCap database and data entered retrospectively.

Collection of clinical data
Data will be collected systematically on any patients meeting the study criteria using an online case report form. Patients will be anonymised and identified only by the clinician reporting the case. The severity of each patient’s clinical findings, inflammatory markers and organ dysfunction will be recorded on a daily basis before and after initiation of immunomodulating agents, or during observation (if no specific treatment given). Outcomes including, tim

Primary outcome:
Current primary outcome measures as of 08/04/2021
1. Composite Inotropic support or ventilation (invasive or non-invasive) at any time from the second day post-treatment or death at any time
2. Improvement on ordinal clinical severity scale at day 2 relative to day 0, comprising
2.1. Discharge on or before day 2 for any patient
2.2. Step down from ventilation/inotropic support/oxygen
2.3. Fall in CRP from >/= 50 to < 50 mg/l

Previous primary outcome measures:
1. Comparative effectiveness of different anti-inflammatory and immunomodulatory drugs in treating the inflammatory syndrome as measured by
1.1. Fall in blood inflammatory markers (CRP, pro-calcitonin, ferritin)
1.2. Prevention of cardiac dysfunction (left ventricular function on echocardiogram) and coronary artery aneurysms (z-scores of coronary arteries on echocardiogram)
1.3. Other long-term complications (any long-term disability not present on admission)

Data collected using an online case report form. Clinical data entered onto the online database will span the duration of each patient's hospital stay for that episode of illness.


CriteriaInclusion criteria
1. Any suspected case of inflammatory condition associated with SARS-CoV-2 in all ages
2. Data entry can be prospective or retrospective


Exclusion criteria There are no exclusion criteria