A spectrum of new inflammatory syndromes associated with COVID-19 (SARS-CoV-2 infection) Infections and Infestations
Conditions
Interventions
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 r
Sponsors
Imperial College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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
Exclusion criteria: There are no exclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 08/04/2021: 1. Failure/escalation of primary treatment: 1.1. Addition of any immunomodulator from the first day after primary treatment 1.2. For patients receiving corticosteroids within primary treatment, an escalation of more than 5 mg/kg prednisolone equivalent in total daily dose 2. Time to one-level improvement in ordinal severity scale 3. Increase in level of support, based on death, or any commencement of: 3.1. ECMO for patients not on ECMO on day 0 3.2. Ventilation for patients not ventilated on day 0 3.3. Inotropic support for patients not ventilated on day 0 3.4. Oxygen for patients not on oxygen on day 0 4. Fever: presence of fever at any point from day 2 5. Persisting coronary artery dilatation: presence of a coronary artery with Lopez z-score = 2.5 or a report of aneurysm without z-score on the final echocardiogram, undertaken on the second or subsequent days following treatment 6. Left ventricular dysfunction: presence of left ventricular dysfunction on any echocardiogram 24 hours after commencement of primary immunomodulatory treatment. 7. Complications of drug therapy: Complications deemed by the treating clinician to be the result of immunomodulatory treatment, including but not limited to: allergy/anaphylaxis, cataracts, gastric perforation, gastric ulceration, hip necrosis, hyperglycaemia, hyperlactataemia, opportunistic infection, profound bradycardia, psychosis and steroid-induced hypertension Previous secondary outcome measures: 1. Proportion dying 2. Proportion requiring intensive/high dependency care 3. Total duration of fever 4. Risk of long-term complications (excluding CAA) 5. Proportion receiving any immunomodulator therapy 6. Proportion receiving individual immunomodulator classes 7. Total number of immunomodulators received per patient 8. Proportion with each organ system involved Data collected using an online case report form. Clinical data entered onto the online database will sp | — |
Countries
England, United Kingdom
Outcome results
None listed