COVID-19 and Corona infection
Conditions
Interventions
Intervention: three times daily (and if needed any additional) measurement of
oxygen saturation and pulse rate with a pulse oximeter as added to usual
(primary) care. Comparator: usual (primary) car
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1) Age *40 years 2) Cardiovasculair risk profile or cardiovascular disease (overweight, hypertension, diabetes, smoking, coronary artery disease, previous myocardial infarction, heart failure) 3) Presumably COVID-19 (both SARS-CoV-2 positive and non-COVID-19 confirmed patients) 4) Moderate-severe symptoms 5) Mentally competent
Exclusion criteria
Exclusion criteria: 1) Severe illness requiring hospital admission 2) Patient does not want future hospitalisation 3) Known anemia 4) Inadequate mastery of the Dutch language 5) Not willing to sign informed consent 6) Not willing to adhere to study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility defined as successful inclusion of 50 participants within 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| - the feeling of safety during the first two weeks of illness as reported by the patient - disability-free survival at 45 days (% change in WHODAS-2 between baseline and day 45) - number of days alive at home during 45 days after inclusion - time to discharge from medical follow-up (defined as last contact with healh care professional according to primary care electronic health record data) - number of primary care contacts during 45 days after inclusion - number of emergency care department visits during 45 days after inclusion - proportion of hospitalised patients within 45 days after inclusion - characteristics of hospital admissions within 45 days after inclusion o clinical profile at time of hospitalisation (according to the warning signs of Dutch College of General Practitioners) o length of stay (total and stratified into ward and ICU) o proportion of patients admitted to ICU o type of treatments - 45 day mortality o overall mortality o out-of-hospital mortality o in-hospital mortality In a parallel process evaluation, we will examine: - how the intervention has been used in practice in terms of: (i) Fidelity - whether the intervention was carried out as planned; (ii) Dose - whether the intervention has been used as long and frequently as planned; (iii) Adjustments - whether adjustments have been made to the intervention and why; (iv) Reach - whether the intended audience has been reached and - the experiences of patients in the intervention group and their informal caregivers in terms of disease perception, fear and use of the intervention - GPs' experiences with the intervention (usability of pulseoximetry as diagnostic procedure and impact on healthcare utilization) To determine the expression of Neprilysin/CD10 on neutrophil granulocytes in the blood of study participants and to explore its predictive value in terms of clinical deterioration in COVID-19 patients and whether this expression is associated with prolonged sy | — |
Countries
Netherlands
Outcome results
None listed