CovidCare 1 – Surveillance and care for confirmed and suspected patients with COVID-19 in general practice: an observational study
- Conditions
- 07.1 COVID-19U07.2 Suspicion of COVID-19
- Registration Number
- DRKS00022054
- Lead Sponsor
- niversitätsklinikum Heidelberg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 200
1. COVID-19 patients aged 18 or older (as per definition patients with symptoms of an infect of any severity and positive test for SARS-CoV-2), who are in domestic isolation* and who have at least one risk factor*
OR
2. Patients aged 50 and older with a clinically urgent suspicion of COVID-19 (such as acute respiratory symptoms of any severity), without verification of SARS-CoV-2 and who have at least one risk factor**/***
*Domestic isolation: includes persons for whom the authorities highly recommend further social distancing beyond the restrictions as currently ordered until April 20th 2020.
**This criterium might by subject to potential changes and might be further adapted according to a) the current epidemiological situation, b) the requirements of the RKI, c) the test strategy as well as d) the test capacity.
***Risk factors following the definition by the RKI, with own additions:
- Diabetes mellitus (Types I and II)
- Cardiovascular disease (arterial hypertension, coronary heart disease, heart failure, other such as atrial fibrillation, peripheral artery disease, condition after apoplexy)
- Pulmonary disease (COPD, bronchial asthma, other)
- chronical nephrological disease
- chronical hepatic disease such as liver cirrhosis
- immunodeficiency due to underlying disease (malignant primary hematological disease (e.g. leukemia/ lymphoma), leukocyptopenia, condition after organ or stem cell transplantation or potentially immunosuppressive medication intake such as glucocorticoids, immunosuppressive drugs, immunomodulators, cytostatics
- active oncological disease with immunodeficiency (excluding for example localized skin cancer such as squamous cell carcinoma or basal cell carcinoma)
- obesity (body mass index > 35)
- active smoking
- down syndrome
incapability of informed consent
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hospitalization due to COVID-19
- Secondary Outcome Measures
Name Time Method 1. Diagnosis of pneumonia in confirmed and suspected COVID-19 patients<br>2. Utilization of palliative care by confirmed and suspected COVID-19 patients during quarantine or stay at hospital<br>3. Mortality rate of confirmed and suspected COVID-19 patients (death at home, death in hospital, death in long-term care institution)<br>4. Anxiety in confirmed and suspected COVID-19 patients using the Generalized Anxiety Disorder Index (GAD-2)<br>5. Identification of predictive risk factors for the outcomes such as hospitalization, intensive care and mortality