PROTEGO: PRospective Observational cohort Trial Evaluating correlation of clinical findings, symptoms and disease development of German in- or Outpatients infected with SARS-CoV-2 - a CHIR-Net Student-Initiated German Medical Audit trial COVID-19 study (CHIR-Net SIGMA study group)
- Conditions
- SARS-CoV-2 infectionCOVID-19 diseaseU07.1COVID-19, virus identified
- Registration Number
- DRKS00021226
- Lead Sponsor
- niversitätsklinikum Heidelberg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 500
Inclusion Criteria
1.Age = 18 years
2.SARS-CoV-2 infection confirmed in molecular testing
3.Ability of the patient to understand the character and individual consequences of the study
4.Informed consent
Exclusion Criteria
Patients with a legal guardian
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. SARS-CoV-2 infection associated symptoms<br>2. COVID-19 associated complications<br>3. Health-related quality of life according to EQ-5D <br>4. Depression and anxiety measured via the HADS-D<br>5. In case of hospital admission:<br>a.Rate of hospital admissions <br>b.Rate of Intensive Care Unit admissions<br>c.Length of hospital stay in days<br>d.Imaging results <br>e.Need of mechanical ventilation<br>f.Need of cardiovascular support<br>g.SARS-CoV-2 associated lab parameters<br>6.Health economic outcome measures:<br>a.Time to recovery,<br>b.Influence on work<br>7.Overall mortality <br>8.SARS-CoV-2 associated mortality
- Secondary Outcome Measures
Name Time Method