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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)

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) - PROTEGO

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00021226
Enrollment
500
Registered
2020-05-04
Start date
2020-05-07
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SARS-CoV-2 infection COVID-19 disease U07.1

Interventions

Group 1: Symptoms, clinical course, complications, psychological situation twice a week until recovery in patients infected with SARS-CoV-2 confirmed by molecular diagnostics

Sponsors

Universitätsklinikum Heidelberg
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

Exclusion criteria: Patients with a legal guardian

Design outcomes

Primary

MeasureTime frame
1. SARS-CoV-2 infection associated symptoms 2. COVID-19 associated complications 3. Health-related quality of life according to EQ-5D 4. Depression and anxiety measured via the HADS-D 5. In case of hospital admission: a.Rate of hospital admissions b.Rate of Intensive Care Unit admissions c.Length of hospital stay in days d.Imaging results e.Need of mechanical ventilation f.Need of cardiovascular support g.SARS-CoV-2 associated lab parameters 6.Health economic outcome measures: a.Time to recovery, b.Influence on work 7.Overall mortality 8.SARS-CoV-2 associated mortality

Countries

Germany

Contacts

Public ContactAndré Mihaljevic

Klinik für Allgemein-, Viszeral- und TransplantationschirurgieUniversitätsklinikum Heidelberg

andre.mihaljevic@med.uni-heidelberg.de06221-5636986

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026