Risk Prediction and Therapy Monitoring in Patients With SARS-Cov-2 Infection / COVID 19
CROWNLESS
1 other identifier
observational
100
1 country
1
Brief Summary
Approximately 15% of patients with SARS-CoV-2 infection / COVID-19 develop a severe clinical course. This leads to hospitalization and potentially life threatening complications such as pneumonia and respiratory failure. Predictors for early detection and risk stratification are urgently needed. Moreover, only scarce information is available for long-term follow-up and late complications associated with infection. We therefore aimed to find predictors for severe courses of the novel disease as well as to establish strategies for therapeutic monitoring and follow-up.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2020
CompletedFirst Submitted
Initial submission to the registry
June 29, 2020
CompletedFirst Posted
Study publicly available on registry
July 2, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2022
CompletedJuly 2, 2020
June 1, 2020
2 years
June 29, 2020
June 30, 2020
Conditions
Outcome Measures
Primary Outcomes (6)
TLCO
Transfer factor for carbon monoxide
3-5 days intervals (inpatients)
TLCO
Transfer factor for carbon monoxide
1-6 months (outpatients, follow up)
D5-20
frequency dependence of resistance as measured by oscillometry
3-5 days intervals (inpatients
D5-20
frequency dependence of resistance as measured by oscillometry
1-6 months (outpatients, follow up)
FEV1/FVC
forced expiratory volume in 1 s / forced vital capacity (as measured by spirometry)
3-5 days intervals (inpatients)
FEV1/FVC
forced expiratory volume in 1 s / forced vital capacity (as measured by spirometry)
1-6 months (outpatients, follow up)
Secondary Outcomes (3)
comorbidities
at hospital admission and each follow (every 1-6 months)
clinical symptoms
3-5 days intervals (inpatients), 1-6 months (outpatients, follow up)
St. George's Respiratory Questionnaire total score
3-5 days intervals (inpatients), 1-6 months (outpatients, follow up)
Eligibility Criteria
Patients with SARS-CoV-2 infection / COVID 19
You may qualify if:
- SARS-CoV-2 infection / COVID 19
You may not qualify if:
- invasive ventilation
- respiratory failure at admission
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Thoraxklinik at Heidelberg University
Heidelberg, 69126, Germany
Study Officials
- PRINCIPAL INVESTIGATOR
Frederik Trinkmann, MD
Thoraxklinik at Heidelberg University
- STUDY DIRECTOR
Felix JF Herth, MD
Thoraxklinik at Heidelberg University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 29, 2020
First Posted
July 2, 2020
Study Start
April 1, 2020
Primary Completion
April 1, 2022
Study Completion
April 1, 2022
Last Updated
July 2, 2020
Record last verified: 2020-06