Risk Prediction and Therapy Monitoring in Patients With SARS-Cov-2 Infection / COVID 19

COVID Clinical Trial

— CROWNLESS  

Official title:

Risk Prediction and Therapy Monitoring in Patients With SARS-Cov-2 Infection / COVID 19

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04456075
• Other study ID #: CROWNLESS
• Status: Recruiting
• Start date: April 1, 2020
• Est. completion date: April 2022

Study information

• Verified date: June 2020
• Source: Heidelberg University
• Contact: Frederik Trinkmann, MD
• Phone: +49 6221 396
• Email: frederik.trinkmann[@]med.uni-heidelberg.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• SARS-CoV-2 infection / COVID 19

Exclusion Criteria:

• invasive ventilation

• respiratory failure at admission

Related Conditions & MeSH terms

• COVID
• Infection
• SARS-CoV2

Locations

Country	Name	City	State
Germany	Thoraxklinik at Heidelberg University	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TLCO	Transfer factor for carbon monoxide	3-5 days intervals (inpatients)
Primary	TLCO	Transfer factor for carbon monoxide	1-6 months (outpatients, follow up)
Primary	D5-20	frequency dependence of resistance as measured by oscillometry	3-5 days intervals (inpatients
Primary	D5-20	frequency dependence of resistance as measured by oscillometry	1-6 months (outpatients, follow up)
Primary	FEV1/FVC	forced expiratory volume in 1 s / forced vital capacity (as measured by spirometry)	3-5 days intervals (inpatients)
Primary	FEV1/FVC	forced expiratory volume in 1 s / forced vital capacity (as measured by spirometry)	1-6 months (outpatients, follow up)
Secondary	comorbidities	structured questionnaire	at hospital admission and each follow (every 1-6 months)
Secondary	clinical symptoms	structured qualitative questionnaire	3-5 days intervals (inpatients), 1-6 months (outpatients, follow up)
Secondary	St. George's Respiratory Questionnaire total score	validated questionnaire (scores range from 0 to 100, with higher scores indicating more limitations)	3-5 days intervals (inpatients), 1-6 months (outpatients, follow up)