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

June 30, 2020 updated by: Dr. Frederik Trinkmann, Heidelberg University
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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with SARS-CoV-2 infection / COVID 19

Description

Inclusion Criteria:

  • SARS-CoV-2 infection / COVID 19

Exclusion Criteria:

  • invasive ventilation
  • respiratory failure at admission

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TLCO
Time Frame: 3-5 days intervals (inpatients)
Transfer factor for carbon monoxide
3-5 days intervals (inpatients)
TLCO
Time Frame: 1-6 months (outpatients, follow up)
Transfer factor for carbon monoxide
1-6 months (outpatients, follow up)
D5-20
Time Frame: 3-5 days intervals (inpatients
frequency dependence of resistance as measured by oscillometry
3-5 days intervals (inpatients
D5-20
Time Frame: 1-6 months (outpatients, follow up)
frequency dependence of resistance as measured by oscillometry
1-6 months (outpatients, follow up)
FEV1/FVC
Time Frame: 3-5 days intervals (inpatients)
forced expiratory volume in 1 s / forced vital capacity (as measured by spirometry)
3-5 days intervals (inpatients)
FEV1/FVC
Time Frame: 1-6 months (outpatients, follow up)
forced expiratory volume in 1 s / forced vital capacity (as measured by spirometry)
1-6 months (outpatients, follow up)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
comorbidities
Time Frame: at hospital admission and each follow (every 1-6 months)
structured questionnaire
at hospital admission and each follow (every 1-6 months)
clinical symptoms
Time Frame: 3-5 days intervals (inpatients), 1-6 months (outpatients, follow up)
structured qualitative questionnaire
3-5 days intervals (inpatients), 1-6 months (outpatients, follow up)
St. George's Respiratory Questionnaire total score
Time Frame: 3-5 days intervals (inpatients), 1-6 months (outpatients, follow up)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heidelberg University

Investigators

  • Study Director: Felix JF Herth, MD, Thoraxklinik at Heidelberg University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2020

Primary Completion (Anticipated)

April 1, 2022

Study Completion (Anticipated)

April 1, 2022

Study Registration Dates

First Submitted

June 29, 2020

First Submitted That Met QC Criteria

June 30, 2020

First Posted (Actual)

July 2, 2020

Study Record Updates

Last Update Posted (Actual)

July 2, 2020

Last Update Submitted That Met QC Criteria

June 30, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CROWNLESS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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