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

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ClinicalTrials.gov Identifier: NCT04456075
Recruitment Status : Recruiting
First Posted : July 2, 2020
Last Update Posted : July 2, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. Frederik Trinkmann, Heidelberg University

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.

Condition or disease
SARS-CoV2 COVID

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Risk Prediction and Therapy Monitoring in Patients With SARS-Cov-2 Infection / COVID 19
Actual Study Start Date : April 1, 2020
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. TLCO [ Time Frame: 3-5 days intervals (inpatients) ]
    Transfer factor for carbon monoxide

  2. TLCO [ Time Frame: 1-6 months (outpatients, follow up) ]
    Transfer factor for carbon monoxide

  3. D5-20 [ Time Frame: 3-5 days intervals (inpatients ]
    frequency dependence of resistance as measured by oscillometry

  4. D5-20 [ Time Frame: 1-6 months (outpatients, follow up) ]
    frequency dependence of resistance as measured by oscillometry

  5. FEV1/FVC [ Time Frame: 3-5 days intervals (inpatients) ]
    forced expiratory volume in 1 s / forced vital capacity (as measured by spirometry)

  6. FEV1/FVC [ Time Frame: 1-6 months (outpatients, follow up) ]
    forced expiratory volume in 1 s / forced vital capacity (as measured by spirometry)


Secondary Outcome Measures :
  1. comorbidities [ Time Frame: at hospital admission and each follow (every 1-6 months) ]
    structured questionnaire

  2. clinical symptoms [ Time Frame: 3-5 days intervals (inpatients), 1-6 months (outpatients, follow up) ]
    structured qualitative questionnaire

  3. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with SARS-CoV-2 infection / COVID 19
Criteria

Inclusion Criteria:

  • SARS-CoV-2 infection / COVID 19

Exclusion Criteria:

  • invasive ventilation
  • respiratory failure at admission

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04456075


Contacts
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Contact: Frederik Trinkmann, MD +49 6221 396 ext 1201 frederik.trinkmann@med.uni-heidelberg.de

Locations
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Germany
Thoraxklinik at Heidelberg University Recruiting
Heidelberg, Germany, 69126
Contact: Frederik Trinkmann, MD    + 49 6221 396 ext 1201    frederik.trinkmann@med.uni-heidelberg.de   
Sponsors and Collaborators
Heidelberg University
Investigators
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Principal Investigator: Frederik Trinkmann, MD Thoraxklinik at Heidelberg University
Study Director: Felix JF Herth, MD Thoraxklinik at Heidelberg University
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Responsible Party: Dr. Frederik Trinkmann, Principal Investigator, Heidelberg University
ClinicalTrials.gov Identifier: NCT04456075    
Other Study ID Numbers: CROWNLESS
First Posted: July 2, 2020    Key Record Dates
Last Update Posted: July 2, 2020
Last Verified: June 2020
Additional relevant MeSH terms:
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COVID-19
Infections
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases