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Clinical Trials/NCT04456075
NCT04456075
Unknown
Not Applicable

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

Heidelberg University1 site in 1 country100 target enrollmentApril 1, 2020
ConditionsSARS-CoV2COVID

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
SARS-CoV2
Sponsor
Heidelberg University
Enrollment
100
Locations
1
Primary Endpoint
D5-20
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2020
End Date
April 2022
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Frederik Trinkmann

Principal Investigator

Heidelberg University

Eligibility Criteria

Inclusion Criteria

  • SARS-CoV-2 infection / COVID 19

Exclusion Criteria

  • invasive ventilation
  • respiratory failure at admission

Outcomes

Primary Outcomes

D5-20

Time Frame: 1-6 months (outpatients, follow up)

frequency dependence of resistance as measured by oscillometry

FEV1/FVC

Time Frame: 1-6 months (outpatients, follow up)

forced expiratory volume in 1 s / forced vital capacity (as measured by spirometry)

TLCO

Time Frame: 1-6 months (outpatients, follow up)

Transfer factor for carbon monoxide

Secondary Outcomes

  • 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))

Study Sites (1)

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