SARS-CoV-2 Associated Respiratory Failure Recovery (COVID-19 CAir)

COVID Clinical Trial

Official title:

Recovery in Patients With SARS-CoV-2 Associated Respiratory Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04365595
• Other study ID #: 2020-00745
• Status: Completed
• Start date: June 3, 2020
• Est. completion date: February 17, 2021

Study information

• Verified date: February 2021
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the cause of the current pandemic of coronavirus disease (COVID-19) that can lead to respiratory failure requiring oxygen therapy. Some patients develop acute respiratory distress syndrome (ARDS) and may die despite intensive care therapy. Currently it is unknown a) how fast patients recover after being discharged from hospital and b) what underlying predictors may influence recovery.

Description:

Study aims:

• To evaluate subjective and objective recovery after discharge from hospital in patients with respiratory failure due to COVID-19.

• To identify risk factors for COVID-19 associated respiratory failure and prolonged recovery

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: February 17, 2021
• Est. primary completion date: February 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• hospitalization at University Hospital Zurich due to COVID-19 infection

• hospital discharge max. 4 weeks ago

• requiring supplemental oxygen

Exclusion Criteria:

• <18 years

• non-German speaking

• no smartphone access

Related Conditions & MeSH terms

• COVID
• Respiratory Insufficiency
• SARS-CoV 2

Intervention

Other:
• Questionnaires, spirometry
Questionnaires targeting health-related quality-of-life, symptoms, anxiety and depression

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health-related quality-of-life	European Quality of Life - 5 Dimensions - 5 Levels Instrument (EQ-5D-5L). Scoring: Index ranges from 1 to <0, with lower scores indicating more limitations.	3 months
Secondary	Anxiety and depression	Hospital Axiety and Depression Score (HADS). Scoring: Scores range from 0 to 42, with higher scores indicating more anxiety or depression symptoms.	3 months
Secondary	Symptom burden	COPD Assessment Test (CAT). Scoring: Scores range from 0-40, with higher scores indicating more symptoms due to respiratory limitations.	3 months
Secondary	Spirometry	Forced expiratory volume in one second (FEV1) in liters and percent predicted.	1 month
Secondary	Spirometry	Forced vital capacity (FVC) in liters and percent predicted.	1 month