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

Completed

• Conditions: SARS-CoV 2; COVID
• Interventions: Other: Questionnaires, spirometry

• Registration Number: NCT04365595
• Lead Sponsor: University of Zurich

Brief 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.

Detailed 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

Study Timeline

• Study First Submitted: 2020-04-24
• Study First Submitted QC: 2020-04-24
• Study First Posted: 2020-04-28
• Study Start: 2020-06-03
• Status Verified: 2021-02
• Primary Completion: 2021-02-17
• Study Completion: 2021-02-17
• Last Update Submitted: 2021-02-21
• Last Update Posted: 2021-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SARS-CoV-2 associated respiratory failure	Questionnaires, spirometry	Participants will receive a daily HrQoL questionnaire on their personal smartphone using the docdok health application during 3 months. A selection of participants will furthermore receive a custom-built home disease monitoring device during 1 month. Both procedures start at least 4 weeks after hospital discharge.

Primary Outcome Measures

Name	Time	Method
Health-related quality-of-life	3 months	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.

Secondary Outcome Measures

Name	Time	Method
Anxiety and depression	3 months	Hospital Axiety and Depression Score (HADS). Scoring: Scores range from 0 to 42, with higher scores indicating more anxiety or depression symptoms.
Symptom burden	3 months	COPD Assessment Test (CAT). Scoring: Scores range from 0-40, with higher scores indicating more symptoms due to respiratory limitations.
Spirometry	1 month	Forced vital capacity (FVC) in liters and percent predicted.

Trial Locations

Locations (1)

University Hospital Zurich; 🇨🇭 Zurich, Switzerland