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

February 21, 2021 updated by: University of Zurich

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

58

Contacts and Locations

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

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8091
        • University Hospital Zurich

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

Probability Sample

Study Population

Patients with SARS-CoV-2 associated respiratory failure

Description

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 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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
SARS-CoV-2 associated respiratory failure
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.
Other: Questionnaires, spirometry
Questionnaires targeting health-related quality-of-life, symptoms, anxiety and depression

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health-related quality-of-life
Time Frame: 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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety and depression
Time Frame: 3 months
Hospital Axiety and Depression Score (HADS). Scoring: Scores range from 0 to 42, with higher scores indicating more anxiety or depression symptoms.
3 months
Symptom burden
Time Frame: 3 months
COPD Assessment Test (CAT). Scoring: Scores range from 0-40, with higher scores indicating more symptoms due to respiratory limitations.
3 months
Spirometry
Time Frame: 1 month
Forced expiratory volume in one second (FEV1) in liters and percent predicted.
1 month
Spirometry
Time Frame: 1 month
Forced vital capacity (FVC) in liters and percent predicted.
1 month

Collaborators and Investigators

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

Sponsor

University of Zurich

Investigators

  • Principal Investigator: Christian F Clarenbach, MD, University of Zurich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

June 3, 2020

Primary Completion (Actual)

February 17, 2021

Study Completion (Actual)

February 17, 2021

Study Registration Dates

First Submitted

April 24, 2020

First Submitted That Met QC Criteria

April 24, 2020

First Posted (Actual)

April 28, 2020

Study Record Updates

Last Update Posted (Actual)

February 23, 2021

Last Update Submitted That Met QC Criteria

February 21, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-00745

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

on reasonable request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on SARS-CoV 2

Clinical Trials on Questionnaires, spirometry

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burkina Faso

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe