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

NCT04365595 | Completed

• 1 other identifier: 2020-00745
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS-CoV 2; COVID

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Anxiety and depression

  3 months

• Symptom burden

  3 months

• Spirometry

  1 month

• Spirometry

  1 month

Study Arms (1)

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

Interventions

Questionnaires, spirometry OTHER

Questionnaires targeting health-related quality-of-life, symptoms, anxiety and depression

SARS-CoV-2 associated respiratory failure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with SARS-CoV-2 associated respiratory failure

You may qualify if:

• hospitalization at University Hospital Zurich due to COVID-19 infection
• hospital discharge max. 4 weeks ago
• requiring supplemental oxygen

You may not qualify if:

• \<18 years
• non-German speaking
• no smartphone access

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich

Zurich, 8091, Switzerland

Location

Related Publications (1)

• Kohlbrenner D, Kuhn M, Stussi-Helbling M, Nordmann Y, Spielmanns M, Clarenbach CF. Longitudinal Smartphone-Based Post-hospitalisation Symptom Monitoring in SARS-CoV-2 Associated Respiratory Failure: A Multi-Centre Observational Study. Front Rehabil Sci. 2021 Nov 24;2:777396. doi: 10.3389/fresc.2021.777396. eCollection 2021.

  PMID: 36188784 DERIVED

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Christian F Clarenbach, MD

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2020
• First Posted: April 28, 2020
• Study Start: June 3, 2020
• Primary Completion: February 17, 2021
• Study Completion: February 17, 2021
• Last Updated: February 23, 2021

Record last verified: 2021-02

Locations

CH (1)