NCT04565106

Brief Summary

Patients with coronavirus disease (COVID-19) and pneumonitis often have hypoxemic respiratory failure and a need of supplementary oxygen. Guidelines recommend controlled oxygen, for most patients with a recommended interval of SpO2 between 92 and 96 %. We aimed to determine if closed-loop control of oxygen was feasible in patients with COVID-19 and could maintain SpO2 in the specified interval.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 25, 2020

Completed
Last Updated

September 25, 2020

Status Verified

September 1, 2020

Enrollment Period

2 months

First QC Date

September 24, 2020

Last Update Submit

September 24, 2020

Conditions

Covid19Hypoxemic Respiratory FailureHypoxemia

Keywords

O2maticClosed-loop

Outcome Measures

Primary Outcomes (1)

  • Time in SpO2 target

    Time in SpO2 target of 92-96 %

    1 week

Secondary Outcomes (3)

  • Time with SpO2 not more than 2 % outside target

    1 week

  • Time with SpO2 more than 2 % outside target

    1 week

  • Time with SpO2 < 85 %

    1 week

Interventions

Closed-loop control of oxygen supplementation by O2maticDEVICE

Closed-loop control of oxygen supplementation to achieve a target SpO2 of 92 - 96 %

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted with COVID-19 pneumonitis and in need of oxygen supplementation

You may qualify if:

  • Older than 18 years
  • Positive COVID-19 PCR analysis in pharyngeal swab or in tracheal secretion
  • Need oxygen supply to maintain SpO2 ≥ 92 %
  • Able to comply with continuous measurement of SpO2 by pulse oximetry.

You may not qualify if:

  • Need of oxygen supply \> 10 liters/min at admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hvidovre University Hospital

Copenhagen, 3550, Denmark

Location

MeSH Terms

Conditions

COVID-19Respiratory InsufficiencyHypoxia

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesRespiration DisordersSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ove Andersen, PhD

    Hvidovre University Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

September 24, 2020

First Posted

September 25, 2020

Study Start

April 15, 2020

Primary Completion

May 31, 2020

Study Completion

May 31, 2020

Last Updated

September 25, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)