NCT05682612

Brief Summary

Five percent of patients with COVID-19 progressed to respiratory failure and required ICU admission, such patients often have abnormal oxygen tolerance. However, there is still a lack of clinical indicators to predict the prognosis and treatment responsiveness of COVID-19.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

January 1, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

January 9, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 12, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

October 12, 2023

Status Verified

October 1, 2023

Enrollment Period

11 months

First QC Date

January 1, 2023

Last Update Submit

October 9, 2023

Conditions

Keywords

ARDSrespiratory failureCOVID-19

Outcome Measures

Primary Outcomes (1)

  • Level of Transcutaneous partial pressure of oxygen

    Level of Transcutaneous partial pressure of oxygen

    up to 30 days

Secondary Outcomes (1)

  • Level of Transcutaneous partial pressure of oxygen/FiO2

    up to 30 days

Study Arms (2)

Survivors

Survivors of COVID-19 induced respiratory failure

Other: outcomeOther: Subtype of COVID-19

Nonsurvivors

Nonsurvivors of COVID-19 induced respiratory failure

Other: outcomeOther: Subtype of COVID-19

Interventions

outcomeOTHER

hospital survivors and nonsurvivors

NonsurvivorsSurvivors

Different subtype of COVID-19

NonsurvivorsSurvivors

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

COVID-19 patients

You may qualify if:

  • Age: 18-80 years, male or female; Patients with COVID-9 pneumonia (typical imaging features of COVID-19 pneumonia) (oxygen saturation ≤ 93% during air or arterial partial pressure of oxygen (PaO2)/oxygen concentration (FiO2) ≤ 300 mmHg at rest);

You may not qualify if:

  • Pregnant or lactating women; Patients who refuse to undergo transcutaneous tissue oxygen pressure monitoring; Clinicians believe that patients are not appropriate; Patients undergoing ECMO.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongda hospital

Nanjing, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Conditions

Respiratory InsufficiencyCOVID-19

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung Diseases

Study Officials

  • Jingyuan Xu, M.D.

    Southeast University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jingyuan Xu, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 1, 2023

First Posted

January 12, 2023

Study Start

January 9, 2023

Primary Completion

December 1, 2023

Study Completion

December 30, 2023

Last Updated

October 12, 2023

Record last verified: 2023-10

Locations