NCT04342104

Brief Summary

Evaluate HACOR socre utility and efficacy in predicting NIV and/or CPAP failure in patients with COVID-19 associated respiratory failure. Propose adaptations to HACOR score based on the "state of art" 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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2020

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

Study Start

First participant enrolled

April 1, 2020

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

April 8, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 10, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2021

Completed
Last Updated

August 30, 2021

Status Verified

August 1, 2021

Enrollment Period

8 months

First QC Date

April 8, 2020

Last Update Submit

August 26, 2021

Conditions

Keywords

noninvasive ventilationCPAPCovid-19Respiratory failureHACOR score

Outcome Measures

Primary Outcomes (2)

  • HACOR score efficacy

    Analyze if HACOR score is effective in predicting nonivasive ventilation failure in COVID-19 associated respiratory failure

    1 hour after initation of CPAP or NIV

  • HACOR score addaptation

    Analyze the role of possible variables to be added to HACOR score in order to improve efficay in COVID-19 patients

    1 - 2 weeks

Study Arms (2)

NIV

Patients on Bilevel NIV

Other: Monitoring for aggravationOther: Evaluate HACOR score effectivity in this patients

CPAP

Patients on CPAP

Other: Monitoring for aggravationOther: Evaluate HACOR score effectivity in this patients

Interventions

Monitor patients on CPAP or NIV and analyzing possible variables that may predict failure, namely: * lymphopenia * thrombocytopenia * CRP * ferritin * LDH * troponin I * NT-ProBNP * Liver enzymes * D-dimers * radiologic aggravation " 1 day and 1 week after starting NIV or CPAP

CPAPNIV

Apply the HACOR score after starting NIV and CPAP and later verify if it was effective in predicting NIV/CPAP failure

CPAPNIV

Eligibility Criteria

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

Patients with acute respiratory failure due to COVID-19 who have initiated NIV or CPAP based on assistant clinician decision

You may qualify if:

  • Patients with acute respiratory failure due to COVID-19 who have initiated NIV or CPAP based on assistant clinician decision

You may not qualify if:

  • Patients with imediate indication to invasive mechanical ventilation
  • Patients with any formal contraindication to noninvasive respiratory support

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital General Universitario Morales Meseguer

Murcia, Spain

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample for biochemistry and blood count

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

  • Miguel Guia

    Hospital General Universitario Morales Meseguer

    PRINCIPAL INVESTIGATOR
  • Antonio Esquinas

    Hospital General Universitario Morales Meseguer

    STUDY DIRECTOR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

April 8, 2020

First Posted

April 10, 2020

Study Start

April 1, 2020

Primary Completion

November 30, 2020

Study Completion

November 15, 2021

Last Updated

August 30, 2021

Record last verified: 2021-08

Locations