NCT04393324

Brief Summary

Description of the adaptation of ICUs in the region of Madrid to que surge in demand of critical care due to 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
2,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2020

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

Study Start

First participant enrolled

April 24, 2020

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

May 17, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 19, 2020

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

May 28, 2020

Status Verified

May 1, 2020

Enrollment Period

1 month

First QC Date

May 17, 2020

Last Update Submit

May 26, 2020

Conditions

COVID-19ARDS, Human

Keywords

COVID-19ARDSRelocationICU capacity

Outcome Measures

Primary Outcomes (1)

  • Mortality

    ICU mortality

    9 weeks

Secondary Outcomes (1)

  • Length of ICU stay

    9 weeks

Study Arms (2)

Transferred patients

A subgroup of Critically ill intubated patients with COVID-19 associated ARDS were transferred from overwhelmed ICUs to other with available free beds

Matched Non-transferred patients

A subgroup from the global cohort, matched for risk factors will be compared with transferred patients for outcome variables

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Critically ill patients admitted to ICUs in Madrid for COVID-19

You may qualify if:

  • Admitted to ICU in Madrid with COVID-19

You may not qualify if:

  • Admitted to ICU without COVID-19

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinico San Carlos

Madrid, 28040, Spain

RECRUITING

MeSH Terms

Conditions

COVID-19Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Miguel Sánchez García, MD

    Hospital San Carlos, Madrid

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Miguel S Sanchez Garcia, MD

CONTACT

+34913303223miguelsanchez.hcsc@gmail.com

Antonio S Núñez Reiz

CONTACT

+34913303223anunezreiz@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
9 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Critical Care

Study Record Dates

First Submitted

May 17, 2020

First Posted

May 19, 2020

Study Start

April 24, 2020

Primary Completion

May 31, 2020

Study Completion

June 30, 2020

Last Updated

May 28, 2020

Record last verified: 2020-05

Locations

ES(1)