NCT04816786

Brief Summary

A retrospective analysis of the adult COVID-19 patients admitted to the ICU. A chart review will be conducted and multiple baseline characteristics, demographics, and treatments given will be recorded. Variables collected will include Age, Gender, BMI, Smoking status, Past medical history, Vital signs on admission, symptoms on admission, duration of symptoms, laboratory results on admission, treatment given. Treatment options will include (Steroids, plasma exchange, IVIG, antibiotics, mode of respiratory support). Primary outcomes will include; Death, duration of ICU stay, duration of mechanical ventilation, in-hospital complications. A regression model will be used to predict poor prognostic factors. Inclusion criteria: patients with confirmed PCR results for COVID-19 AND require ICU admission. Exclusion criteria: those with negative results, pediatric patients and those not requiring ICU admission.

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 Jan 2021

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

January 1, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 25, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

March 25, 2021

Status Verified

March 1, 2021

Enrollment Period

5 months

First QC Date

March 24, 2021

Last Update Submit

March 24, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • Death

    Death Vs No Death

    30 day mortality

  • Duration of ICU stay

    Duration of ICU stay

    30 days

  • Duration of mechanical ventilation

    The duration the patient required support from a mechanical ventilator

    30 days

Secondary Outcomes (1)

  • In-Hospital complications

    30 days

Study Arms (2)

Group 1: Admitted to ICU and died during the hospital stay.

Other: no intervention will be administered, this is a retrospective observational study.

Group 2: Admitted to ICU was were discharged.

Other: no intervention will be administered, this is a retrospective observational study.

Interventions

no intervention will be administered, this is a retrospective observational study.

Group 1: Admitted to ICU and died during the hospital stay.Group 2: Admitted to ICU was were discharged.

Eligibility Criteria

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

Patients presenting to the hospital and suspected of having the COVID-19 virus. Patients who are positive on a PCR test are usually traiged to be managed on the wards Vs ICU (Intensive care unit). This is based on a number of parameters; including but not limited to The severity of the symptoms, vital signs, lab results, co-morbidities, age.

You may qualify if:

  • Adults
  • Positive PCR test for COVID-19
  • Require admission to ICU

You may not qualify if:

  • Pediatric patients\\
  • Any patient not requiring admission to ICU

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mubarak al Kabeer hospital

Kuwait City, Outside U.S./Canada, 00000, Kuwait

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Waleed burhamah, General surgery resident MKH MB BCH BOA

Study Record Dates

First Submitted

March 24, 2021

First Posted

March 25, 2021

Study Start

January 1, 2021

Primary Completion

June 1, 2021

Study Completion

July 1, 2021

Last Updated

March 25, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations