NCT05274503

Brief Summary

Serum IL-6 levels will be determined by enzyme-linked immunosorbent assay according to the manufacturer's instructions and the normal range is \<10 pg/mL , Patients' medical records will be carefully reviewed and analyzed. Patient data regarding demographics, comorbidities, signs and symptoms, laboratory results and complications will be collected. The occurrence of complications will be confirmed according to the following criteria: acute respiratory distress syndrome (ARDS) defined according to the Berlin definition

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2021

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

June 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 10, 2022

Completed
Last Updated

March 10, 2022

Status Verified

February 1, 2022

Enrollment Period

6 months

First QC Date

March 9, 2022

Last Update Submit

March 9, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • detection of acute respiratory distress syndrome

    hypoxia, incresed plateau pressure

    2 weeks

Eligibility Criteria

Age20 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients more than 20 years old, covid positive, mechanically ventilated

You may qualify if:

  • Age: more than 20 years.
  • Gender: both males and females will be included.
  • Mechanically Ventilated patients.
  • COVID 19 confirmed diagnosis

You may not qualify if:

  • Immunocompromised patients.
  • Oxygen saturation more than 95% without ventilation.
  • Malignancy.
  • Patients refuse to be enrolled in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University, Faculty of Medicine

Sohag, Egypt

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of anesthesia and intensive care

Study Record Dates

First Submitted

March 9, 2022

First Posted

March 10, 2022

Study Start

June 1, 2021

Primary Completion

December 1, 2021

Study Completion

January 1, 2022

Last Updated

March 10, 2022

Record last verified: 2022-02

Locations