NCT05477394

Brief Summary

SARS-COV-2 crisis is a severe public health concern in the world. It is now well recognized that older age, diabetes mellitus, obesity (BMI \> 30 kg/m2), and hypertension increase the risk of complications and death in SARS-COV-2 patients. This study will describe the spectrum of clinical features, the likely pathophysiologic mechanisms, and potential implications for the management of metabolic syndrome in SARS-COV-2 patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 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

April 1, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 15, 2022

Completed
5 months until next milestone

First Posted

Study publicly available on registry

July 28, 2022

Completed
Last Updated

July 28, 2022

Status Verified

July 1, 2022

Enrollment Period

9 months

First QC Date

March 15, 2022

Last Update Submit

July 25, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • The period of time that Covid patients spent in intensive care and its outcome.

    We note whether metabolic syndrome in cases of Covid is related to the length of stay in the hospital or not.

    6 months

Secondary Outcomes (1)

  • number of Covid patients who needed mechanical ventilation.

    6 months

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

• critical SARS-COV-2 patients. * patients admitted to for Sever Pneumonic COVID-19 infection with a confirmed positive RT-PCR for COVID-19 and chest computed tomography that is divided into two groups. * Group one is critical COVID patients with metabolic syndrome . * Group two is critical COVID witout metabolic syndrome . Sample Size: 45 patients for each group

You may qualify if:

  • patients admitted to for Sever Pneumonic COVID-19 infection with a confirmed positive RT-PCR for COVID-19 and chest computed tomography that is divided into two groups.
  • Group one is critical COVID patients with metabolic syndrome .
  • Group two is critical COVID without metabolic syndrome .
  • Age 21-50 years old.
  • Sex both sexes.
  • Patients having metabolic syndrome defined before who have:
  • Diabetes mellitus.
  • Hypertension.
  • Obesity( BMI \< 30 kg/m2)

You may not qualify if:

  • \. Patients below 21 years old. 2. Psychiatric disorders. 3. Lack of consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Officials

  • amr mo hilal

    Ain Shams University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2022

First Posted

July 28, 2022

Study Start

April 1, 2021

Primary Completion

December 30, 2021

Study Completion

January 30, 2022

Last Updated

July 28, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will share

we will share data which prove that covid patient with metabolic syndrome has a bad prognosis during his treatment

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
6 months
Access Criteria
send to DR.heba992@gmail.com
More information

Locations