NCT04979195

Brief Summary

In Kuwait, the total number of COVID-19 confirmed cases exceeds 5000 patients. Risk factors of possible risk factors of confirmed COVID-19 infection that developed major organ dysfunction are not yet identified among patients in Kuwait. we aimed to describe the clinical characteristics of hospitalized symptomatic COVID-19 positive patients, assess possible risk factors of confirmed COVID-19 infection who developed major organ dysfunction, determine risk factors for renal dysfunction and their outcome and assess the response of critically ill patients to different therapeutic modalities.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
649

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 28, 2021

Completed
Last Updated

July 28, 2021

Status Verified

March 1, 2020

Enrollment Period

6 months

First QC Date

July 22, 2021

Last Update Submit

July 26, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • patient survival

    Patients who survived after 30 days.

    30 days

  • Kidney survival

    Patients who have stable basal kidney function.

    30 days

Study Arms (2)

Group 1

patients with stable renal function.

Other: Patients with stable normal kidney functionOther: Patients with unstable kidney function

Group 2

Patients who developed AKI.

Other: Patients with stable normal kidney functionOther: Patients with unstable kidney function

Interventions

Covid-19 patients with stable kidney function will represent group 1.

Also known as: Covid-19 patients with stable kidney fucntion.
Group 1Group 2

Covid-19 patients with unstable kidney function will represent group 2.

Also known as: Covid-19 patients with unstable kidney fucntion.
Group 1Group 2

Eligibility Criteria

Age21 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

649 COVID-19 positive patients were identified. Sixty-three were isolated at home and 586 cases needed hospital admission during the period between the 1st week of March till the end of August 2020. Among the hospitalized cases, 258 needed ICU care while 328 were managed in the COVID general wards. We compared patients with stable renal function (group 1, n=319) vs. those who developed AKI (group 2, n=267). We collected the data from COVID-19 positive patients that were diagnosed in all government hospitals in Kuwait. Clinical features, details of management, and both patient and renal outcomes were recorded. We compiled patients' data from the electronic database of the isolation hospitals where COVID -19 cases were managed. Approval for the study was obtained from the ethical committee of the Kuwait Ministry of Health.

You may qualify if:

  • All adult patients were included.
  • Hospitalized with PCR confirmed COVID-19 infection.
  • period between March to August 2020.

You may not qualify if:

  • Pediatric patients Home isolated patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Osama Gheith

Kuwait City, AZ, 23424, Kuwait

Location

Osama Gheith

Kuwait City, Rf, Kuwait, Kuwait

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2021

First Posted

July 28, 2021

Study Start

March 1, 2020

Primary Completion

August 31, 2020

Study Completion

August 31, 2020

Last Updated

July 28, 2021

Record last verified: 2020-03

Locations