NCT05157152

Brief Summary

In critically ill patients, AKI is a common complication of COVID-19 infection, occurring in 23% to 43% of cases, and was correlated with poor clinical outcomes. An increase in liver function tests ( LFTs) has been found in patients with COVID-19 ranging 14%-75% Some studies found higher levels of transaminases in patients with severe COVID-19 pneumonia and in patients dying for COVID-19. Initial reports indicate a high incidence of abnormal liver tests and acute kidney injury (AKI) in the novel coronavirus infection (COVID-19). We hypothesis that there is a relationship between COVID-19 patients who are critically ill, liver enzymes and level of serum creatinine

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
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2022

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

First Submitted

Initial submission to the registry

December 12, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 14, 2021

Completed
18 days until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2022

Completed
Last Updated

December 14, 2021

Status Verified

December 1, 2021

Enrollment Period

4 months

First QC Date

December 12, 2021

Last Update Submit

December 12, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Relationship between liver enzymes and AKI in patients with COVID19

    Elevated Liver Enzymes as a predictor of Acute Kidney Injury in hospitalized patients with COVID-19

    4 months

Secondary Outcomes (1)

  • Severity of COVID19 infection

    4 months

Eligibility Criteria

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

Patients with respirator symptoms of COVID-19 admitted at Sohag university hospital

You may qualify if:

  • Patients who are positive for COVID-19 infection in Sohag University Hospital whose ages \< 18 years old. (confirmed by polymerase chain reaction (PCR) from nasopharyngeal or oropharyngeal samples) who developed AKI at time of admission or during admission.

You may not qualify if:

  • Patients whose ages \>18 years old.
  • Patients known to have any liver disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SOHAGU

Sohag, 28511, Egypt

RECRUITING

Related Publications (1)

  • Ngiam JN, Chew N, Tham SM, Lim ZY, Li TY, Cen S, Tambyah PA, Santosa A, Muthiah M, Sia CH, Cross GB. Elevated liver enzymes in hospitalized patients with COVID-19 in Singapore. Medicine (Baltimore). 2021 Jul 30;100(30):e26719. doi: 10.1097/MD.0000000000026719.

    PMID: 34397705BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Liver enzymes, serum creatinine, CBC, PCR

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Officials

  • Ahmed Ka Osman, Resident

    Sohag university-faculty of medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Ka Osman, Resident

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor at internal medicine department, sohag university hospital

Study Record Dates

First Submitted

December 12, 2021

First Posted

December 14, 2021

Study Start

January 1, 2022

Primary Completion

April 30, 2022

Study Completion

May 30, 2022

Last Updated

December 14, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will share

Study protocol Methods Consent form

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
April 2022 forever
Access Criteria
Any One have access

Locations