NCT05089110

Brief Summary

The aim of the study is to assess the expression of TLR 3, 7, and 9 in the population of peripheral blood mononuclear cells (PBMC) and in B lymphocytes (CD19+), T lymphocytes (CD4+ and CD8+) using flow cytometry in relation to the clinical parameters and outcome of COVID 19 patients .

Trial Health

35
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 Nov 2021

Typical duration for all trials

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

October 21, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 22, 2021

Completed
10 days until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

October 26, 2021

Status Verified

October 1, 2021

Enrollment Period

3 years

First QC Date

October 21, 2021

Last Update Submit

October 21, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Cytokines storm occurrence in COVID-19 patients

    To assess whether the expression of toll-like receptors 3,7 and 9 in peripheral blood mononuclear cells related to the clinical status of COVID-19 patients and probability of cytokines storm occurrence

    Baseline

Interventions

blood samplePROCEDURE

5 cm blood sample from COVID-19 patients

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed as confirmed COVID-19 when they have a positive result of RT-PCR for SARS-CoV-2 RNA or confirmed diagnosis by typical clinical picture and radiological methods , according to the WHO and Egyptian Ministry of Health and Population (MOH) definitions, at Assiut University Hospital

You may qualify if:

  • Patients ≥18 years old of both genders.
  • Patients diagnosed as confirmed COVID-19 when they have a positive result of RT-PCR for SARS-CoV-2 RNA or confirmed diagnosis by typical clinical picture and radiological methods , according to the WHO and Egyptian Ministry of Health and Population (MOH) definitions, at Assiut University Hospital.

You may not qualify if:

  • Children less than 18 years.
  • Patients refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Matthay MA, Zemans RL, Zimmerman GA, Arabi YM, Beitler JR, Mercat A, Herridge M, Randolph AG, Calfee CS. Acute respiratory distress syndrome. Nat Rev Dis Primers. 2019 Mar 14;5(1):18. doi: 10.1038/s41572-019-0069-0.

    PMID: 30872586BACKGROUND
  • Mehta P, McAuley DF, Brown M, Sanchez E, Tattersall RS, Manson JJ; HLH Across Speciality Collaboration, UK. COVID-19: consider cytokine storm syndromes and immunosuppression. Lancet. 2020 Mar 28;395(10229):1033-1034. doi: 10.1016/S0140-6736(20)30628-0. Epub 2020 Mar 16. No abstract available.

    PMID: 32192578BACKGROUND

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Gamal Agamy, professor

    Assiut University

    STUDY CHAIR
  • Mohammad Adam, professor

    Assiut University

    STUDY CHAIR

Central Study Contacts

Fady Markos, resident doctor

CONTACT

Manal AL Khawaga, lecturer

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor

Study Record Dates

First Submitted

October 21, 2021

First Posted

October 22, 2021

Study Start

November 1, 2021

Primary Completion

November 1, 2024

Study Completion

November 1, 2024

Last Updated

October 26, 2021

Record last verified: 2021-10