NCT05367882

Brief Summary

  1. 1.Investigate the possible effects of interleukin-6 receptor antagonists such as tocilizumab and sarilumab on the levels of IL-6, inflammtory and anti-inflammtory markers and cytokines before and after treatment in critically ill corona virus disease-19 patients.
  2. 2.Correlate between IL-6 levels with other inflammatory markers as ferritin and C-reactive protein.
  3. 3.investigate the possible changes on the levels of other inflammatory, anti-inflammatory markers and cytokines such as IL-10 and IP-10, before and after treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2022

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

February 1, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 10, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2023

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 24, 2023

Completed
Last Updated

July 25, 2023

Status Verified

April 1, 2022

Enrollment Period

1.5 years

First QC Date

April 22, 2022

Last Update Submit

July 24, 2023

Conditions

Corona Virus Infection

Keywords

interleukin-6 receptor antagonistsCorona virus diseasesarilumabinterferon gamma inducible protein-10

Outcome Measures

Primary Outcomes (5)

  • interleukin-6 levels

    Measuring the levels of interleukin-6 in serum of patients.

    during one year

  • interleukin-10 levels

    measuring the levels of interleukin-10 in serum of patients before and after treatment

    during one year

  • inflammatory markers

    measuring the levels of some inflammatory markers in serum patients

    during one year

  • interferon gamma inducible protein-10 levels

    measuring the levels of IP-10 in serum of patients before and after treatment

    during one year

  • anti-inflammatory markers

    measuring the levels of some anti-inflammatory markers in serum of patients before and after treatment

    during one year

Secondary Outcomes (1)

  • survival

    during one year

Other Outcomes (1)

  • Incidence of ventilatory support

    during one year

Study Arms (1)

critically ill COVID-19 patients in ICU

critically ill COVID-19 patients who are recommended to receive IL-6R antagonist as tocilizumab at the dosage of 8 mg/kg with a second dose 12 hours after the first dosage, or sarilumab at the dosage of 200 mg subcutaneously or 200 to 800 mg intravenously.

Diagnostic Test: ELISA

Interventions

ELISADIAGNOSTIC_TEST

collection of blood samples from critically ill COVID-19 patients, then serum samples are collected after centrifugation measuring IL-6, IL-10 and IP-10 by ELISA

critically ill COVID-19 patients in ICU

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

samples will be collected over a duration of one year

You may qualify if:

  • must be critically ill coronavirus disease-19

You may not qualify if:

  • patients receiving corticosteroids
  • pregnancy
  • active TB
  • bacterial infection
  • fungal infection
  • co-infection with other hepatitis viruses.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AssiutU

Asyut, 71515, Egypt

Location

Related Publications (1)

  • Li Q, Guan X, Wu P, Wang X, Zhou L, Tong Y, Ren R, Leung KSM, Lau EHY, Wong JY, Xing X, Xiang N, Wu Y, Li C, Chen Q, Li D, Liu T, Zhao J, Liu M, Tu W, Chen C, Jin L, Yang R, Wang Q, Zhou S, Wang R, Liu H, Luo Y, Liu Y, Shao G, Li H, Tao Z, Yang Y, Deng Z, Liu B, Ma Z, Zhang Y, Shi G, Lam TTY, Wu JT, Gao GF, Cowling BJ, Yang B, Leung GM, Feng Z. Early Transmission Dynamics in Wuhan, China, of Novel Coronavirus-Infected Pneumonia. N Engl J Med. 2020 Mar 26;382(13):1199-1207. doi: 10.1056/NEJMoa2001316. Epub 2020 Jan 29.

    PMID: 31995857BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum samples of Corona virus disease-19 patients

MeSH Terms

Conditions

Coronavirus Infections

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • mohammad gamal abalrahman, lecturer

    Assiut university, Egypt

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 22, 2022

First Posted

May 10, 2022

Study Start

February 1, 2022

Primary Completion

July 20, 2023

Study Completion

July 24, 2023

Last Updated

July 25, 2023

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)