Role of Interleukin-6 and Procalcitonin as Novel Inflammatory Biomarkers in Evaluating COVID 19 Disease Severity - an Experience at CMH Quetta

June 29, 2021 updated by: FARAH AFZAL

Role of Interleukin-6 and Procalcitonin in Evaluating COVID 19 Disease Severity - an Experience at CMH Quetta

Serum Interleukin-6 and Procalcitonin of 100 consenting COVID 19 positive patients from April 2020 - May 2021 were assessed at Pathology department CMH Quetta and the results were correlated with severity of lung involvement on HRCT Chest

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Objective: To explore the relation between Interleukin-6 and Procalcitonin with COVID severity on HRCT Chest Study Design: Randomized Control Trial (Clinical Trials. gov Identifier: NCT04798391) Place and duration of study: Pathology, Radiology & ENT Department CMH Quetta from April 2020 - May 2021 Methodology: Serum Interleukin-6 and Procalcitonin of 100 consenting COVID 19 positive patients from April 2020 - May 2021 were assessed at Pathology department CMH Quetta and the results were correlated with severity of lung involvement on HRCT Chest Results: Serum Interlukin-6 levels were raised in 97 (97%) patients with mean levels of 20.43 + 19.66 (pg/ml). Serum procalcitonin levels were raised in 95 (95%) patients with mean levels of 0.4331 + 0.24 (ng/ml). A P value of <0.001 was calculated on Independent Sample T-test for both serum interlukin-6 and serum procalcitonin as correlated with severity of lung involvement on HRCT Chest.

Conclusion: Interlukin-6 and procalcitonin are excellent biomarkers for diagnosis and predicting severity of COVID19 pneumonia.

Keywords: Covid19 pneumonia, Interlukin-6, procalcitonin.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Balochistan
      • Quetta, Balochistan, Pakistan, 1234
        • Cmh Quetta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • positive PCR of COVID 19

Exclusion Criteria:

  • NEGATIVE PCR of COVID 19

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interlukein 6 and procalcitonin
Interlukein 6 and procalcitonin levels in COVID 19 patients
Diagnostic test: Interlukein 6 and procalcitonin serum levels
Blood tests

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Levels of inflammatory biomarkers is raised in accordance with severity of COVID 19
Time Frame: 2 days

serum Interlukin-6 levels was measured on COBAS-e 411 Immunoassay analyzer using electro chemiluminescence methodology using Roche Interlukin-6 kit with raised levels taken as > 7 pico gram / milliliter (pg/ml). Serum procalcitonin were also measured by similar methodology using Roche procalcitonin kit with raised levels taken as > 0.15 nano gram / milliliter (ng/ml).

COVID 19 pneumonia was categorized on HRCT chest as Mild with total score 7 or less, moderate with score from 8 - 17, and severe with score more than 18.
2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

FARAH AFZAL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2020

Primary Completion (Actual)

May 15, 2021

Study Completion (Actual)

May 30, 2021

Study Registration Dates

First Submitted

June 29, 2021

First Submitted That Met QC Criteria

June 29, 2021

First Posted (Actual)

June 30, 2021

Study Record Updates

Last Update Posted (Actual)

June 30, 2021

Last Update Submitted That Met QC Criteria

June 29, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMHQ3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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