- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04945811
Role of Interleukin-6 and Procalcitonin as Novel Inflammatory Biomarkers in Evaluating COVID 19 Disease Severity - an Experience at CMH Quetta
Role of Interleukin-6 and Procalcitonin in Evaluating COVID 19 Disease Severity - an Experience at CMH Quetta
Study Overview
Status
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Balochistan
-
Quetta, Balochistan, Pakistan, 1234
- Cmh Quetta
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- positive PCR of COVID 19
Exclusion Criteria:
- NEGATIVE PCR of COVID 19
Study Plan
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
|
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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