Back to resultsRole of Interleukin-6 and Procalcitonin as Novel Inflammatory Biomarkers in Evaluating COVID 19 Disease Severity - an Experience at CMH Quetta
Primary Purpose
Covid19 Positive Patients
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Interlukein 6 and procalcitonin serum levels
Sponsored by
About this trial
This is an interventional diagnostic trial for Covid19 Positive Patients
Eligibility Criteria
Inclusion Criteria:
- positive PCR of COVID 19
Exclusion Criteria:
- NEGATIVE PCR of COVID 19
Sites / Locations
- Cmh Quetta
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Interlukein 6 and procalcitonin
Arm Description
Interlukein 6 and procalcitonin levels in COVID 19 patients
Outcomes
Primary Outcome Measures
Levels of inflammatory biomarkers is raised in accordance with severity of COVID 19
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04945811
Brief Title
Role of Interleukin-6 and Procalcitonin as Novel Inflammatory Biomarkers in Evaluating COVID 19 Disease Severity - an Experience at CMH Quetta
Official Title
Role of Interleukin-6 and Procalcitonin in Evaluating COVID 19 Disease Severity - an Experience at CMH Quetta
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
May 15, 2021 (Actual)
Study Completion Date
May 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
FARAH AFZAL
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19 Positive Patients
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interlukein 6 and procalcitonin
Arm Type
Experimental
Arm Description
Interlukein 6 and procalcitonin levels in COVID 19 patients
Intervention Type
Diagnostic Test
Intervention Name(s)
Interlukein 6 and procalcitonin serum levels
Intervention Description
Blood tests
Primary Outcome Measure Information:
Title
Levels of inflammatory biomarkers is raised in accordance with severity of COVID 19
Description
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.
Time Frame
2 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
38 Years
Maximum Age & Unit of Time
71 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
positive PCR of COVID 19
Exclusion Criteria:
NEGATIVE PCR of COVID 19
Facility Information:
Facility Name
Cmh Quetta
City
Quetta
State/Province
Balochistan
ZIP/Postal Code
1234
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Role of Interleukin-6 and Procalcitonin as Novel Inflammatory Biomarkers in Evaluating COVID 19 Disease Severity - an Experience at CMH Quetta
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