| CTRI Number |
CTRI/2020/10/028523 [Registered on: 21/10/2020] Trial Registered Prospectively |
| Last Modified On: |
20/10/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Hematological and biochemical abnormalities parameters in the severity of COVID-19 |
|
Scientific Title of Study
|
The abnormalities in hematological and biochemical parameters and correlation evaluation between laboratory examinations and the severity of COVID-19. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hitesh Shah |
| Designation |
Professor, HOD |
| Affiliation |
Pramukhswami Medical College, Karamsad |
| Address |
Biochemistry Department,Pramukhswami Medical College, Karamsad 388325
Anand
GUJARAT
388325
India |
| Phone |
9825357205 |
| Fax |
|
| Email |
hiteshns@charutarhealth.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hitesh Shah |
| Designation |
Professor, HOD |
| Affiliation |
Pramukhswami Medical College, Karamsad |
| Address |
Biochemistry Department,Pramukhswami Medical College, Karamsad 388325
Anand
GUJARAT
388325
India |
| Phone |
9825357205 |
| Fax |
|
| Email |
hiteshns@charutarhealth.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abdulrahman Amer |
| Designation |
Consultant |
| Affiliation |
Pramukhswami Medical College, Karamsad |
| Address |
Biochemistry Department,Pramukhswami Medical College, Karamsad 388325
Anand
GUJARAT
388325
India |
| Phone |
9825357205 |
| Fax |
|
| Email |
hefdhallaha@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Parumkhswami Medicall College and Shree Krishna Hospital |
| Address |
Anand - Sojitra Rd, Gokul Nagar, Karamsad, Anand, Gujarat 388325 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Hitesh Shah |
PSMC, Karmsad |
Head Office of Biochemistry Department, Pramukhswami Medical College, Karamsad, Anand, Gujarat 388325
Anand
GUJARAT |
9825357205
hiteshns@charutarhealth.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, HM PATEL CENTER FOR MEDICAL CARE AND EDUCATION, KARAMSAD |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, (2) ICD-10 Condition: B998||Other infectious disease, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients with positive RT-PCR for COVID-19 |
|
| ExclusionCriteria |
| Details |
Patients with positive serology without conformed by RT-PCR for COVID-19. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To investigate the ability of C-reactive protein (CRP), ferritin, interleukin-6 (IL-6), and procalcitonin (PCT) to predict mild and severe cases of COVID-19. |
Three month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the accuracy of others laboratory parameters (CBC, Differential Count, Thrombin Time, D DIMER and Lactate Dehydrogenase) in predicting cases with positive RT-PCR for COVID-19. |
Three Month |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/10/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Coronavirus disease (COVID-19) is an infectious disease caused by a new virus. The disease causes respiratory illness (like the flu) with signs and symptoms such as a cough, fever, and in more severe cases, difficulty breathing. To address this outbreak, it is requiring to provide a solution including diagnostics, medical devices, Sanitizers, Disinfectants, masks, ventilators, goggles, and other medical equipment. The global coronavirus disease 2019 (COVID-19) has presented major challenges for clinical laboratories, from the initial diagnosis to patient monitoring and treatment. In addition to the relationship between results of hematological and biochemical tests and the severity of Covid 19 disease that will be helpful for physicians to determine the appropriate treatment. As tocilizumab is a humanized monoclonal antibody against interleukin-6. In addition to the early indications and clinical benefit of tocilizumab in severe COVID-19 disease, clinical studies are needed to clarify the elevation of IL-6 in the severe COVID-19. The current study was designed to study the abnormalities of the hematological and biochemical tests in COVID-19 patients. 1.1 Objectives of the present study Ø To investigate the ability of C-reactive protein (CRP), ferritin, interleukin-6 (IL-6), and procalcitonin (PCT) to predict mild and severe cases of COVID-19. Ø To evaluate the accuracy of others laboratory parameters (CBC, Differential Count, Thrombin Time, D DIMER and Lactate Dehydrogenase) in predicting cases with positive RT-PCR for COVID-19. Ø To assess the role of tocilizumab in reducing risk in patients with severe pneumonia COVID-19 and its association with interleukin-6. 2- Material and method: The Shree Krishna Hospital was designated to treat COVID-19 patients in Anand – Gujarat. The study will be carried out at biochemistry department of the central diagnostic laboratory of the Shree Krishna Hospital attached to Pramukhswami Medical College, Karamsad. We will include all cases of COVID-19 were admitted in this hospital between August, 2020, and September, 2020. - Study design: Retrospective study - Inclusion & exclusion criteria, sampling procedures etc. Inclusion: - Patients with positive RT-PCR for COVID-19. Exclusion: - Patients with positive serology without conformed by RT-PCR for COVID-19. |