| CTRI Number |
CTRI/2021/06/034303 [Registered on: 18/06/2021] Trial Registered Prospectively |
| Last Modified On: |
18/06/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective study |
| Study Design |
Other |
|
Public Title of Study
|
Alternations of blood parameters corona positive patients. |
|
Scientific Title of Study
|
Variations in the biochemical parameters of Covid-19 patients admitted in a tertiary care hospital of Dakshina Kannada : A retrospective study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mahalaxmi S Petimani |
| Designation |
Assistant Professor of Biochemistry |
| Affiliation |
Yenepoya Medical College |
| Address |
Yenepoya Medical College
Deralakatte
Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
09036560538 |
| Fax |
|
| Email |
mahalaxmi.petimani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahalaxmi S Petimani |
| Designation |
Assistant Professor of Biochemistry |
| Affiliation |
Yenepoya Medical College |
| Address |
Yenepoya Medical College
Deralakatte
Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
09036560538 |
| Fax |
|
| Email |
mahalaxmi.petimani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahalaxmi S Petimani |
| Designation |
Assistant Professor of Biochemistry |
| Affiliation |
Yenepoya Medical College |
| Address |
Yenepoya Medical College
Deralakatte
Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
09036560538 |
| Fax |
|
| Email |
mahalaxmi.petimani@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yenepoya Medical College, Deralakatte, Mangalore |
|
|
Primary Sponsor
|
| Name |
Dr Mahalaxmi S Petimani |
| Address |
Yenepoya Medical College
Deralakatte
Mangalore |
| Type of Sponsor |
Other [Self funded study] |
|
|
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 Mahalaxmi S Petimani |
Yenepoya Medical College Hospital |
Department of Biochemistry, Yenepoya Medical College, Deralakatte
Dakshina Kannada
KARNATAKA |
09036560538
mahalaxmi.petimani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya Ethics Committee 1 |
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: B338||Other specified viral diseases, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Covid-19 patients who are admitted in YMCH during 22nd June 2020 to 22nd September 2020 of any age and gender having all the required details like laboratory parameters in their case file and central laboratory data base. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Variations in biochemical parameters in mild, moderate and severe covid patients |
base line & 3 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="147"
Sample Size from India="147"
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)
|
20/06/2021 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Study is not yet started. So not published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This retrospective study includes details of
Covid-19 patients who were admitted in Yenepoya Medical College Hospital, Mangalore, during 22nd June 2020 to
22nd September 2020. Various biochemical parameters like, RT-PCR
result, CBC, LFT, RFT, LDH, Trop I, CK-MB D-dimer, CRP and ferritin levels,
RBS/FBS/PPBS (Initial two reports of the patient of 72 hours gap) and patient
co-morbidity details like Asthma, COPD, Hypertension OR any other chronic
diseases will be recorded from Central Laboratory and & Medical Record
Department of Yenepoya Medical College Hospital Deralakatte, Mangalore. The data will be entered in the data sheet.
Patient name is anonymized. |