| CTRI Number |
CTRI/2020/08/027110 [Registered on: 13/08/2020] Trial Registered Prospectively |
| Last Modified On: |
13/08/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
The role of markers(nlr,il-6,d-dimer) in COVID-19 patients and it’s co-relationship with oxygenation ,a retrospective observational study in Tertiary care covid ICU |
|
Scientific Title of Study
|
The predictive role of markers in COVID-19 patients and it’s co-relationship with spo2/fio2and pao2/fio2 ratio,a retrospective observational study in Tertiary care covid ICU |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arin Choudhury |
| Designation |
Assistant Professor |
| Affiliation |
Vmmc and Safdarjung Hospital |
| Address |
Department of Anaesthesia
Vmmc and Safdarjung Hospital
Ansari Nagar
Vmmc and Safdarjung Hospital
Ansari Nagar
South
DELHI
110029
India |
| Phone |
7838756566 |
| Fax |
|
| Email |
arinchoudhury@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Arin Choudhury |
| Designation |
Assistant Professor |
| Affiliation |
Vmmc and Safdarjung Hospital |
| Address |
Department of Anaesthesia
Vmmc and Safdarjung Hospital
Ansari Nagar
Vmmc and Safdarjung Hospital
Ansari Nagar
DELHI
110029
India |
| Phone |
7838756566 |
| Fax |
|
| Email |
arinchoudhury@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Arin Choudhury |
| Designation |
Assistant Professor |
| Affiliation |
Vmmc and Safdarjung Hospital |
| Address |
Department of Anaesthesia
Vmmc and Safdarjung Hospital
Ansari Nagar
Vmmc and Safdarjung Hospital
Ansari Nagar
DELHI
110029
India |
| Phone |
7838756566 |
| Fax |
|
| Email |
arinchoudhury@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vmmc and Safdarjung Hospital,
ansari nagar,Newdelhi 110029 |
|
|
Primary Sponsor
|
| Name |
Vmmc and Safdarjung Hospital |
| Address |
Ansari Nagar
Delhi |
| Type of Sponsor |
Government medical college |
|
|
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 |
| arin choudhury |
Vmmc and Safdarjung Hospital |
Room no 221,covid icu zone 1 ,Pvt block SSB,ansari Nagar
South
DELHI |
7838756566
arinchoudhury@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| vmmc and safdarjung ethical committee |
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: J09X||Influenza due to identified novelinfluenza A virus, (3) ICD-10 Condition: J111||Influenza due to unidentified influenza virus with other respiratory manifestations, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
all covid Patient |
|
| ExclusionCriteria |
| Details |
non covid Patient Excluded |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To identify the level of markers determining outcome of COVID 19 patient |
baseline,at 1day,3day,6 day ,7 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To find the correlation between SpO2/FiO2 and markers for progression of severity of COVID
To find the co-relationship between PaO2/FiO2 and markers for progression of severity of COVID. |
on icu admission,aafter 3 days ,6days,9 days |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
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)
|
22/08/2020 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Although it is a known fact that inflammation is caused by infectious diseases, and growing evidence supports its significant role in the progression of various viral pneumonia, including COVID-19 [7]. Severe inflammatory responses contribute to weak adaptive immune response, thereby resulting in immune response imbalance. Therefore, circulating biomarkers that represent inflammation and immune status are known potential predictors for the prognosis of COVID-19 patients [8]. Peripheral white blood cell (WBC) count, neutrophil (NEU)-to-lymphocyte (LYM) ratio (NLR), derived NLR ratio (d-NLR, neutrophil count divided by the result of WBC count minus neutrophil count), platelet-to-lymphocyte ratio (PLR) and lymphocyte-to-monocyte ratio (LMR),interleukin 6 are indicators of the systemic inflammatory response [9] that are widely investigated as useful predictors for the prognosis of patients with viral pneumonia. By collecting the data from confirmed cases, we will attempt to determine the effect of sex, age, CRP, WBC count, NLR, LMR, PLR, and co morbidities on the prognosis of patients with COVID-19 pneumonia and it’s corelation with lungs oxygenation. |