| CTRI Number |
CTRI/2020/12/029744 [Registered on: 11/12/2020] Trial Registered Prospectively |
| Last Modified On: |
10/12/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Analysing impact of pre-existing comorbidities on serious adverse outcomes in hospitalised COVID19 patients |
|
Scientific Title of Study
|
Comparison of the risk of serious adverse outcomes and clinical, laboratory and radiological characteristics in stable patients hospitalized with COVID 19 divided by co morbidity status |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nandani Gulati |
| Designation |
Attending Consultant |
| Affiliation |
Max Smart Super Speciality Hospital |
| Address |
OPD A2, Department of Pulmonary and Sleep Medicine, Ground Floor, Max Smart Super Speciality hospital, Press Enclave Marg, Saket, Delhi
South
DELHI
110017
India |
| Phone |
9158987170 |
| Fax |
|
| Email |
nandanigulati@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nandani Gulati |
| Designation |
Attending Consultant |
| Affiliation |
Max Smart Super Speciality Hospital |
| Address |
OPD A2, Department of Pulmonary and Sleep Medicine, Ground Floor, Max Smart Super Speciality hospital, Press Enclave Marg, Saket, Delhi
South
DELHI
110017
India |
| Phone |
9158987170 |
| Fax |
|
| Email |
nandanigulati@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nandani Gulati |
| Designation |
Attending Consultant |
| Affiliation |
Max Smart Super Speciality Hospital |
| Address |
OPD A2, Department of Pulmonary and Sleep Medicine, Ground Floor, Max Smart Super Speciality hospital, Press Enclave Marg, Saket, Delhi
South
DELHI
110017
India |
| Phone |
9158987170 |
| Fax |
|
| Email |
nandanigulati@gmail.com |
|
|
Source of Monetary or Material Support
|
| Max Smart Super Speciality Hospital Saket |
|
|
Primary Sponsor
|
| Name |
Max Smart Super Speciality Hospital |
| Address |
Press Enclave Marg, Saket District Centre, Saket, New Delhi, Delhi 110017 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Nandani Gulati |
Max Smart Super Speciality Hospital |
Press Enclave Marg, Saket District Centre, Saket, New Delhi, Delhi 110017
South West
DELHI |
9158987170
nandanigulati@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Max Healthcare Ethics 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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Patients testing positive for SARSCoV2 by rRTpcr on a nasopharyngeal or oro pharyngeal swab
Hemodynamically stable patients getting admitted to ward
Able and willing to provide informed consent
|
|
| ExclusionCriteria |
| Details |
Patients who meet any of the following criteria:
1. Critically ill patients defined as those
a. Requiring ICU admission
b. Requiring mech ventilation
c. Radiographic imaging with severe bilateral ground glass opacities or consol-idation
d. ARDS with PaO2/FiO2 300mm Hg or less
e. Septic Shock requiring vasopressors
f. Altered consciousness
g. Multi organ failure as evidenced by CrCL <30 ml/min or receiving HD, CVVH or ALT > 5x upper limit of normal
2. Patients not giving informed consent.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Shifted to ICU
Invasive mechanical ventilation
Death
|
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Demographics: Age/Sex/If Healthcare worker/Flu vaccination/Smoking habits
2. Symptoms: Fever/Chills/Cough/Sputum/Hemoptysis/breath shortness/GI symptoms/Skin rash/
Eyes redness/Retroorbital pain/Myalgia/Headache/Nasal congestion/Anosmia/Asymptomatic
3. Vitals: Temp/BP/HR/RR/Sensorium/Spo2 %
4. Comorbidities
5.Lab Values: TLC/KFT/LFT/Vit D/Hba1c; Severity markers: d dimer/procalcitonin/ferretin, LDH/CRP/CK/TROP I/IL6
6.Radiological: As per BSTI score
7.Los |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
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)
|
21/12/2020 |
| 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="6"
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
|
Background: The world is in the
midst of the COVID19 pandemic. There is limited data available describing
clinical, laboratory and radiological features and risk of serious adverse
outcomes in COVID19 patients in India. Furthermore, there is limited data on
the differences in presentation and outcomes of patients with COVID 19
infection in patients with and without comorbidities.
We aim to
carry out this study with the following objectives:
Primary objectives: Predicting risk
of serious adverse outcomes in mild/moderate patients hospitalized for
COVID 19 infection divided by comorbidity status.
Secondary
objectives: Comparison
of clinical, laboratory, radiological data and outcomes in stable patients with
and without comorbidities.
Rationale
for the study: COVID
19 being a novel coronavirus disease there is limited data available in India
on disease presentation and risks of serious adverse outcomes in patients with
and without comorbidities. Recently published research paper from China is
suggestive of significant difference in outcomes of these two groups with COVID
19 infection. So, by this study we would like to compare the two groups in our
Indian population.
|