| CTRI Number |
CTRI/2021/04/032904 [Registered on: 19/04/2021] Trial Registered Prospectively |
| Last Modified On: |
16/04/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To see if Remdesivir, an antiviral drug helped in reducing the hospital stay and helped patients with COVID 19infection recover faster? |
|
Scientific Title of Study
|
To study the clinical outcomes in hospitalized patients, receiving Remdesivir for moderate/severe COVID 19 infection, during August 2020 to October 2020 in a designated COVID hospital.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Punam Bhende |
| Designation |
Assistant Professor |
| Affiliation |
H M Centre for Medical Care and Research |
| Address |
15 Shashwath Florence
Opposite Shree Krishna Hospital
Karamsad Anand
Gokal Nagar Karamsad 388325
Anand
GUJARAT
388325
India |
| Phone |
9480703214 |
| Fax |
|
| Email |
punamvb@charutarhealth.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Punam Bhende |
| Designation |
Assistant Professor |
| Affiliation |
H M Centre for Medical Care and Research |
| Address |
15 Shashwath Florence
Opposite Shree Krishna Hospital
Karamsad Anand
Gokal Nagar Karamsad 388325
GUJARAT
388325
India |
| Phone |
9480703214 |
| Fax |
|
| Email |
punamvb@charutarhealth.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Punam Bhende |
| Designation |
Assistant Professor |
| Affiliation |
H M Centre for Medical Care and Research |
| Address |
15 Shashwath Florence
Opposite Shree Krishna Hospital
Karamsad Anand
Gokal Nagar Karamsad 388325
GUJARAT
388325
India |
| Phone |
9480703214 |
| Fax |
|
| Email |
punamvb@charutarhealth.org |
|
|
Source of Monetary or Material Support
|
| Shree Krishna Hospital and stationary expense will be borne by the investigator |
|
|
Primary Sponsor
|
| Name |
Dr Punam Bhende |
| Address |
15 Shashwath Florence Opposite Shree Krishna Hospital Karamsad Anand 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 Punam Bhende |
Shree Krishna Hospital |
H M Patel Centre for Medical Care and Research, Gokal Nagar, Karamsad
Anand
GUJARAT |
9480703214
punamvb@charutarhealth.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC 2 H M Patel Centre for Medical Care and Research |
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: J128||Other viral pneumonia, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Death, Discharge, Length of stay in hospital, duration of O2therapy |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| the results will help in decision making and add to existing treatment protocols |
3 months |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
20/04/2021 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
will be published in standard journal . deidentified data will be presented. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is an observational study, wherein we will go through records of patients admitted with moderate and severe COVID infection in our hospital and received remdesivir ,during the period specified. Comorbidities, age, duration of symptom onset and presentation to the hospital will be noted. Hospital stay, outcome- discharge/ death/ duration of oxygen requirement will also be studied. This is to see the clinical outcomes in patients receiving Remdesivir. |