| CTRI Number |
CTRI/2021/03/032471 [Registered on: 31/03/2021] Trial Registered Prospectively |
| Last Modified On: |
03/06/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective Analysis |
| Study Design |
Other |
|
Public Title of Study
|
Data Analysis of THINQURE 20 in COVID 19 Patients |
|
Scientific Title of Study
|
A Non-Interventional, Retrospective, Observational Study to Analyze Safety, Efficacy and Tolerability of THINQURE 20 in COVID-19 Patients. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pravin Nagulal Soni |
| Designation |
Principal Investigator |
| Affiliation |
YCM Hospital pune |
| Address |
Room no 03 2nd floor Department of Medicine YCM Hospital Rd, Sant Tukaram Nagar, Pimpri Colony, Pune, Maharashtra 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9822057511 |
| Fax |
|
| Email |
pravinsoni028@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravindra Mote |
| Designation |
Director |
| Affiliation |
Mediclin Clinical Research |
| Address |
4thFloor Ambika Idustries Opp. Thakur Mall Penkarpada Rd Mira Road Maharashtra 401104
Thane
MAHARASHTRA
401107
India |
| Phone |
8888884024 |
| Fax |
|
| Email |
ravindra.mote@mediclincr.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Milind Gharpure |
| Designation |
Senior General Manager |
| Affiliation |
Thinq Pharma CRO Limited |
| Address |
A30 Rd Number 10 Wagle Estate MIDC Thane West Thane Maharashtra 400604
Thane
MAHARASHTRA
400604
India |
| Phone |
9820726954 |
| Fax |
|
| Email |
milindgharpure594@gmail.com |
|
|
Source of Monetary or Material Support
|
| Thinq pharma CRO Limited, A30, Rd Number 10, Wagle Estate, MIDC, Thane West, Thane, Maharashtra 400604, India. |
|
|
Primary Sponsor
|
| Name |
Thinq Pharma CRO Limited |
| Address |
A30 Rd Number 10 Wagle Estate MIDC Thane West Thane Maharashtra 400604 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Pravin Soni |
YCM Hospital Pune |
Room no 03 2nd floor Department of Medicine YCM Hospital Rd, Sant Tukaram Nagar, Pimpri Colony, Pune, Maharashtra 411018
Pune
MAHARASHTRA |
9822057511
pravinsoni028@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethicare 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
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
We will consider the following criteria for retrospective analysis.
1. Male or Female subjects of age 18 to 75 years (both inclusive).
2. Subjects diagnosed with COVID-19 by RT-PCR.
3. Patients provided oral & nasal swabs for test
4. Females of child-bearing potential (i.e., who were not chemically or surgically sterilized or who were not post-menopause) must have had a negative urine pregnancy test.
5. Females of child-bearing potential who have used a medically accepted method of contraception that was considered reliable in the judgment of the investigator.
6. Subjects who have taken Thinqure 20 as prescribed by Investigator.
|
|
| ExclusionCriteria |
| Details |
Subjects were excluded on the following basis:
1. Patients with a history of intracranial bleeding
2. Patients without a completed medical history
3. Patients, who were suffering from any haemoglobinopathies such as thalassemia that could interfere with oxygen carriage in the blood.
4. Patients, who were smokers or consumed alcohol.
5. Patients, who were suffering from active malignancy along with squamous cell or basal cell skin cancer.
6. Female subjects who were pregnant or lactating or planning to become pregnant during the study period.
7. Females who were not ready to use acceptable contraceptive methods during the course of study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in viral load from baseline to end of study visit. |
Day 1 to Day 5 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The assessment of safety and tolerability of Investigational Product. |
Day 1 to Day 5 |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/04/2021 |
| Date of Study Completion (India) |
16/11/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
A Non-Interventional, Retrospective, Observational study to analyze safety, efficacy and tolerability of THINQURE 20 in COVID-19 patients. Base on data available we want to analyze THINQURE 20 in COVID-19 patients. Based on data analysis we will go for a pivotal study |