CTRI/2021/03/032471CompletedNot Applicable
A Non-Interventional, Retrospective, Observational Study to Analyze Safety, Efficacy and Tolerability of THINQURE 20 in COVID-19 Patients.
Thinq Pharma CRO Limited1 site in 1 country25 target enrollmentStarted: December 4, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Thinq Pharma CRO Limited
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Reduction in viral load from baseline to end of study visit.
Study Overview
Brief Summary
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
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 75.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •We will consider the following criteria for retrospective analysis.
- •Male or Female subjects of age 18 to 75 years (both inclusive).
- •Subjects diagnosed with COVID-19 by RT-PCR.
- •Patients provided oral & nasal swabs for test
- •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.
- •Females of child-bearing potential who have used a medically accepted method of contraception that was considered reliable in the judgment of the investigator.
- •Subjects who have taken Thinqure 20 as prescribed by Investigator.
Exclusion Criteria
- •Subjects were excluded on the following basis:
- •Patients with a history of intracranial bleeding
- •Patients without a completed medical history
- •Patients, who were suffering from any haemoglobinopathies such as thalassemia that could interfere with oxygen carriage in the blood.
- •Patients, who were smokers or consumed alcohol.
- •Patients, who were suffering from active malignancy along with squamous cell or basal cell skin cancer.
- •Females who were not ready to use acceptable contraceptive methods during the course of study.
Outcomes
Primary Outcomes
Reduction in viral load from baseline to end of study visit.
Time Frame: Day 1 to Day 5
Secondary Outcomes
- The assessment of safety and tolerability of Investigational Product.(Day 1 to Day 5)
Investigators
Study Sites (1)
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