A study to assess the safety and efficacy of pHoxvedic, an ayurvedic nasal drop in prevention COVID-19 infection in healthy high-risk healthcare professionals
- Registration Number
- CTRI/2021/04/032989
- Lead Sponsor
- RAPHAEL LABS LTD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 640
1. Healthcare professionals at high risk of SARS-CoV-2 exposure.
2. Normal or clinically insignificant findings during screening, medical
history, medical examination, laboratory evaluations.
3. Subjects agree to refrain from taking over the counter products
intended to prevent, intervene in, or treat colds/flu, starting at study
entry and continuing through out study.
4. Able to give voluntary informed consent for participation in the study.
1. Laboratory confirmed SARS-CoV-2 positive.
2. Laboratory confirmed IgG positive for SARS-CoV-2
3. Proven history of SARS-CoV-2 infection (laboratory confirmation by PCR
testing).
4. Previous participation in any clinical trial of a SARS-CoV-2 candidate
vaccine.
5. Subjects, who have been partially or fully vaccinated against SARS-CoV2 with any approved vaccine.
6. History of thrombocytopenia or any coagulation disorder, or subjects on anticoagulation therapy.
7. Subjects with confirmed immunosuppressive or immunodeficiency disorder; or subjects on any immunosuppressive or immunostimulant therapy.
8. Clinically significant systemic disorder such as cardiovascular, respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, hematological, psychiatric, or immunological disorder or any other
symptoms or disorder that may interfere with study objectives as per Principal Investigator discretion.
9. Subjects administered blood, blood containing products or immunoglobulins within the last 3 months or planned administration
during the study.
10. SARS-CoV-2 vaccine planned to be administered during the study
period
11. Pregnant and lactating women.
12. Participation in another clinical trial in the past 3 months.
13. History of drug / alcohol abuse.
14. Unable to complete the daily symptom tracker.
15. Unable/unwilling to follow local standard SARS-CoV-2 infection prevention measures e.g., PPE, face shield, masks etc.
16. Any nasal/sinus anatomy that will make use of the nasal spray difficult
or is symptomatic to the point where it will interfere with the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of subjects who test positive on rt-PCR for SARS-CoV-2Timepoint: Over 45 days of the study
- Secondary Outcome Measures
Name Time Method Absolute numbers of subjects with confirmed SARS-CoV-2Timepoint: Over 45 days of the study;Safety assessment via recording & reporting of: <br/ ><br>Allergies of reaction to the product (inflamed tissue etc.) <br/ ><br>Any other AE & SAE reportedTimepoint: Over 45 days of the study;Severity of disease in those confirmed SARS-CoV-2Timepoint: Over 45 days of the study;Time taken to positive test (from first dose administration) in <br/ ><br>those with confirmed SARS-CoV-2Timepoint: Over 45 days of the study;Time to symptom resolution in those confirmed SARS-CoV-2Timepoint: Over 45 days of the study;Tolerability to the IPTimepoint: Over 45 days of the study;Willingness of subjects to use formulation prior to situations of <br/ ><br>potential exposureTimepoint: Over 45 days of the study