None listed
Conditions
Interventions
None listed
Sponsors
ITC Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Individuals 12 years and above, living with individuals with Lab confirmed COVID-19 infection. 2.Individuals with no clinical symptoms and negative RT-qPCR for COVID19 (SARS CoV-2), insignificant findings during screening, medical history, medical examination, laboratory evaluations. 3.Individuals agreeing to refrain from taking over the counter products intended to prevent, intervene in, or treat colds/flu, starting at study entry and continuing through the study course. 4.Individuals willing to use an adequate form of contraception (or abstinence) from the time of the first dose with the IP until after the end of study course.
Exclusion criteria
Exclusion criteria: 1.Pregnant / lactating women. 2.Individuals undergoing active cancer / biological/ hormonal treatment. 3.Individuals previously vaccinated (1/2 doses) against COVID-19 (SARS CoV-2)/ recently vaccinated. 4.Individuals previously confirmed positive for COVID-19 (SARS CoV-2). 5.Individuals having previously participated in any clinical trial for COVID19 (SARS-CoV-2) in last three months. 6.Individuals with history of sinusitis, issues with nasal septum or nasal epithelium conditions. 7.Individuals with any organ transplantation/ History of thrombocytopenia or any coagulation disorder/ History of allergies / sensitivities to any active ingredient of study IP. 8.Individuals suffering from asthma / taking regular medications administered by inhalation, or via the nasal and oropharyngeal route. ââ?¬Â¢ Individuals with Immuno compromised state/ those under immune stimulant therapy. 9.Patients who have any untreated/uncontrolled reversible medical condition which may cause any harm as per the Investigatorââ?¬•s clinical judgement.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Percentage of subjects who test positive on RT-qPCR/ RAT/IgG/IgM for COVID-19 over the 30 days of the study. Timepoint: Over the 30 days of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Percentage (%) of care givers who remained negative after prolonged exposure to COVID-19 positive patients during the study in either Arm. 2. Difference of CT value for subjects who tested positive during the study between test and placebo arm. 3. Severity of disease in those confirmed with COVID-19. 4.Safety assessment via recording & reporting of Tolerability to the IP 5. Any other AE and SAE during study course Timepoint: over 30 days of the study. | — |
Countries
India
Contacts
Public ContactMeena Dalal
Trial Guna Pvt Ltd
Outcome results
None listed