None listed
Conditions
Interventions
Intervention1: IND02 nasal spray: one shot, 100 micrograms of IND02/100 microliter in each nostril, thrice a day for 60 days
Control Intervention1: Placebo nasal spray: one shot, 0 microgram of IND02/
Sponsors
Indus Biotech Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects population will be healthcare personnel (physicians, nurses, laboratory staff, pharmacists, technicians, stretcher-bearer, ambulance driver, respiratory therapists, administrative staff) who work in healthcare facility or any other moderate to high-risk environment (public servants like policemen, municipal corporation workers) OR relative of a patient inclusive of those with direct/primary contact with positive COVID-19 infection 2. Age 18-60 years 3. Subject has not taken any prophylaxis medication for COVID-19 in last 30 days 4.Subject agrees not to self-medicate with chloroquine, hydroxychloroquine, other potential antivirals or any other alternative medicines /supplements as a part of prevention of SARS-CoV-2 infection. 5. Willing and able to provide written informed consent prior to performing study procedures 6.Healthy at the time of enrolment without any symptoms suggestive of any viral infection 7.Negative test for COVID-19 infection by RT-PCR using ICMR/WHO protocol 8. Not previously diagnosed with COVID-19 9. Women of childbearing potential and men who partner with a woman of childbearing potential must agree to use adequate contraceptive methods.
Exclusion criteria
Exclusion criteria: 1. Subjects with a history of allergy or intolerance to Cinnamon 2. Participation in any other clinical study for COVID-19 3. Laboratory confirmed COVID-19 with or without symptoms 4. Pregnancy and Lactation mothers, and those who are planning for pregnancy 5. Patients with serious, critical illness, or severe mental illness 6. Any other condition, which the Principal Investigator thinks, may jeopardize the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of COVID-19 infection free subjects on study completion in both the groupsTimepoint: Proportion of COVID-19 infection free subjects on study completion in both the groups | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Change in General and specific health status as assessed by, WHOQOL-BREFTimepoint: At baseline, Day 30, Day 60, unscheduled visit if required ;â?¢ Change in Immune Status and Function as assessed by serology for specific anti SARS-CoV-2 IgM and IgG antibodies for all subjectsTimepoint: At baseline, Day 30, Day 60, Unscheduled Visit if required;â?¢ Proportion of subjects contracting COVID-19 during the study period. (Number of subjects having positive RT-PCR tests will be determined by comparing the serology in all subjects.Timepoint: At baseline, Day 30, Day 60 and unscheduled visit if required;â?¢ Proportion of subjects with asymptomatic cases of COVID-19 by comparing serology in all subjects.Timepoint: At baseline, Day 30, Day 60 and unscheduled visit if required;â?¢ Proportion of subjects with confirmed diagnosis of Influenza during the study periodTimepoint: At baseline, Day 30, Day 60, Unscheduled Visit if required;â?¢ To compare time to appearance of clinical symptoms of COVID-19 infections.Timepoint: At baseline, Day 30, Day 60, Unscheduled Visit if required | — |
Countries
India
Contacts
Public ContactDr Manish Rajak
Indus Biotech Private Limited
Outcome results
None listed