Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: CitrobioSheild: organic citrus extract (Bioflavonoid Complex).
Dosage regimen: Inhalation by fogging for 3 mins per day for 7 days with 10% solution and a rate of 50 ml/min.
Control In
Sponsors
GERMKILL INDIA
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or non-pregnant female between 18 to 65 years of age at the time of enrolment. 2. Subject or LAR providing written informed consent and agrees to follow study procedure. 3. Woman with child bearing potential confirming use of primary contraception 4. Mild to moderate freshly confirmed COVID 19 positive subjects in less than 24 hours not requiring emergency or ICU care at the time of enrolment
Exclusion criteria
Exclusion criteria: 1. Severe COVID 19 patients requiring ventilation or oxygen support when diagnosed. 2. Females who are planning to conceive during the study duration or are pregnant already or are breastfeeding. 3. Subjects having serious or unstable respiratory disorders (self-reported) 4. Subject already on immune therapy (self-reported) 5. Immunodeficiency or organ transplant (self-reported) 6. Autoimmune disease (self-reported) 7. Current acute infection or exacerbation of a chronic illness (self-reported) 8. Cancer within last 5 years (self-reported) 9. Known infection with HIV, Hepatitis B & Hepatitis C (self-reported) 10. Drug abuse/alcohol abuse (self-reported) 11. Plasma donation within last 4 months (self-reported) 12. Receiving blood or immunoglobulins within 3 months (self-reported) 13. SGOT/SGPT greater than 5 times normal value (self-reported)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The time taken to relieve the individual symptoms in both the groups. (fever, dry cough, tiredness, aches and pains, sore throat, diarrhoea, headache, loss of taste or smell, difficulty breathing or shortness of breath, chest pain or pressure) after 7 days. 2. Change in everyday clinical status of the subjects on a 7-point ordinal scale during the course of 7 days Timepoint: 7 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinically significant change in the following safety parameters from baseline to EOT: a. SGOT b. SGPT c. CBC d. Serum Creatinine e. Vitals f. Occurrence of any AE/ SAE during the treatment duration. Additional analysis Endpoint: Clinically significant Quantitative Reduction of Viral load from baseline to EOT on exposed surface (hand surface, masks, bed sheets, PPE kits, etc). Timepoint: 7 days | — |
Countries
India
Contacts
Public ContactSubham Dutta
GERMKILL INDIA
Outcome results
None listed