To evaluate the clinical efficacy and safety of COVIFIGHT Liquid nasal spray in reducing viral load in non hospitalised COVID-19 patients.
- Conditions
- Health Condition 1: J069- Acute upper respiratory infection,unspecifiedHealth Condition 2: J00-J99- Diseases of the respiratory system
- Registration Number
- CTRI/2023/08/057043
- Lead Sponsor
- Meril Diagnostics Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Patient =18 years of age.
2. Patient or their legal representative are willing to provide consent to participate in the study.
3. Patients with positive SARS-CoV-2 infection by antigen and qRT-PCR test (confirmed within 48 hours of randomization).
4. Patients presenting with mild SARS CoV-2 symptoms which may include but not limited to fever, cough, sore throat, fatigue, headache, muscle pain, diarrhea, nausea and vomiting, abdominal pain, lack of taste or smell, shortness of breath (within 48 hours of symptom onset) or no symptoms.
1. Any clinical contraindications as judged by the Investigator.
2. Patient with concomitant respiratory therapy (oxygen or ventilator support).
3. Patient with prior SARS CoV-2 infection ( >48 hours from the time of screening).
4. Patients with severe or critical SARS CoV-2 severity symptoms and/or requiring hospitalization at the time of enrolment.
5. Lactating or pregnant women.
6. Patients on anti-platelet therapy.
7. Patients with pre-existing left ventricular dysfunction based on Investigator’s discretion.
8. Patients on nitric oxide donor compound therapy (sodium nitroprusside and nitroglycerin or prilocaine)
9. Patients with recent nasal surgeries or abnormalities in the nasal structure that might interfere with drug administration.
10. Patients with history of pollen allergy.
11. Patients on vasodilator therapy.
12. Patients with respiratory disorders like asthma, Chronic obstructive pulmonary disease (COPD) etc or history of pneumonia within 3 months of screening.
13. Patients with Stage-II Acute Kidney Injury
14. Patients vaccinated for COVID-19
15. Known allergy/hypersensitivity to Nitric Oxide
16. Not participating in any investigational drug or device study until completion of this study.
17. Patient on any intranasal medication or received any within last 7 days prior to screening
18. Patient on any anti-viral medication or received any within last 7 days prior to screening
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method