Health Condition 1: J00-J99- Diseases of the respiratory system Health Condition 2: J069- Acute upper respiratory infection,unspecified
Conditions
Interventions
Intervention1: CoviFightâ?¢ Liquid Nasal Spray: The CoviFightâ?¢ Liquid nasal spray is a nasal spray that releases nitric oxide gas (gNO).
Nasal spray is to be self administered by patients into both
Sponsors
Meril Diagnostics Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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 Investigatorâ??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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of change in SARS-CoV-2 viral load at 7 days from baseline through qRT-PCR test between patients receiving COVIFIGHT versus those receiving placebo.Timepoint: at 7 days from baseline through qRT-PCR test | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Comparison of change in SARS-CoV-2 viral load. 2. Comparison of number of patients reaching Ct threshold (un-measurable viral load). 3. Number of patients requiring hospitalization for COVID-19/flu-like symptoms and/or requiring oxygen therapy or intubation or non-invasive ventilation or mechanical ventilation following enrollment. 4. Adverse events and Serious adverse events. â?? Number and type of adverse events and serious adverse events related to the study. 5. Patient reported outcome (PRO): â?? To assess common COVID-19 related symptoms using PRO questionnaire. 6. Time to clinical recovery: â?? Determining the time for clinical recovery by: Normalization of fever ( 99° F) Measurement of oxygen saturation at room air (SpO2 95%) Resolution of flu-like symptoms 7. Number of patients with negative conversion of SARS-CoV-2.Timepoint: 1. Time Frame: 24 hours, day 3, day 4 and day 7 from baseline 2. Time Frame: 24 hours, day 3, day 4, day 5 and day 7 from baseline 3. Time Frame: Through 15 days 4. Time Frame: Through 15 days 5. Time Frame: Baseline, 24 hours, day 3, day 4, day 5, day 7 and day 15 6. Time Frame: Through 15 days 7. Time Frame: day 3, day 4, day 5 and day 7 | — |
Countries
India
Contacts
Public ContactDr Ashok Thakkar
Meril Life Sciences Pvt. Ltd.
Outcome results
None listed