Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: PIRDAL Commercial name: ââ?¬Å?COVISPRAYÃ?®: Indication: protecting and cleaning osmotic liquid nasal bandage to prevent respiratory distress.
(approx. 140 sprays).
Dose: 140 sprays
fr
Sponsors
VITROBIO SAS
Mudra Clincare
Eligibility
Inclusion criteria
Inclusion criteria: 1 Male or Female patients detected positive for Covid 19 by RT-PCR test and who have no or slight nasal /respiratory clinical signs at the time of recruitment. 2 The patients aged between 18-70 at the time of screening. 3 Patients who agreed not to self- medicate with other potential preventive ARI-antivirals. ïâ??· Not currently symptomatic with an acute respiratory illness 4 Patients with Cooperative and understanding skills. 5 Patient willing to provide written informed consent. 6 Patient able to have internet access each day of the study to complete the online questionnaire 7 Patients ready to abstain from using any drug other than Investigational Product for the treatment of the studied condition, except in emergencies, in which case the responsible party must be immediately notified. Patients with moderate hypertension or diabetes may be included in the study.
Exclusion criteria
Exclusion criteria: Patients, who will meet any of the exclusion criteria, will not be included in the study. 1 Hypersensitivity/History of allergy to any of the investigational products componants 2 Any recent nasal surgery 3 Abnormal structural narrowing of sinus passages such as Deviated Nasal Septum or other kind of anatomical obstruction 4 Any unstable, serious co-existing medical condition including, but not limited to, myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within 6 months prior to the Screening visit 5 Clinical evidence of immunosuppression 6 Patient under treatment of viral disease 7 Patient with severe respiratory signs 8 Patients +ve for serum antibodies 9 Patients who have participated in other clinical studies less than 1 year prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 To assess the change in the intensity of clinical symptoms (Nasal, general, coughing and respiratory) as per the Daily Questionnaire filled directly by the patients according to their randomization number 2 The following symptoms will be scored for each patient: General: Fever, change in smell, taste appreciation, headache loss of taste, Nasal, Respiratory, Digestive 3 To assess the number of patients in each group developing minor or severe clinical signsTimepoint: From baseline to post randomization visit on days 7 and 14. | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of the patients reporting adverse events.Timepoint: From baseline to post randomization visit on days 7 to 14.;To assess the impact of PIRDAL spray on the quality of life of patients using Quality of life Questionnaire (EQ-5D-3L).Timepoint: From baseline to post randomization visit on days 7 and 14. | — |
Countries
India
Contacts
Public ContactDr S Sadgune
Mudra Clincare
Outcome results
None listed