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Pirdal Nasal Spray in preventing symptomatic manifestation of disease in Covid-19 proven cases
CTRI; 26-11-2020; TrialID: CTRI/2020/11/029388
Clinical Trial Register | ICTRP | ID: ictrp-CTRI202011029388
ABSTRACT

Condition

Health Condition 1 B972- Coronavirus as the cause of diseases classified elsewhere

Intervention

Intervention1 PIRDAL Commercial name ´COVISPRAY® Indication protecting and cleaning osmotic liquid nasal bandage to prevent respiratory distress.
(approx. 140 sprays).
Dose 140 sprays
frequency route of administration 2-3 sprays in each nostril
duration of therapy is 14 days.



Primary 

outcome:

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.

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. ï?· 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 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.
Collection: Clinical trial registers Database: ICTRP Type of study: Controlled clinical trial Year: 2020 Document Type: Clinical Trial Register

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Collection: Clinical trial registers Database: ICTRP Type of study: Controlled clinical trial Year: 2020 Document Type: Clinical Trial Register