Phase II Clinical Study to Evaluate Safety and Efficacy of Azelastine 0.1% Nasal Spray in Non-hospitalized Patients with Mild COVID-19 Infectio
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2022/09/045465
- Lead Sponsor
- rsapharm Arzneimittel GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 294
Patients must meet all the following inclusion criteria in order to participate in this study:
1.Patients or legally accepted representative (LAR) provides informed consent prior to initiation of any study procedures.
2.Patients or LAR understands and agrees to comply with planned study procedures.
3.Male or female patients =18 years of age at the time of enrollment.
4.Patients with positive Rapid Antigen Test for SARS-CoV-2.
5.Willing to provide nasopharyngeal swabs
6.For females: non-pregnant, non-lactating with adequate contraception until Day 11, or females unable to bear children (i.e., tubal ligation, hysterectomy, or post-menopausal (defined as a minimum of one year since the last menstrual period).
Patient’s meeting any of the following criteria are not eligible for the study:
1.Having any contraindication for the use of azelastine (including hypersensitivity to the active substance or other ingredients).
2.Patients requiring hospitalization (social admission will be an exception wherein the patient could have mild symptoms requiring quarantine, but no facility is available for the same and thereby hospitalization).
3.Patients with moderate (peripheral capillary oxygen saturation [SpO2] <93%) or severe COVID-19 disease (SpO2 <90%) based on MoH FW guidelines, Revised on 23-Sep-2021.
4.Any concurrent antihistamine therapy (systemic as well).
5.Any concurrent nasal spray or any nasalia including nasal lavage fluid.
6.Inability to administer the nasal spray.
7.Patients with nasal structure abnormalities, including nasal ulceration, nasal mucosal erosion, large nasal polyps and marked septal deviations that significantly interfere with nasal airflow.
8.Patients with alcohol or drug dependence.
9.Patients receiving any concurrent anti-COVID therapy (including off-label use).
10.Where, in the opinion of the investigator, participation in this study will not be in the best interest of the patient or any other circumstances that prevent the patient from participating in the study safely
11.Specific vulnerable patients: patients who are detained or committed to institutions by law court or by legal authorities, such as psychiatric wards, prisons, or other state institutions.
12.Patients with a history of psychiatric illness.
13.Simultaneous participation in other clinical studies or previous participation within 30 days before inclusion.
14.Being in any relationship or dependence with the Sponsor, Contract Research Organization (CRO), and/or Investigator.
Note: If the RT-PCR test is negative for a patient, that patient will be taken off from the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoints of the study are: <br/ ><br>•Rate of COVID-19 related hospitalization in patients with SARS-CoV-2 infection in the treatment group as compared to control group <br/ ><br>•Decrease in mean virus load in individual patients estimated via quantitative RT-PCR by using nasopharyngeal swabsTimepoint: The primary endpoints of the study are: <br/ ><br>Rate of COVID-19 related hospitalization in patients with <br/ ><br>SARS-CoV-2 infection in the treatment group as compared to <br/ ><br>control group (up to Day 11) <br/ ><br>Decrease in mean virus load in individual patients estimated via <br/ ><br>quantitative RT-PCR by using nasopharyngeal swabs (from <br/ ><br>Baseline [Day 1] to Day 3, Day 6, and Day 11).
- Secondary Outcome Measures
Name Time Method