Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Azelastine 0.1% nasal spray: 1 mg/mL azelastine hydrochloride (0.1% Azelastine HCl)
one puff of study treatment
(i.e., Azelastine 0.1% nasal spray) to be self-administered by the patien
Sponsors
Ursapharm Arzneimittel GmbH
Eligibility
Inclusion criteria
Inclusion criteria: 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).
Exclusion criteria
Exclusion criteria: 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] 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints of the study are: •Rate of COVID-19 related hospitalization in patients with SARS-CoV-2 infection in the treatment group as compared to control group •Decrease in mean virus load in individual patients estimated via quantitative RT-PCR by using nasopharyngeal swabsTimepoint: The primary endpoints of the study are: Rate of COVID-19 related hospitalization in patients with SARS-CoV-2 infection in the treatment group as compared to control group (up to Day 11) Decrease in mean virus load in individual patients estimated via quantitative RT-PCR by using nasopharyngeal swabs (from Baseline [Day 1] to Day 3, Day 6, and Day 11). | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome of the study are: • Safety assessment (occurrence of adverse events [AEs]) (post-randomization till Day 30). Safety assessments of patients who report COVID symptoms of mild COVID-19 on Day 30 will also be taken on Day 60 (±1 day) through a telephonic call • Proportion of patients demonstrating a 10-fold decrease in virus load of SARS-CoV-2 • Ct values o The Ct value shall be plotted on a graph for all patients. o The change in Ct value will be calculated over the treatment period o Rate of decline of Ct values o Time to Cure • Change in symptom severity (symptom score based on MoH FW checklist) • The change in patient status using a 11-category ordinal score as proposed by the World Health Organization (WHO) • The change in patient status by measurement of temperature (fever) and oxygen saturation of the blood by use of a finger pulse oxymeter • Proportion of subjects with negative conversion of SARS-CoV 2 RT PCR Timepoint: Safety assessment (post- randomization till Day 30). Safety assessments of patients on Day 30 will be taken on Day 60 (±1 day) through a telephonic call. Proportion of patients demonstrating 10-fold decrease in virus load , Ct values and change in Ct value will be calculated over treatment period. Change in symptom severity, change in patient status using 11- category ordinal score, measurement of temperature (fever) and SpO2 (from Baseline [Day 1] to Day 3, Day 6, and Day 11) | — |
Countries
India
Contacts
Public ContactDr Rajesh Jain
PharmaLex India Pvt. Ltd.
Outcome results
None listed