Diagnosis of SARS-CoV-2 infection documented by a positive PCR test (patients do not need to suffer from COVID-19 symptoms) MedDRA version: 23.1 Level: PT Classification code 10084460 Term: COVID-19 treatment System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: Pollival® 1 mg/ml Nasenspray, Lösung
Pharmaceutical Form: Nasal spray, solution
INN or Proposed INN: Azelastinhydrochlorid
Other descriptive name: AZELASTINE HYDROCHLORIDE
Concentration un
Sponsors
URSAPHARM Arzneimittel GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must meet all of the following inclusion criteria in order to participate in this study: - Legally competent patients who are personally capable of giving informed consent and to date the Consort Form prior to any trial related activity - Patients aged from 18 - 60 years - Having the diagnosis of SARS-CoV-2 infection documented by a positive PCR test (patients do not need to suffer from COVID-19 symptoms) - Enrolment only permitted on the day of availability of positive COVID-19 PCR test result, and on the subsequent day, however, not longer than 48 hours after the swab was taken - For females: non-pregnant, non-lactating with adequate contraception until D16, 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). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 90 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients must not meet any of the following non-inclusion criteria in order to participate in this study: - Patients requiring hospitalization, - Simultaneous participation in other clinical trials or previous participation within 30 days before inclusion, - No enrolment permitted if COVID-19 testing was performed more than 48 hours ago - Being in any relationship or dependence with the Sponsor, CRO and/or Investigator, - Patients being on risk for a serious course of the disease (e.g., insulin-dependent diabetic patients, patients treated with antihypertensive drugs), - Inability to understand instructions/study documents, - Inability to administer the nasal spray - Specific vulnerable patients: subjects who are detained or commited to institutions by law court or by legal authorities, such as psyhiatric wards, prisons or other state institutions - Any concurrent anti-histamine therapy (systemic as well) - Any concurrent nasal spray - Females who are pregnant, lactating, or of child-bearing potential and not using an adequate contraceptive method until D16, - Having any contraindication for the use of azelastine (incl. hypersensitivity to the active substance or other ingredients).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to assess the first data on efficacy of azelastine nasal spray in SARS-CoV-2 infected patients with regards to virus load in nasopharyngeal swabs. ;Secondary Objective: Secondary objectives of the trial are: - To assess the clinical impact of the treatment with azelastine nasal spray with regards to the SARS CoV-2 virus shedding. - To assess the clinical impact of the treatment with azelastine nasal spray with regard to symptoms via a patient diary. - To assess the clinical improvement of the patient state - To assess the clinical impact of the treatment with azelastine nasal spray with regards to Quality of Life ;Primary end point(s): Primary Endpoint First data on efficacy of the treatment with azelastine nasal spray will be assessed by the decrease in median virus load of SARS-CoV-2 between the treatment groups via regular quantitative PCR measurements from nasopharyngeal swabs. Primary endpoint of the efficacy of azelastine nasal spray in COVID-positive patients is the baseline adjusted course of the median of virus load in nasopharyngeal swabs of the three treatment groups at any of the six timepoints (day 2, day 3, day 4, day 5, day 8 and day 11) after baseline (day 1). Comparisons will be made via regularly performed quantitative PCR measurements from nasopharyngeal swabs. ;Timepoint(s) of evaluation of this end point: Any of the six timepoints (day 2, day 3, day 4, day 5, day 8 and day 11) after baseline (day 1) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Endpoints Clinical impact endpoints will include: 1. Proportion of patients who show a 10-fold decrease in virus load of SARS-CoV-2 within 3 days of treatment 2. Change in symptom severity (anosmia, ageusia, fever, cough, sore throat, shortness of breath, coryza, general weakness, headache, aching limbs, loss of appetite, pneumonia, nausea, abdominal pain, vomiting, diarrhoea, conjunctivitis, rash, lymph node swelling, apathy, somnolence) from baseline 3. The change in patient status using a 11-category ordinal score as proposed by the WHO 4. The change in patient status by measurement of temperature (fever) and oxygen saturation of the blood 5. The change in quality of life as assessed by the SF-36 generic quality of life questionnaire 6. Safety assessment (occurrence of adverse events) ;Timepoint(s) of evaluation of this end point: 1. 3 days of treatment 2. at any visit from baseline (day 1, day 2, day 3, day 4, day 5, day 8, day 11) 3. at any visit from baseline (day 1, day 2, day 3, day 4, day 5, day 8, day 11) 4. at any visit from baseline (day 1, day 2, day 3, day 4, day 5, day 8, day 11) 5. at visit (day 1, day 5, day 8 day 11) 6. over the entire study period | — |
Countries
Germany
Contacts
Public ContactContract Research Organization
ClinCompetence Cologne GmbH
Outcome results
None listed