COVID-19 prophylaxis
Conditions
Interventions
Group 1: Azelastine 0.1% nasal spray
(One puff of IMP per nostril will be applied 3 times daily (preferentially every 6-8 hours, in the morning, at mid-day and in the evening). The nasal spray will be
Sponsors
URSAPHARM Arzneimittel GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: - Legally competent healthy volunteers who are personally capable of giving informed consent and to sign and date the Consent Form prior to any trial related activity, - Healthy volunteers aged from 18 to 65 years, whether vaccinated to SARS-CoV-2 or not. - Evidence of a negative SARS-CoV-2 Rapid Antigen Test on the day of inclusion. - No signs of acute infection (in particular of the upper respiratory tract)
Exclusion criteria
Exclusion criteria: - Simultaneous participation in other clinical trials or previous participation within 30 days before inclusion, - Being in any relationship or dependence with the Sponsor, CRO and/or Investigator (e.g. subordinate hospital personnel) - Probands showing signs of acute infection, especially of the upper respiratory tract - Probands who have had a SARS-CoV-2 infection within the last 30 days prior to inclusion in this study - Inability to understand instructions/study documents - Inability to administer the nasal spray - Subjects for whom nasal spray application is not possible or not effective due to known anatomical peculiarities - Specific vulnerable healthy volunteers: subjects who are detained or committed to institutions by law court or by legal authorities, such as psychiatric wards, prisons or other state institutions - Any additional antihistamine therapy during the treatment period (locally or systemically applied), any antihistamine therapy 7 days prior to enrolment - Any concurrent nasalia including nasal lavage fluids - Females who are pregnant, lactating, or of child-bearing potential and not using an adequate contraceptive method until Day 56. Females in post-menopausal state may be included. - Having any contraindication for the use of azelastine nasal spray (incl. hypersensitivity to the active substance or other ingredients).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Development of SARS-CoV-2 infection through day 56 (subjects are tested twice weekly for SARS-CoV-2 by rapid antigen test; positive tests are verified by PCR). | — |
Secondary
| Measure | Time frame |
|---|---|
| • Development of symptomatic SARS-CoV-2 infection through day 56 • Time to SARS-CoV-2 infection through day 56 • Duration of positivity as documented by a positive Rapid Antigen Test • Development of symptomatic upper respiratory tract infections through day 56 • Development of symptomatic infections with Influenza virus A, Influenza virus A H1N1, Influenza virus B, Rhinovirus, Endemic Human Coronaviruses 229E, NL63, HKU1, OC43, Parainfluenza viruses 1, 2, 3, 4, Human Metapneumovirus, Human Bocavirus, Mycoplasma pneumoniae, Respiratory Syncytialvirus Parechovirus, Enterovirus, Adenovirusthrough day 56 • Frequency, severity and relationship of AEs to treatment up to day 56. • Probands’ subjective and investigators’ assessment of tolerability and efficacy of the treatment at day 56 | — |
Countries
Germany
Contacts
Public ContactRobert Bals
Universitätsklinikum des Saarlandes, Klinik für Innere Medizin V
Outcome results
None listed