COVID-19: Nasal spray Treatment with the well-established antiallergic Azelastine for prevention of SARS-CoV-2 INfections (CONTAIN)
- Conditions
- COVID-19 prophylaxis
- Registration Number
- DRKS00031059
- Lead Sponsor
- RSAPHARM Arzneimittel GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 450
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)
- 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).
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Development of SARS-CoV-2 infection through day 56<br>(subjects are tested twice weekly for SARS-CoV-2 by rapid antigen test; positive tests are verified by PCR).
- Secondary Outcome Measures
Name Time Method • Development of symptomatic SARS-CoV-2 infection through day 56<br>• Time to SARS-CoV-2 infection through day 56 <br>• Duration of positivity as documented by a positive Rapid Antigen Test<br>• Development of symptomatic upper respiratory tract infections through day 56<br>• 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<br>• Frequency, severity and relationship of AEs to treatment up to day 56.<br>• Probands’ subjective and investigators’ assessment of tolerability and efficacy of the treatment at day 56<br>