Created at Source Raw Value Validated value
Feb. 27, 2021, 12:45 a.m. oms

- 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 committed to institutions by law court or by legal authorities, such as psychiatric 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).

- 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 committed to institutions by law court or by legal authorities, such as psychiatric 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).