Created at Source Raw Value Validated value
July 28, 2021, 4:30 p.m. eu

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).

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).