COVID-19: Nasal spray Treatment with the well-established antiallergic Azelastine for prevention of SARS-CoV-2 INfections (CONTAIN) - CONTAI

RSAPHARM Arzneimittel GmbH0 个研究点目标入组 450 人开始时间: 2023年1月12日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•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).

发起方

RSAPHARM Arzneimittel GmbH