Double-blind placebo-controlled proof-of-concept trial to demonstrate the anti-viral efficacy of different doses of azelastine in COVID-19 positive patients.
- Conditions
- Diagnosis of SARS-CoV-2 infection documented by a positive PCR test (patients do not need to suffer from COVID-19 symptoms)MedDRA version: 23.1Level: PTClassification code 10084460Term: COVID-19 treatmentSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2020-005544-34-DE
- Lead Sponsor
- RSAPHARM Arzneimittel GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 90
Patients must meet all of the following inclusion criteria in order to participate in this study:
- Legally competent patients who are personally capable of giving informed consent and to date the Consort Form prior to any trial related activity
- Patients aged from 18 - 60 years
- Having the diagnosis of SARS-CoV-2 infection documented by a positive PCR test (patients do not need to suffer from COVID-19 symptoms)
- Enrolment only permitted on the day of availability of positive COVID-19 PCR test result, and on the subsequent day, however, not longer than 48 hours after the swab was taken
- For females: non-pregnant, non-lactating with adequate contraception until D16, or females unable to bear children (i.e., tubal ligation, hysterectomy, or post-menopausal (defined as a minimum of one year since the last menstrual period).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method