COVID-19 trials registries data warehouse

http://www.drks.de/DRKS00024520

Peter Meiser

silke.allekotte@clincompetence.de

2021-02-12

Not recruiting

RCT

Randomized

Parallel

Blind label

single-center

Treatment

- Legally competent patients who are personally capable of giving informed consent and to sign and date the Consent 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).

- 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).

3

URSAPHARM Arzneimittel GmbH

18

60

Germany

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

90

First data on efficacy of the treatment with azelastine nasal spray will be assessed by the decrease in median virus load of SARS-CoV-2 between the treatment groups via regular quantitative PCR measurements from nasopharyngeal swabs.

| Declared number of arm (3.0) differs from found arms (4.0)

Phase 2

[{"arm_notes": "1mg/ml", "treatment_id": 164, "treatment_name": "Azelastine hydrochloride", "treatment_type": "Respiratory agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "0.2mg/ml", "treatment_id": 164, "treatment_name": "Azelastine hydrochloride", "treatment_type": "Respiratory agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]