COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-005544-34/DE

ClinCompetence Cologne GmbH - Contract Research Organization

info@clincompetence.de

2020-12-28

Completed

RCT

Randomized

Parallel

Blind label

single-center

Treatment

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).

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).

3

URSAPHARM Arzneimittel GmbH

18

60

Germany

Mild disease at enrollment

1: Mild disease at enrollment

90

Primary Endpoint 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. Primary endpoint of the efficacy of azelastine nasal spray in COVID-positive patients is the baseline adjusted course of the median of virus load in nasopharyngeal swabs of the three treatment groups at any of the six timepoints (day 2, day 3, day 4, day 5, day 8 and day 11) after baseline (day 1). Comparisons will be made via regularly performed quantitative PCR measurements from nasopharyngeal swabs.

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

Phase 2

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