COVID-19 trials registries data warehouse

http://www.drks.de/DRKS00028829

Dr. Peter Meiser

info@clincompetence.de

2022-04-13

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 50 to 80 years, whether vaccinated to SARS-CoV-2 or not. Unvaccinated patients can be included only if they do not fulfil the following risk factors for a severe course of SARS-CoV-2 infection: Diabetes, obesity (BMI > 25), chronic lung disease (including asthma), chronic kidney disorder, current smoking, immunosuppressive disease or immunosuppressive therapy, heart disease,hypertension, sickle cell disease, neurodevelopmental disorders, active cancer, medical technological dependence, or age 60 years or older, regardless of comorbidities. The patient’s family physician will take the decision on the inclusion of unvaccinated patients, considering the patient’s anamnesis and concomitant medication.- Having the diagnosis of SARS-CoV-2 infection documented by a positive Rapid Antigen Test or positive PCR testing. Positive Rapid Antigen Test results must be confirmed through another Rapid Antigen test performed in presence of the investigator during the inclusion visit. Patients will be included in the study based on eligibility criteria and after signing the informed consent. The patient will undergo allstudy related procedures on the same day (baseline RT-PCR test using nasal swabs, physical examination, vital signs, concomitant medications etc) including study drug administration. The decision of continuing the patient further in the study will be decided on the results of RT-PCR (patients exhibiting baseline Ct-values = 25 will be continued, patients exhibiting baseline Ct-values > 25 will be discontinued from the study). In case of baseline Ct-values > 25, the drug will be immediately withdrawn, and patients will be discontinued from the study.

- Patients requiring hospitalization at the time of enrolment,- 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,- 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 additional antihistamine therapy from Day 1 of the trial to Day 16 (locally or systemically applied), any antihistamine therapy 7 days prior to enrolment- Any concurrent nasalia including nasal lavage fluids- Any concurrent anti-COVID therapy (including off-label use) such as (inhalative) corticosteroids or anti-viral and immune-modulatory active substances, for example Sotrovimab, Molnupiravir, Paxlovid (Nirmatrelvir and Ritonavir).- Unvaccinated patients who are eligible for therapy with already approved COVID-19 medicinal products- Females who are pregnant, lactating, or of child-bearing potential and not using an adequate contraceptive method until D60. 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).

2

URSAPHARM Arzneimittel GmbH

50

80

Germany

Mild disease at enrollment

1: Mild disease at enrollment

1000

Rate of COVID-19 related hospitalizations or all-cause mortality as a composite endpoint up to V6 (day 30).

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 3

[{"arm_notes": "nasal spray", "treatment_id": 164, "treatment_name": "Azelastine hydrochloride", "treatment_type": "Respiratory agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nasal spray", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]