Double-blind placebo-controlled proof-of-concept trial to demonstrate the anti-viral efficacy of different doses of azelastine in COVID-19 positive patients

Phase 2

Conditions: U07.1
COVID-19, virus identified

Registration Number: DRKS00024520

Lead Sponsor: RSAPHARM Arzneimittel GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 90

Inclusion Criteria

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).

Exclusion Criteria

- 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).

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
1. Proportion of patients who show a 10-fold decrease in virus load of SARS-CoV-2 within 3 days of treatment <br>2. Change in symptom severity (anosmia, ageusia, fever, cough, sore throat, shortness of breath, coryza, general weakness, headache, aching limbs, loss of appetite, pneumonia, nausea, abdominal pain, vomiting, diarrhoea, conjunctivitis, rash, lymph node swelling, apathy, somnolence) from baseline<br>3. The change in patient status using a 11-category ordinal score as proposed by the WHO <br>4. The change in patient status by measurement of temperature (fever) and oxygen saturation of the blood<br>5. The change in quality of life as assessed by the SF-36 generic quality of life questionnaire<br>6. Safety assessment (occurrence of adverse events)

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