Treatment of COVID-19 patients
Conditions
Interventions
Group 1: Azelastine 0.1% nasal spray, five times per day, preferentially every 3 hours
Group 2: Placebo nasal spray
Sponsors
URSAPHARM Arzneimittel GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
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 that exhibit COVID-19-related symptoms, of which a) at least two are scored at baseline with “2” or “3” OR b) at least six are scored at baseline at “1” or higher, but which have not yet lasted longer than 2 days. - Patients aged from 18 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 all study 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- 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 25, the drug will be immediately withdrawn, and patients will be discontinued from the study.
Exclusion criteria
Exclusion criteria: - 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 und 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to sustained clinical recovery, defined as (a) all symptoms from the FDA COVID-19 symptom list scored with „2“ or „3“ at baseline are subsequently scored with „0“ or „1“, AND (b) all symptoms from the FDA COVID-19 symptom list scored with „0“ or „1“ at baseline are subsequently scored as „0“, with no subsequent worsening up to Day 29 | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of COVID-19 related hospitalizations or all-cause mortality up to V6 (composite endpoint). Rate of COVID-19 related hospitalizations or all-cause mortality up to V7 (composite endpoint). Time to sustained clinical recovery, defined as (a) all symptoms from the FDA COVID-19 symptom list scored with „2“ or „3“ at baseline are subsequently scored with „0“ or „1“, AND (b) all symptoms from the FDA COVID-19 symptom list scored with „0“ or „1“ at baseline are subsequently scored as „0“, with no subsequent worsening up to Day 15 Change in symptom severity for individual symptoms up to V6 Change in symptom severity for individual symptoms between baseline, V4, V5 and V6 Persistence of COVID-19 related symptoms at V7. Change in Ct-value (measured with semiquantitative methods) between baseline and V4. Change of blood oxygen saturation from baseline up to V6 and on V7 Change in WHO status from baseline up to V6 and on V7 Frequency, severity and relationship of AEs to treatment up to V7. | — |
Countries
Bulgaria, Germany, Romania
Outcome results
None listed