Trial DRKS00024520; EudraCT 2020-005544-34
Publication - Klussmann J, 2021 (preprint)
Dates: 3/9/2021 to 4/28/2021
Funding: Private (URSAPHARM Arzneimittel GmbH, Saarbrücken, Germany and CEBINA GmbH Vienna, Austria.)
Conflict of interest: Yes

Methods
RCT
Blinding: double blinding
Location : Single center / Germany
Follow-up duration (days): 11
Inclusion criteriaAged 18-60 years; positive PCR test for SARS-CoV-2 within 48 hours prior to inclusion; Females: non-pregnant, non-lactating, with adequate contraception or unable to bear children; had to quarantine at home due to instructions of the local health authority.
Exclusion criteriaHospitalization; Simultaneous participation in other clinical trial or previous participation within 30 days before inclusion; Relationship or dependence with the Sponsor, CRO and/or Investigator; Risk of serious course of the disease (e.g. insulin- dependent diabetic patients, use of antihypertensive drugs); Inability to understand instructions/study documents; Inability to administer the nasal spray; Vulnerable patients: detained or committed to institutions by law court or legal authorities; Females: pregnant, lactating, or of child-bearing potential and not using an adequate contraceptive method; Concurrent anti-histamine therapy; Concurrent nasal spray; Contraindication for the use of azelastine (incl. hypersensitivity to the active substance or other ingredients).
Interventions
Treatment 1
Azelastine 0.02
Control
Placebo
Treatment 3
Azelastine 0.1
Participants
Randomized
90 participants n1=30/ n2=30/ n3=30
Characteristics of participants
N=90
Mean age : NR
* males
Severity : Mild: n=* / Moderate: n=0/ Severe: n=0 Critical: n=0
Primary outcome
In the register
decrease in median virus load of SARS-CoV-2 at any of the six timepoints (day 2, day 3, day 4, day 5, day 8 and day 11) after baseline (day 1)
In the report
NR
Documents
available

Protocol

Yes. In English

Statistical plan

Yes

Data-sharing stated

NR
Risk of bias
Overall
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
*
General comment This trial is pending contact with authors. No review-specific outcomes were reported.
In addition to the pre-print article, the study registry, protocol, statistical analysis plan and supplementary appendices were used in data extraction and assessment of risk of bias. The primary outcome in the registries was defined as median viral load, whereas the analysis in the article focuses on mean load. There were no major changes in secondary outcomes. This was a preliminary analysis of data to day 11, with full outcomes to 60 days to be reported later. The baseline characteristics and disease severity (symptomatic/asymptomatic) were not reported. No outcomes COVID-NMA outcomes were reported in this preliminary report.