NCT05035576

A Study to Evaluate Change in Viral Load After OPN-019 in Adults With COVID-19

A Randomized, Adaptive Design, Proof of Concept, Single Dose Study to Evaluate Change in Viral Load After OPN-019 in Adults With COVID-19

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Optinose US Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine both the magnitude and duration of viral load (copies/mL) reduction after a single dose of OPN-019. The variability associated with viral counts will be utilized to inform the study design of future studies.

Detailed description

A randomized, single dose, adaptive design, proof of concept study in subjects who have tested positive for SARS-CoV-2 infection, are recently infected, and who have mild or no symptoms. Patients will be required to have a score ≤ 2 on the WHO ordinal scale for clinical improvement (Covid-19 Therapeutic Trial Synopsis; Feb 18, 2020). Those meeting the inclusion criteria will be randomized to 1 of 2 arms: OPN-019 (2 sprays per nostril) or SOC. Once randomized, subjects will have baseline nasal and oropharyngeal swabs performed for qRT-PCR viral load and infectious viral particle assessment. The subject will then be administered the study medication. Subsequent nasal and oropharyngeal swabs will be taken at 1 hour, 3 hours, 6 hours, 8 hours, 12 hours, and 24 hours. Cohorts of 10 subjects will be randomized into the study and the results from those subjects will be evaluated to determine if changes in the inclusion criteria or study assessments are required.

Conditions

• Covid19

Interventions

Type	Name	Description
DRUG	OPN-019	400 mg OPN-019, 2 sprays per nostril (one dose)

Timeline

• Start date: 2021-09-01
• Primary completion: 2021-11-30
• Completion: 2021-11-30
• First posted: 2021-09-05
• Last updated: 2022-05-02

Locations

1 site across 1 country: Mexico