NCT05118763

Intranasal INNA-051 for Prevention of COVID-19 in Adults

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety, Tolerability, and Efficacy of Intranasal INNA-051 for Prevention of COVID-19 in Adults Following Close Contact With Individuals With SARS-CoV-2 Infection

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: ENA Respiratory Pty Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 2, randomized, double-blind, placebo-controlled study of INNA-051 in adults following household contact with an individual with RT-PCR confirmed SARS CoV-2 infection. This study will evaluate 2 active dose levels of INNA-051 and placebo.

Detailed description

Adults who have a household member with RT-PCR-confirmed SARS-CoV-2 infection and have been in close contact, and who test negative to SARS-CoV-2, will be randomized. Participants will receive 4 doses of study medication over a 10 day period, and complete symptoms scores and questionnaires. Development of COVID-19 symptoms will require collection of a nasal swab for RT-PCR testing. Telephone visits will occur on Days 2, 4, 10, 21, 28, and 35. Additional visits will occur on Days 7, 14, and 42 (end of study).

Conditions

• COVID-19 Pandemic

Interventions

Type	Name	Description
DRUG	INNA-051	Liquid for intranasal administration
OTHER	Placebo	Liquid for intranasal administration

Timeline

• Start date: 2022-03-01
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2021-11-12
• Last updated: 2022-04-14

Regulatory

• FDA-regulated drug study