NCT04460183

A Study to Assess Efficacy and Safety of RESP301 Plus Standard of Care (SOC) Compared to SOC Alone in Hospitalized Participants With COVID-19

An Open-label, Adaptive Randomized, Controlled Multicenter Study to Evaluate the Efficacy and Safety of RESP301 Plus Standard of Care (SOC) Compared to SOC Alone in Hospitalized Participants With COVID-19 WHO Grade 3&4 (NOCoV2)

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Thirty Respiratory Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The effect of RESP301 as an add on treatment to SOC will be evaluated for its efficacy in reducing rate of progression to a more severe level of COVID-19 and for safety, by comparison with SOC alone in hospitalized COVID-19 patients.

Detailed description

This is an open-label, randomized, multicenter, parallel group, concurrent, controlled study using a sequential adaptive design to evaluate the efficacy and safety of RESP301 plus SOC versus SOC alone in hospitalized patients with COVID-19 (World Health Organization \[WHO\] ordinal scale level 3 or 4). Approximately 300 participants will be enrolled and randomized 2:1 to the Investigational arm or the Control arm. The study will be divided into the following periods: Screening period: (up to 2 days), Intervention (up to 10 days), follow-up (Day 14 and Day 28).

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	RESP301, a Nitric Oxide generating solution	Product application requires inhalation using a standard handheld nebulizer.
OTHER	Standard of Care	Participants will receive institutional SOC for the treatment of COVID-19.

Timeline

• Start date: 2020-07-29
• Primary completion: 2021-04-24
• Completion: 2021-05-21
• First posted: 2020-07-07
• Last updated: 2022-06-02
• Results posted: 2022-06-02

Locations

2 sites across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study