A Study to Assess Efficacy and Safety of RESP301 Plus Standard of Care (SOC) Compared to SOC Alone in Hospitalized Participants With COVID-19
NCT04460183 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 19
Last updated 2022-06-02
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.
Conditions
Interventions
- 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.
Sponsors & Collaborators
-
Thirty Respiratory Limited
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-07-29
- Primary Completion
- 2021-04-24
- Completion
- 2021-05-21
- FDA Drug
- Yes
Countries
- United Kingdom
Study Locations
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