PREvent Viral Exposure and Transmission Study: a COVID-19 (SARS-CoV-2) PEP Study (PREVENT)
NCT04842331 · Status: WITHDRAWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL
Last updated 2024-01-12
Summary
This is an open label controlled household-randomised trial designed to evaluate the efficacy of RESP301 alongside standard of care ("SOC") versus SOC alone.
Conditions
- Respiratory Viral Infection
- Respiratory Tract Diseases
- COVID-19 Respiratory Infection
Interventions
- DRUG
-
RESP301 (a nitric oxide generating solution)
Administration is simple and convenient; each dose of RESP301 is administered 3 times daily (at least 4 hours apart) via inhalation using a portable handheld vibrating mesh nebuliser for approximately 8-10 minutes.
- DRUG
-
Standard of Care (SOC)
Participants will receive institutional SOC for the treatment.
Sponsors & Collaborators
-
Thirty Respiratory Limited
lead INDUSTRY
Principal Investigators
-
Onn Min Kon, Professor · Imperial College Healthcare NHS Trust
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-09-30
- Primary Completion
- 2022-01-31
- Completion
- 2022-01-31
Countries
- United Kingdom
Study Locations
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