NCT04842331

PREvent Viral Exposure and Transmission Study: a COVID-19 (SARS-CoV-2) PEP Study (PREVENT)

A Randomised Multicentre Post-exposure Prophylaxis Clinical Trial Evaluating RESP301, an Inhaled Therapy for Treatment of Lung Infections, for Prevention of Onward Transmission of Viral Infections Including SARS-CoV-2 to Household Members

• Status: Withdrawn
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Thirty Respiratory Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

In this study, RESP301 is investigated as a post-exposure prophylaxis (PEP). RESP301 is a liquid which is inhaled using a handheld nebuliser and produces Nitric Oxide, which is also naturally produced in the human body and is a key part of our defence against infections in the lungs. In a laboratory setting,RESP301 has been shown to be highly effective against many respiratory viruses, including CoV2 and influenza. RESP301 is currently being used as treatment for hospitalised COVID-19 patients in an ongoing clinical trial. The aim of this PEP study is to prevent onward transmission of the infection within households by treating both the infected individual and their household members. The primary endpoint is to evaluate the incidence of newly confirmed CoV2 infection (PCR positive) in previously uninfected household members (PCR negative, antibody negative and unvaccinated) of CoV-2 positive index cases after a 7 day course of treatment. Participants who are not eligible to participate, or do not want to participate will be invited to take part in an optional study where the participants will be asked to complete a short questionnaire. Participants will be on the study for a total duration of 15-17 days. Approximately 600 adults will be on the study in total and index cases will be randomised 1:1 to either RESP301 (plus SOC) or SOC alone, with all eligible persons in the same household enrolled into the same treatment arm. The study will be divided into the following periods: Baseline Visit / screening (1 day): Treatment Period (self administered at home - 7 days): End of Treatment Period (1 day): Follow-Up Period (\~5-7 days): Follow-Up Call (1 day between day 15-17)

Conditions

• Respiratory Viral Infection
• Respiratory Tract Diseases
• COVID-19 Respiratory Infection

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-09-01
• Primary completion: 2022-01-01
• Completion: 2022-01-01
• First posted: 2021-04-13
• Last updated: 2024-01-12

Locations

1 site across 1 country: United Kingdom