PREvent Viral Exposure aNd Transmission study: a SARS-CoV-2 PEP Study [COVID-19]
Research type
Research Study
Full title
A randomised, multicentre post-exposure prophylaxis (PEP) 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.
IRAS ID
293815
Contact name
Alison Bracchi
Contact email
Sponsor organisation
Thirty Respiratory Ltd
Eudract number
2021-000128-37
Clinicaltrials.gov Identifier
U1111-1263-5201, UTN Number
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
The global COVID-19 pandemic caused by the highly contagious SARS-CoV-2 (CoV2) virus is a major public health concern. In Dec 2020 the virus was isolated with up to 70% greater rate of transmission resulting in a large increase in the number of infected cases. While the vaccination program underway offers hope, there are concerns that new variants (e.g. South Africa) may show resistance to vaccinations.
An urgent medical need exists to reduce transmission and protect the general population.
In this study, we are investigating RESP301 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 will be on the study for a total duration of 15-17 days. Approximately 600 adults will be on the study in total, with 300 on treatment and Standard of care (SOC) and 300 on SOC only. Study treatment will be for 7 days, which will be self-administered at home after the Baseline Visit dose has been administered under clinical supervision either at home or in the clinic (a total of 21 doses).
REC name
London - Fulham Research Ethics Committee
REC reference
20/HRA/6338
Date of REC Opinion
29 Jan 2021
REC opinion
Further Information Favourable Opinion