Status:
WITHDRAWN
PREvent Viral Exposure and Transmission Study: a COVID-19 (SARS-CoV-2) PEP Study (PREVENT)
Lead Sponsor:
Thirty Respiratory Limited
Conditions:
Respiratory Viral Infection
Respiratory Tract Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- Age ≥18 years of age
- Able to give written informed consent
- Index cases: presenting with mild/moderate viral infection symptoms, who the Investigator considers can be treated at home.
- Negative pregnancy test for women of childbearing age at Baseline visit (includes screening).
- Able to operate and maintain nebuliser, as assessed by the Investigator.
Exclusion
- Both Index cases and Household members: Unable to tolerate use of a nebuliser for approximately 8-10 minutes as required by the study according to Investigator's opinion
- Both Index and Household members:
- Any unstable, uncontrolled or severe medical condition which in the opinion of the investigator would make the participant unsuitable for the trial
- COPD/Asthma or any severe respiratory disease requiring the use of oral steroids or biologics
- Participation in other clinical investigations utilising investigational treatment within the last 30 days / 5 half-lives whichever is longer
- Participant lives at home with no other potentially eligible adults in the household
- Women of childbearing age unable or unwilling to use an adequate form of contraception for the duration of the study i.e. double barrier contraceptives.
- Male participants who are unwilling or unable to use an effective method of contraception for the duration of the study.
- Known allergy/hypersensitivity to or relevant drug-drug interaction with study drug/components of study drug
- History of methaemoglobinaemia
- Deemed unlikely to be able to adhere to protocol in view of investigator
- Any subject who in the opinion of the investigator would not be best served by participating in this clinical trial
- Prescribed Nitric Oxide donating agents (e.g. Nitroprusside, Isosorbide dinitrate, Isosorbide mononitrate, Naproxcinod, Molsidomine and Linsidomine)
Key Trial Info
Start Date :
September 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04842331
Start Date
September 1 2021
End Date
January 1 2022
Last Update
January 12 2024
Active Locations (1)
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1
Imperial College Healthcare NHS Trust
London, United Kingdom, W2 1NY