COVID-19 Respiratory Infection Clinical Trial
— PREVENTOfficial title:
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
| Verified date | January 2024 |
| Source | Thirty Respiratory Limited |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This is an open label controlled household-randomised trial designed to evaluate the efficacy of RESP301 alongside standard of care ("SOC") versus SOC alone.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | January 2022 |
| Est. primary completion date | January 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: 1. Age =18 years of age 2. Able to give written informed consent 3. Index cases: presenting with mild/moderate viral infection symptoms, who the Investigator considers can be treated at home. 4. Negative pregnancy test for women of childbearing age at Baseline visit (includes screening). 5. Able to operate and maintain nebuliser, as assessed by the Investigator. Exclusion Criteria: 1. 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 2. Both Index and Household members: 1. Any unstable, uncontrolled or severe medical condition which in the opinion of the investigator would make the participant unsuitable for the trial 2. COPD/Asthma or any severe respiratory disease requiring the use of oral steroids or biologics 3. Participation in other clinical investigations utilising investigational treatment within the last 30 days / 5 half-lives whichever is longer 4. Participant lives at home with no other potentially eligible adults in the household 5. 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. 6. Male participants who are unwilling or unable to use an effective method of contraception for the duration of the study. 7. Known allergy/hypersensitivity to or relevant drug-drug interaction with study drug/components of study drug 8. History of methaemoglobinaemia 9. Deemed unlikely to be able to adhere to protocol in view of investigator 10. Any subject who in the opinion of the investigator would not be best served by participating in this clinical trial 11. Prescribed Nitric Oxide donating agents (e.g. Nitroprusside, Isosorbide dinitrate, Isosorbide mononitrate, Naproxcinod, Molsidomine and Linsidomine) |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Imperial College Healthcare NHS Trust | London |
| Lead Sponsor | Collaborator |
|---|---|
| Thirty Respiratory Limited |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | PCR positive and negative | PCR positive cases in previously uninfected household members (PCR negative, antibody negative and unvaccinated) of CoV-2 positive index cases after a 7 day course of treatment. | Day 1-7 | |
| Secondary | Percentage (%) of participants able to tolerate the test dose | Percentage (%) of participants able to tolerate the test dose, i.e. without any treatment-related AE at the Baseline Visit that led to participant not being able to continue with the remaining doses | Day 1 | |
| Secondary | Percentage (%) of total doses taken | Compliance with RESP301 administration schedule by enrolled participants over the treatment period (% of total doses taken). | Day 1-7 |