Respiratory Viral InfectionPhase 2/3PREVENTNCT04842331
PREvent Viral Exposure and Transmission Study: a COVID-19 (SARS-CoV-2) PEP Study (PREVENT)
A Phase 2/3 study testing RESP301 (a nitric oxide generating solution) in people with Respiratory Viral Infection and Respiratory Tract Diseases, run by Thirty Respiratory Limited at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Viral Infection, Respiratory Tract Diseases, COVID-19 Respiratory Infection
- What is being tested?
- RESP301 (a nitric oxide generating solution)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2021to Jan 2022
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Imperial College Healthcare NHS Trust
London, W2 1NY
About this study
Official 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
This is an open label controlled household-randomised trial designed to evaluate the efficacy of RESP301 alongside standard of care ("SOC") versus SOC alone.
Read the 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)
- Being tested
- RESP301 (a nitric oxide generating solution), Standard of Care (SOC)
- Medical subject headings
- Respiratory Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RESP301 (a nitric oxide generating solution)Drug
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.
Standard of Care (SOC)Drug
Participants will receive institutional SOC for the treatment.
| Study group | Role | What they receive |
|---|---|---|
| RESP301 + Standard of Care (SOC) | Experimental | Treatment arm will receive the study drug RESP301 alongside standard of care (SOC).
RESP301 will be administered for a period of 7 days (i.e. 21 doses) to both index cases and their household members in the treatment arm. Participants will be given the first dose under medical supervision and self-administer at home the remaining 20 doses.
RESP301 is a formulation consisting of 3 agents currently used in clinical practice: mannitol, sodium nitrite and citric acid. Receives: Drug: RESP301 (a nitric oxide generating solution); Drug: Standard of Care (SOC) |
| Standard of Care (SOC) | Active comparator | SOC Receives: Drug: Standard of Care (SOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1-7
Secondary outcomes (2)
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
Measured: Day 1
Percentage (%) of total doses taken
Compliance with RESP301 administration schedule by enrolled participants over the treatment period (% of total doses taken).
Measured: Day 1-7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2021
- Study startSep 2021 (estimated)
- Primary completionJan 2022 (estimated)
- Study completionJan 2022 (estimated)
Why it stopped: A combination of factors, including the dynamic nature of the COVID-19 pandemic and the successful vaccination program, has resulted in a very sharp decline in the number of patients with COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Viral InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients are randomised to 1 of 2 arms.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thirty Respiratory Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Onn Min Kon, Professor, Principal investigator, Imperial College Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04842331
- Sponsor's protocol ID
- RESP301-006
- Acronym
- PREVENT
- Status last verified
- Jan 2024
- First submitted
- 12 Apr 2021
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04842331
- Acronym / sponsor ID
- PREVENT / RESP301-006
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: A combination of factors, including the dynamic nature of the COVID-19 pandemic and the successful vaccination program, has resulted in a very sharp decline in the number of patients with COVID-19
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Thirty Respiratory LimitedIndustry (pharma, biotech, devices)
- Study start
- Sep 2021 (estimated)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 13 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients are randomised to 1 of 2 arms.
| Arm | Type | Receives |
|---|---|---|
| RESP301 + Standard of Care (SOC) | Experimental | Drug: RESP301 (a nitric oxide generating solution), Drug: Standard of Care (SOC)Treatment arm will receive the study drug RESP301 alongside standard of care (SOC). RESP301 will be administered for a period of 7 days (i.e. 21 doses) to both index cases and their household members in the treatment arm. Participants will be given the first dose under medical supervision and self-administer at home the remaining 20 doses. RESP301 is a formulation consisting of 3 agents currently used in clinical practice: mannitol, sodium nitrite and citric acid. |
| Standard of Care (SOC) | Active comparator | Drug: Standard of Care (SOC)SOC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | RESP301 + Standard of Care (SOC) |
| Standard of Care (SOC)Participants will receive institutional SOC for the treatment. | Drug | RESP301 + Standard of Care (SOC), Standard of Care (SOC) |
Primary outcome
PCR positive and negative
Time frame: Day 1-7
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.
2 secondary outcomes
Percentage (%) of participants able to tolerate the test dose
Time frame: Day 1
Percentage (%) of total doses taken
Time frame: Day 1-7
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Onn Min Kon, Professor principal investigator
Imperial College Healthcare NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing RESP301 (a nitric oxide generating solution) in people with Respiratory Viral Infection and Respiratory Tract Diseases, run by Thirty Respiratory Limited at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PCR positive and negative (time frame: Day 1-7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2024.