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PREvent Viral Exposure aNd Transmission Study: a SARS-CoV-2 PEP Study (PREVENT) (PREVENT)

Primary Purpose

Respiratory Viral Infections, in Particular SARS-CoV-2, for Prevention of Onward Transmission, Respiratory Tract Diseases

Status
Unknown status
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
RESP301, a Nitric Oxide generating solution
Sponsored by
Thirty Respiratory Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Respiratory Viral Infections, in Particular SARS-CoV-2, for Prevention of Onward Transmission

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Imperial College Healthcare NHS TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

RESP301 + Standard of Care (SOC)

Standard of Care (SOC)

Arm Description

Outcomes

Primary Outcome Measures

Original Primary Outcome
Evaluate the incidence of newly confirmed CoV-2 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.

Secondary Outcome Measures

Original Secondary Outcome
% 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
Original Secondary Outcome
Compliance with RESP301 administration schedule by enrolled participants over the treatment period (% of total doses taken).

Full Information

First Posted
April 12, 2021
Last Updated
April 12, 2021
Sponsor
Thirty Respiratory Limited
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1. Study Identification

Unique Protocol Identification Number
NCT04842331
Brief Title
PREvent Viral Exposure aNd Transmission Study: a SARS-CoV-2 PEP Study (PREVENT)
Acronym
PREVENT
Official 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.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 2021 (Anticipated)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
January 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thirty Respiratory Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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, 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 who are not eligible to participate, or do not want to participate will be invited to participate in an optional study where they 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Viral Infections, in Particular SARS-CoV-2, for Prevention of Onward Transmission, Respiratory Tract Diseases

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Patients are randomised to 1 of 2 arms.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RESP301 + Standard of Care (SOC)
Arm Type
Experimental
Arm Title
Standard of Care (SOC)
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
RESP301, a Nitric Oxide generating solution
Other Intervention Name(s)
Standard of Care (SOC)
Intervention Description
Participants will receive institutional SOC for the treatment
Primary Outcome Measure Information:
Title
Original Primary Outcome
Description
Evaluate the incidence of newly confirmed CoV-2 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.
Time Frame
Day 1-7
Secondary Outcome Measure Information:
Title
Original Secondary Outcome
Description
% 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
Time Frame
Day 1
Title
Original Secondary Outcome
Description
Compliance with RESP301 administration schedule by enrolled participants over the treatment period (% of total doses taken).
Time Frame
Day 1-7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alison Bracchi, Msc
Phone
+44 (0)1235 431 200
Email
alison.bracchi@30.technology
First Name & Middle Initial & Last Name or Official Title & Degree
Marijana Flego
Phone
+44 (0)1235 431 200
Email
marijana.flego@30.technology
Facility Information:
Facility Name
Imperial College Healthcare NHS Trust
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Onn M Kon
Phone
02078861344
Email
onn.kon@nhs.net

12. IPD Sharing Statement

Learn more about this trial

PREvent Viral Exposure aNd Transmission Study: a SARS-CoV-2 PEP Study (PREVENT)

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