PREvent Viral Exposure and Transmission Study: a COVID-19 (SARS-CoV-2) PEP Study (PREVENT)

NCT04842331 | Withdrawn Phase 2 DMC

• 1 other identifier: RESP301-006
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Viral Infection; Respiratory Tract Diseases; COVID-19 Respiratory Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Percentage (%) of participants able to tolerate the test dose

  Day 1

• Percentage (%) of total doses taken

  Day 1-7

Study Arms (2)

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.

Drug: RESP301 (a nitric oxide generating solution); Drug: Standard of Care (SOC)

Standard of Care (SOC)

ACTIVE COMPARATOR

SOC

Drug: Standard of Care (SOC)

Interventions

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.

RESP301 + Standard of Care (SOC)

Standard of Care (SOC) DRUG

Participants will receive institutional SOC for the treatment.

RESP301 + Standard of Care (SOC); Standard of Care (SOC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Thirty Respiratory Limited: lead

Study Sites (1)

Imperial College Healthcare NHS Trust

London, W2 1NY, United Kingdom

Location

MeSH Terms

Conditions

Respiratory Tract Diseases

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Onn Min Kon, Professor

  Imperial College Healthcare NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients are randomised to 1 of 2 arms.

Study Record Dates

• First Submitted: April 12, 2021
• First Posted: April 13, 2021
• Study Start: September 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: January 12, 2024

Record last verified: 2024-01

Locations

GB (1)