Trials Sponsors Conditions Drugs Pricing

Conditions

COVID-19 Respiratory Infection Respiratory Tract Diseases Respiratory Viral 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)

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age ≥18 years of age
Able to give written informed consent

Sponsors & Collaborators

Thirty Respiratory Limited
Industrylead

Study Sites (1)

Imperial College Healthcare NHS Trust

London, W2 1NY, United Kingdom

MeSH Terms

Conditions

Respiratory Tract Diseases

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

Onn Min Kon, Professor
Imperial College Healthcare NHS Trust
PRINCIPAL INVESTIGATOR

Enrollment

0 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2 3
Allocation: RANDOMIZED
Masking: NONE
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 12, 2021

First Posted

April 13, 2021

Study Start

September 2021

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

RESP301 + Standard of Care (SOC)

Standard of Care (SOC)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

RESP301 + Standard of Care (SOC)

Standard of Care (SOC)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations