A Study to Assess Efficacy and Safety of RESP301 Plus Standard of Care (SOC) Compared to SOC Alone in Hospitalized Participants With COVID-19

NCT ID: NCT04460183

Last Updated: 2022-06-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-29
• Study Completion Date: 2021-05-21

Brief Summary

The effect of RESP301 as an add on treatment to SOC will be evaluated for its efficacy in reducing rate of progression to a more severe level of COVID-19 and for safety, by comparison with SOC alone in hospitalized COVID-19 patients.

Detailed Description

This is an open-label, randomized, multicenter, parallel group, concurrent, controlled study using a sequential adaptive design to evaluate the efficacy and safety of RESP301 plus SOC versus SOC alone in hospitalized patients with COVID-19 (World Health Organization [WHO] ordinal scale level 3 or 4).

Approximately 300 participants will be enrolled and randomized 2:1 to the Investigational arm or the Control arm. The study will be divided into the following periods: Screening period: (up to 2 days), Intervention (up to 10 days), follow-up (Day 14 and Day 28).

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Investigational arm

Participants will receive inhaled RESP301 administered using a nebulizer three times a day for up to 10 days in addition to the standard of care.

Group Type: EXPERIMENTAL

RESP301, a Nitric Oxide generating solution

Intervention Type: DRUG

Product application requires inhalation using a standard handheld nebulizer.

Standard of Care

Intervention Type: OTHER

Participants will receive institutional SOC for the treatment of COVID-19.

Control arm

Participants will receive institutional SOC for the treatment of COVID-19

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: OTHER

Participants will receive institutional SOC for the treatment of COVID-19.

Interventions

RESP301, a Nitric Oxide generating solution

Product application requires inhalation using a standard handheld nebulizer.

Intervention Type: DRUG

Standard of Care

Participants will receive institutional SOC for the treatment of COVID-19.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Participant has laboratory-confirmed SARS-CoV-2 infection as determined by reverse transcriptase polymerase chain reaction (RT-PCR) or other approved clinical testing prior to randomization.

2. Participant is hospitalized in relation to COVID-19, requiring supplemental oxygen to maintain SpO2 at a safe level (WHO level 3 & 4).

3. Participant is capable of giving signed informed consent

4. Participant is male or female. All females of childbearing potential, including pregnant females, must consent to urine pregnancy testing at screening to be eligible for the study.

Exclusion Criteria

1. Rapidly deteriorating or likely to require escalation to high flow oxygen, invasive or non-invasive ventilatory support within 24 hours according to Investigator's opinion.

2. Unable to safely receive a nebulized treatment for approximately 8 minutes according to Investigator's opinion.

3. Unable to receive or considered ineligible for invasive or non-invasive ventilatory support.

4. History of methemoglobinemia.

5. Presence of uncontrolled asthma, history of severe bronchospasm.

6. Presence of severe chronic respiratory disease and tracheostomy.

7. Suspected or confirmed untreated, active tuberculosis.

8. Severely immune-compromised participants in Investigator's opinion.

9. Recent active coronary artery disease or decompensated heart failure.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Thirty Respiratory Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Imperial College Healthcare NHS Trust, St. Mary's Hospital

London, , United Kingdom

Royal Preston Hospital

Preston, , United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

RESP301-002

Identifier Type: -

Identifier Source: org_study_id