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

NCT04460183 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: RESP301-002
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 2

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Progress by at Least One Level Higher on the Modified WHO Ordinal Scale

  A modified WHO ordinal scale was used for consistency with the recent study in adults hospitalized with severe COVID-19, to record the participant's status at the time of assessment. The modified WHO ordinal scale included the following levels : 1= Not hospitalized, no limitations on activities; 2= Not hospitalized, limitation on activities; 3= Hospitalized, not requiring supplemental oxygen; 4= Hospitalized, requiring supplemental oxygen; 5= Hospitalized, on non-invasive ventilation or high-flow oxygen devices; 6= Hospitalized, on invasive mechanical ventilation or extra corporeal membrane oxygenation (ECMO); 7= Death. Higher scores mean worse outcome. The number of participants that had an increase in at least one level higher score on the modified WHO ordinal scale was assessed.

  Baseline, Day 2 and Day 3

Secondary Outcomes (10)

• Change in Room Air Oxygen Saturation (SpO2) From Baseline Over Time

  Day 1 (Baseline) Post-Nebulization, Day 2, 3, 4, 5, 6, and 7

• Change in National Early Warning Score (NEWS) 2 Symptom Score From Baseline Over Time

  Day 1 (Baseline), Day 2, 3, 4, 5, 6, and 7

• Change From Baseline for Number of Participants on the Modified WHO Ordinal Scale at Each Visit

  Day 1 (Baseline), Day 2, 3, 4, 5, 6, and 7

• Time to Improvement of at Least One Level Lower on the Modified WHO Ordinal Scale

  From Baseline to Day 28

• Time to Progression of at Least One Level Higher on the Modified WHO Ordinal Scale

  From Baseline to Day 28

Study Arms (2)

Investigational arm

EXPERIMENTAL

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.

Drug: RESP301, a Nitric Oxide generating solution; Other: Standard of Care

Control arm

ACTIVE COMPARATOR

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

Other: Standard of Care

Interventions

RESP301, a Nitric Oxide generating solution DRUG

Product application requires inhalation using a standard handheld nebulizer.

Investigational arm

Standard of Care OTHER

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

Control arm; Investigational arm

Eligibility Criteria

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

You may qualify if:

• 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.
• Participant is hospitalized in relation to COVID-19, requiring supplemental oxygen to maintain SpO2 at a safe level (WHO level 3 \& 4).
• Participant is capable of giving signed informed consent
• 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.

You may not qualify if:

• 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.
• Unable to safely receive a nebulized treatment for approximately 8 minutes according to Investigator's opinion.
• Unable to receive or considered ineligible for invasive or non-invasive ventilatory support.
• History of methemoglobinemia.
• Presence of uncontrolled asthma, history of severe bronchospasm.
• Presence of severe chronic respiratory disease and tracheostomy.
• Suspected or confirmed untreated, active tuberculosis.
• Severely immune-compromised participants in Investigator's opinion.
• Recent active coronary artery disease or decompensated heart failure.

Sponsors & Collaborators

• Thirty Respiratory Limited: lead

Study Sites (2)

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

London, W2 1NY, United Kingdom

Location

Royal Preston Hospital

Preston, PR2 9HT, United Kingdom

Location

MeSH Terms

Conditions

COVID-19

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Alison Bracchi, MSc
• Organization: Thirty Respiratory Ltd

alison.bracchi@30.technology

+447763882519

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: July 3, 2020
• First Posted: July 7, 2020
• Study Start: July 29, 2020
• Primary Completion: April 24, 2021
• Study Completion: May 21, 2021
• Last Updated: June 2, 2022
• Results First Posted: June 2, 2022

Record last verified: 2022-04

Locations

GB (2)