Phase 3
N=19
A Study to Assess Efficacy and Safety of RESP301 Plus Standard of Care (SOC) Compared to SOC Alone in Hospitalized Participants With COVID-19
COVID-19
Bottom Line
View on ClinicalTrials.gov: NCT04460183 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Jun 2022
Primary outcome: Primary: Number of Participants Who Progress by at Least One Level Higher on the Modified WHO Ordinal Scale — 0; 0; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- RESP301, a Nitric Oxide generating solution (Drug); Standard of Care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Thirty Respiratory Limited
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Progress by at Least One Level Higher on the Modified WHO Ordinal Scale |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Change in Room Air Oxygen Saturation (SpO2) From Baseline Over Time |
0.1; NA; -1.7; 1.5; 0.9; 3.3 | — |
| SECONDARY Change in National Early Warning Score (NEWS) 2 Symptom Score From Baseline Over Time |
-0.8; 1.4; -1.3; -0.2; 1.0; 0.5 | — |
| SECONDARY Change From Baseline for Number of Participants on the Modified WHO Ordinal Scale at Each Visit |
0; 0; 0; 0; 4; 0 | — |
| SECONDARY Time to Improvement of at Least One Level Lower on the Modified WHO Ordinal Scale |
4.00; 5.00 | — |
| SECONDARY Time to Progression of at Least One Level Higher on the Modified WHO Ordinal Scale |
NA | — |
| SECONDARY Number of Participants With Adverse Events |
10; 2; 1; 0; 3; 0 | — |
| SECONDARY Time to Hospital Discharge |
4.00; 6.00 | — |
| SECONDARY Number of Participants With Mortality by Day 28 |
0; 0 | — |
| SECONDARY Reduction in Oxygen Saturation (SpO2) to <90% |
95.0; 93.5; 94.0; 86.0; 96.0; 94.0 | — |
| SECONDARY Events of Clinical Bronchial Hyper Responsiveness Related to Nebulization |
2; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04460183). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.