Clinical trial NCT04460183: A Study to Assess Efficacy and Safety of RESP301 Plus Standard of Care (SOC) Compared to SOC Alone in Hospitalized Participants With COVID-19
Official title: An Open-label, Adaptive Randomized, Controlled Multicenter Study to Evaluate the Efficacy and Safety of RESP301 Plus Standard of Care (SOC) Compared to SOC Alone in Hospitalized Participants With COVID-19 WHO Grade 3&4 (NOCoV2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: COVID-19
Lead sponsor: Thirty Respiratory Limited
Sponsor class: INDUSTRY
First posted: 2020-07-07
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Number of Participants Who Progress by at Least One Level Higher on the Modified WHO Ordinal Scale
timeFrame: Baseline, Day 2 and Day 3
Secondary outcomes:
measure: Change in Room Air Oxygen Saturation (SpO2) From Baseline Over Time
timeFrame: Day 1 (Baseline) Post-Nebulization, Day 2, 3, 4, 5, 6, and 7
measure: Change in National Early Warning Score (NEWS) 2 Symptom Score From Baseline Over Time
timeFrame: Day 1 (Baseline), Day 2, 3, 4, 5, 6, and 7
measure: Change From Baseline for Number of Participants on the Modified WHO Ordinal Scale at Each Visit
timeFrame: Day 1 (Baseline), Day 2, 3, 4, 5, 6, and 7
measure: Time to Improvement of at Least One Level Lower on the Modified WHO Ordinal Scale
timeFrame: From Baseline to Day 28
measure: Time to Progression of at Least One Level Higher on the Modified WHO Ordinal Scale
timeFrame: From Baseline to Day 28
measure: Number of Participants With Adverse Events
timeFrame: From screening to safety follow up (Day 28)
measure: Time to Hospital Discharge
timeFrame: Day 10
measure: Number of Participants With Mortality by Day 28
timeFrame: Day 28
measure: Reduction in Oxygen Saturation (SpO2) to <90%
timeFrame: Day 1 (Baseline), Day 2, Day 3
measure: Events of Clinical Bronchial Hyper Responsiveness Related to Nebulization
timeFrame: From screening to safety follow up (Day 28)
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust, St. Mary's Hospital
city: Preston
country: United Kingdom
facility: Royal Preston Hospital
Study officials:
References: