At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 19 enrolled
Drug / intervention
RESP301, a Nitric Oxide generating solution +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating RESP301, a Nitric Oxide generating solution and Standard of Care for COVID-19. Completed, enrolled 19 participants across 2 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOVID-19
CountriesUnited Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
202120222023202420252026
First PostedJul 2020
Enrollment StartJul 2020
Primary CompletionApr 2021
Study CompletionMay 2021
TodayJul 2026
First PostedJul 7, 2020
Enrollment StartJul 29, 2020
Primary CompletionApr 24, 2021
Study CompletionMay 21, 2021
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 6.0 years ago
Interventions
RESP301, a Nitric Oxide generating solutiondrug
Product application requires inhalation using a standard handheld nebulizer.
Standard of Careother
Participants will receive institutional SOC for the treatment of COVID-19.