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 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2022-06-02

Study results available
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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

Interventions

DRUG

RESP301, a Nitric Oxide generating solution

Product application requires inhalation using a standard handheld nebulizer.

OTHER

Standard of Care

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

Sponsors & Collaborators

  • Thirty Respiratory Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-29
Primary Completion
2021-04-24
Completion
2021-05-21
FDA Drug
Yes

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04460183 on ClinicalTrials.gov