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NCT04306393 · ClinicalTrials.gov registry record · Phase 2
Nitric Oxide Gas Inhalation in Severe Acute Respiratory Syndrome in COVID-19
A Phase 2 study of Coronavirus and SARS (Severe Acute Respiratory Syndrome), sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 200
- Enrollment target
- 5
- Study locations
NCT04306393 is a Phase 2 study of Coronavirus and SARS (Severe Acute Respiratory Syndrome) that has completed, run by Massachusetts General Hospital. The registered enrollment target is 200 participants, below the 1,395-participant average among 20 other Coronavirus trials with a reported enrollment target (86% lower). The trial reports 5 study locations across 4 states.
The verdict
NCT04306393, a Phase 2 study of Coronavirus and SARS (Severe Acute Respiratory Syndrome), has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 200 participants
- Enrollment target
- 5
- Study locations
Study Summary
Severe acute respiratory syndrome (SARS-CoV2) due to novel Coronavirus (2019-nCoV) related infection (COVID-19) is characterized by severe ventilation perfusion mismatch leading to refractory hypoxemia. To date, there is no specific treatment available for 2019-nCoV. Nitric oxide is a selective pulmonary vasodilator gas used in as a rescue therapy in refractory hypoxemia due to acute respiratory distress syndrome (ARDS). In-vitro and clinical evidence indicate that inhaled nitric oxide gas (iNO) has also antiviral activity against other strains of coronavirus. The primary aim of this study is to determine whether inhaled NO improves oxygenation in patients with hypoxic SARS-CoV2. This is a multicenter single-blinded randomized controlled trial with 1:1 individual allocation
Conditions Studied
Interventions
- DRUG Nitric Oxide Gas
Study Locations (5)
Massachusetts
- Massachusetts General Hospital - Boston
- Beth Israel Deaconess Medical Center - Boston
Alabama
- University of Alabama - Birmingham
Louisiana
- Louisiana State University Health Shreveport - Shreveport
Stockholm County
- Danderyd Sjukhus AB - Danderyd
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2020-03-21 |
| Est. Completion | 2022-06-15 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04306393
The ClinicalTrials.gov registry entry for NCT04306393 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,395-participant average among 20 other Coronavirus trials with a reported enrollment target (86% lower). The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Coronavirus appearing as the primary indexed condition, and to 1 intervention - of which Nitric Oxide Gas is the first listed.
NCT04306393 reports 5 study locations spanning 4 distinct geographic areas - top geographies include Massachusetts, Alabama, Louisiana.
Frequently Asked Questions
What is clinical trial NCT04306393 about?
NCT04306393 is a clinical study titled "Nitric Oxide Gas Inhalation in Severe Acute Respiratory Syndrome in COVID-19". Severe acute respiratory syndrome (SARS-CoV2) due to novel Coronavirus (2019-nCoV) related infection (COVID-19) is characterized by severe ventilation perfusion mismatch leading to refractory hypoxemia. To date, there is no specific treatment available for 2019-nCoV. Nitric oxide is a selective pulm...
What is the current status of trial NCT04306393?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 200 participants. The study started on 2020-03-21. Estimated completion is 2022-06-15.
What conditions does trial NCT04306393 study?
This clinical trial studies the following conditions: Coronavirus, SARS (Severe Acute Respiratory Syndrome).
What interventions are being tested in trial NCT04306393?
The interventions under investigation include: Nitric Oxide Gas (DRUG).
Who is sponsoring clinical trial NCT04306393?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04306393 being conducted?
This trial has 5 study locations across Alabama, Louisiana, Massachusetts, Stockholm County. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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