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COMPLETED Phase 2

Nitric Oxide Gas Inhalation in Severe Acute Respiratory Syndrome in COVID-19

NCT04306393 · View on ClinicalTrials.gov ↗

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

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

FieldValue
Enrollment Target 200 participants
Start Date 2020-03-21
Est. Completion 2022-06-15
Phase Phase 2

Sponsor

Massachusetts General Hospital

1,948 total trials

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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 1,948 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04306393 reports 5 study locations spanning 4 distinct geographic areas — top geographies include Massachusetts, Alabama, Louisiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04306393?

The interventions under investigation include: Nitric Oxide Gas (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04306393?

This trial is sponsored by Massachusetts General Hospital, which has 1,948 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial