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

NCT04290871 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2023-02-08

No results posted yet for this study

Summary

The investigators will enroll 104 patients with severe COVID-19 infection that mechanical ventilation is needed for respiratory support. Patients will be randomized to receive either inhaled nitric oxide (per protocol) or a placebo. ICU Standards of care will be the institution's own protocols (such as ventilation strategies and use and dose of antivirals and antimicrobials, steroids, inotropic and vasopressor agents).

Conditions

  • Coronavirus Covid-19 Infection Variant Omicron
  • SARS (Severe Acute Respiratory Syndrome)

Interventions

DRUG

Nitric Oxide Gas

Inspired NO/N2 will be delivered at 80 parts per million (ppm) in the first 48 hours of enrollment (within 48 hours after initiation of mechanical ventilation). Weaning from NO will start after 48-h consecutive NO inhalation. The physicians will follow their own institutional weaning protocols.

OTHER

The delivery system will be set up anyway without study gas administration

The delivery system will be set up anyway without study gas administration

Sponsors & Collaborators

  • Xijing Hospital

    lead OTHER

Principal Investigators

  • Chong Lei, MD, PhD · Air Force Military Medical University, China

  • Lorenzo Berra, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-16
Primary Completion
2023-12-31
Completion
2024-04-01

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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 NCT04290871 on ClinicalTrials.gov