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

• Status: Withdrawn
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The investigators will enroll 102 patients with a confirmed diagnosis of COVID-19. Patients will be randomized to receive either inhaled nitric oxide (per protocol) or 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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xijing Hospital
• Collaborators: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico; Massachusetts General Hospital
• Treatments: Nitric Oxide

Criteria

Inclusion Criteria:

1. Age ≥18 years

2. Laboratory (RT-PCR) confirmed infection with 2019-nCoV

3. PaO2/FiO2 < 300 or SpO2 below 93% breathing ambient air

Exclusion Criteria:

1. Physician makes a decision that trial involvement is not in the patient's best interest, or any condition that does not allow the protocol to be followed safely

2. Pregnant or positive pregnancy test in a pre-dose examination

3. Use of high flow nasal cannula