← Back to Search

Gas

Nitric Oxide for COVID-19 (NoCovid Trial)

Phase 2

Waitlist Available

Led By Lorenzo Berra, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Spontaneous breathing with or without hypoxia of any degree. Gas exchange and ventilation maybe assisted by any continuous airway pressure (CPAP), or any system of Non Invasive Ventilation (NIV), with Positive End-Expiratory Pressure (PEEP) ≤ 10 cmH2O

Hospital admission with at least one of the following: fever ≥ 36.6 °C from axillary site, or ≥ 37.2°C from oral site, or ≥ 37.6°C from tympanic or rectal site

Must not have

Primary cause of hospitalization not due to COVID-19

Therapy with high flow nasal cannula

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 28 days

Awards & highlights

No Placebo-Only Group

All Individual Drugs Already Approved

Summary

This trial will test whether inhaled nitric oxide therapy can prevent the progression of COVID-19 in patients with mild to moderate symptoms.

Who is the study for?

This trial is for people with confirmed COVID-19 showing mild to moderate symptoms like fever, cough, or breathing difficulties but not severe enough to require high-flow oxygen or intubation. They must be newly hospitalized and not part of another study. Those with tracheostomies, on certain oxygen therapies, or with other health issues that the doctor thinks could interfere are excluded.

What is being tested?

The trial is testing if inhaling Nitric Oxide (NO) gas can stop the worsening of COVID-19 in patients. NO has shown promise against similar viruses in the past. Participants will breathe in NO through a mask or tube to see if it helps improve their lung function and prevents severe disease progression.

What are the potential side effects?

Inhaling Nitric Oxide may cause side effects such as headache, dizziness, nausea, or increased bleeding risk. It might also lead to low blood pressure when standing up too quickly after sitting or lying down.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can breathe on my own, even if I need some assistance.

Select...

I was admitted to the hospital with a fever measured from underarm, mouth, ear, or rectum.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I was hospitalized for reasons other than COVID-19.

Select...

I am currently using a high flow nasal cannula for breathing support.

Select...

I have been in the hospital with COVID-19 for over 72 hours.

Select...

I need oxygen at home for my lung condition.

Select...

I have a tracheostomy.

Select...

I was previously on a ventilator for COVID-19.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~28 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Reduction in the incidence of patients with mild/moderate COVID-19 requiring intubation and mechanical ventilation

Secondary study objectives

Mortality

Time to clinical recovery

Other study objectives

Negative conversion of COVID-19 RT-PCR from upper respiratory tract

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Nitric Oxide inhalationExperimental Treatment1 Intervention

Nitric Oxide will be delivered through a non invasive CPAP system (with minimal pressure support to decrease discomfort due to the facial mask) or through a non-rebreathing mask system.

Group II: Nitric Oxide Inhalation (Non-Randomized)Experimental Treatment1 Intervention

All subjects part of this arm will receive nitric oxide gas either as an inpatient or outpatient. Nitric Oxide will be delivered through a non invasive CPAP system (with minimal pressure support to decrease discomfort due to the facial mask) or through a non-rebreathing mask system. Patients in this arm will not be randomized, so that all patients receive the study medication.

Group III: ControlActive Control1 Intervention

Patients assigned to the control group will not receive any gas therapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nitric Oxide

FDA approved

0 / 8Eligibility criteria met