Nitric Oxide for COVID-19

(NoCovid Trial)

Recruiting at 2 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Massachusetts General Hospital

Disqualifiers: Tracheostomy, High flow nasal cannula, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 3 days

70 Participants Needed

Trial Summary

What is the purpose of this trial?

The scientific community is in search for novel therapies that can help to face the ongoing epidemics of novel Coronavirus (SARS-Cov-2) originated in China in December 2019. At present, there are no proven interventions to prevent progression of the disease. Some preliminary data on SARS pneumonia suggest that inhaled Nitric Oxide (NO) could have beneficial effects on SARS-CoV-2 due to the genomic similarities between this two coronaviruses. In this study we will test whether inhaled NO therapy prevents progression in patients with mild to moderate COVID-19 disease.

Research Team

Lorenzo Berra, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

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.

Inclusion Criteria

You have tested positive for COVID-19 through a lab test or have antibodies for the virus.

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

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

Exclusion Criteria

I was hospitalized for reasons other than COVID-19.

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

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive inhaled Nitric Oxide therapy to prevent progression of mild to moderate COVID-19

3 days

Daily visits (inpatient or outpatient)

Follow-up

Participants are monitored for safety and effectiveness after treatment

28 days

Treatment Details

Interventions

• Nitric Oxide

Trial Overview 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.

Participant Groups

Group I: Nitric Oxide inhalation Experimental Treatment 1 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 Treatment 1 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: Control Active Control 1 Intervention

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

Nitric Oxide is already approved in United States for the following indications:

Approved in United States as Inomax for:

• Hypoxic respiratory failure in term and near-term neonates with pulmonary hypertension

Approved in United States as Noxivent for:

• Hypoxic respiratory failure in term and near-term neonates with pulmonary hypertension

Approved in United States as GeNOsyl for:

• Hypoxic respiratory failure in term and near-term neonates with pulmonary hypertension

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

University of Alabama at Birmingham

Collaborator

Trials

1,677

Recruited

2,458,000+