A new, international clinical trial is underway that assesses inhaled nitric oxide as a treatment for patients with mild to moderate cases of COVID-19.
To date, there are no targeted therapeutic treatments for COVID-19 and there are no proven interventions to prevent progression of the disease. This clinical trial in particular will monitor patients with mild to moderate cases of COVID-19 to see how they respond to inhaled nitric oxide as a treatment. Preventing disease progression in spontaneously breathing patients with mild to moderate disease could help to reduce the number of severe cases and deaths, which in turn lessens demand on healthcare resources such a critical care physicians and nurses.
“We are excited to be approved for this early intervention treatment aimed at stopping the progression of the virus which gives patients an improved chance of recovering quickly by preventing the virus from worsening. This treatment will be especially important should we see an increase in the number of COVID-19 positive patients,” said Keith Scott, MD, MSc, FCCM, Professor and the clinical trial’s Principal Investigator at LSU Health Shreveport.
Massachusetts General Hospital reports that preliminary data suggests that inhaled nitric oxide could have a virus-killing effect on COVID-19, due to the genomic similarities between this virus and those that caused the SARS and MERS outbreaks. Studies during the SARS outbreak in 2004-05 demonstrated that nitric oxide was effective in killing that virus.
Patients in the clinical trial will be assigned to a treatment group or a control group. Patients in the treatment group will receive nitric oxide gas along with the standard of care for 30 minutes two times per day for 14 consecutive days. Patients in the control group will not receive the nitric oxide gas. Researchers will be monitoring patients to see if those receiving the nitric oxide gas had a reduced incidence of needing intubation and mechanical ventilation, which is common in patients with severe cases of COVID-19.
Nitric oxide has already been a miracle drug for newborns starved of oxygen by a heart defect due to the gas’s ability to relax blood vessels and the journal Science named nitric oxide the “molecule of the year” in 1992. UCLA pharmacologist Dr. Louis J. Ignarro shared a Nobel Prize in medicine in 1998 for uncovering nitric oxide’s role as a “signaling molecule in the cardiovascular system.”
“I can’t tell you how excited I am to see that inhaled Nitric Oxide is being tested for its effectiveness in patients with COVID-19. Having spent twelve years as a Professor in Louisiana, I am very proud that LSU Health Shreveport is conducting yet another clinical trial involving nitric oxide. I applaud these novel efforts to address this viral pandemic,” said Dr. Louis Ignarro, Nobel Prize Winning Scientist, Discoverer of Nitric Oxide, UCLA Emeritus, Ph.D. in Pharmacology.
In humans, nitric oxide is naturally generated by blood vessels and by some brain cells as well. It helps to regulate blood pressure, engulfs invading toxins, and prevents platelets in the blood from forming clots that may be significantly compromised during times of stress including infection thus warranting the need for a supplemental supply. When inflammation, emphysema or a disease like cystic fibrosis attacks the lungs, the large blood vessels and tiny capillaries that deliver oxygen constrict. Inhaled nitric oxide also relaxes those vessels, increasing the transfer of oxygen to the blood and easing the heart’s workload.
The Nitric Oxide Gas Inhalation Therapy for Mild/Moderate COVID-19 Infection clinical trial was conceived and sponsored by the Department of Anesthesia and the Respiratory Care Services at the Massachusetts General Hospital, which serves as the coordinating center for this international multicenter trial. In addition to LSU Health Shreveport, other collaborators are the University of Alabama at Birmingham, and academic medical centers in Austria and Sweden.