Cambridge Health Alliance Launches Clinical Drug Trial for COVID-19 Treatment
Cambridge Health Alliance (CHA), an academic community health system serving Cambridge, Somerville and Boston's metro-north region, has launched its first-ever clinical drug trial (ClinicalTrials.gov #NCT04419025). The study explores whether N-acetylcysteine (NAC), a drug commonly used to treat acetaminophen (Tylenol) poisoning and to prevent exacerbations of COPD (emphysema), can prevent mild to moderate COVID-19 symptoms in patients from progressing to severe disease.
CAMBRIDGE, Mass. -- Cambridge Health Alliance (CHA), an academic community health system serving Cambridge, Somerville and Boston's metro-north region, has launched its first-ever clinical drug trial (ClinicalTrials.gov #NCT04419025). The study explores whether N-acetylcysteine (NAC), a drug commonly used to treat acetaminophen (Tylenol) poisoning and to prevent exacerbations of COPD (emphysema), can prevent mild to moderate COVID-19 symptoms in patients from progressing to severe disease.
“We are hoping to prove that this already commonly used drug can help to slow and prevent worsening of mild or moderate COVID-19 symptoms, and decrease hospitalizations and the need for mechanical ventilation or intubations,” said Melisa Lai-Becker, MD, site chief of emergency medicine at CHA Everett Hospital, who is spearheading the study with a multidisciplinary team of staff and providers.
NAC was approved by the U.S. Food and Drug Administration in the 1970s and, with its extremely low risk profile, is considered one of the safest drugs available. It is used by the body to build antioxidants that protect and repair cells from damage. In advance of this current open-label clinical trial, CHA providers have offered NAC off-label to approximately 200 patients and anecdotally seen positive results since the outbreak of COVID-19.
Dr. Lai-Becker and her co-investigators believe NAC could be an effective treatment therapy for COVID-19. NAC is an anti-inflammatory and immunomodulatory agent and a powerful antioxidant that can minimize the reactive oxygen species that incite inflammation of severe COVID-19. The drug also has antithrombotic (anti-blood-clotting) properties that may be beneficial because COVID-19 appears to increase the development of microscopic blood clots that increase inflammatory damage and cause stroke and heart attack in certain patients.
Beyond the health benefits of NAC, the drug also has economic and health equity value. NAC in oral capsule or caplet form is an inexpensive drug that ranges from $0.07 - $0.23 per capsule. NAC is available by prescription but also can be purchased over-the-counter due to its dual classification as medication and a dietary supplement.
Patients diagnosed with COVID-19 who present to either of the emergency departments at CHA Everett Hospital or CHA Cambridge Hospital, or who are seen at CHA’s Acute Care Clinic (Respiratory Clinic) in Somerville, are currently being screened for a match with the study’s eligibility criteria. Those who match may volunteer to enroll in the study. Patients with COVID-19 who do not enroll in the study may still receive NAC if they and their provider would like to try it.
This study is non-funded/non-sponsored, and the team is actively searching for funding sources. Community members interested in donating to support this and other research at CHA may contact the CHA Foundation by e-mailing ldornjones@challiance.org or visiting the Foundation’s website and selecting “NACinCOVID Clinical Trial.”
Additionally, the researchers are preparing to conduct another clinical trial with NAC -- a randomized double-blind placebo-controlled trial -- replicating a two-decade-old study showing that when taken prophylactically, NAC significantly reduces the severity of (and in some cases eliminated) flu symptoms. They are hoping to secure funding in order to move forward with this second study.
For more information about N-acetylcysteine (NAC) and COVID and CHA’s clinical trial, visit www.nacincovid.info.
CHA is an academic community health system committed to providing high quality care in Cambridge, Somerville and Boston’s metro-north communities. CHA has expertise in primary care, specialty care and mental health/substance use services, as well as caring for diverse and complex populations. It includes two hospital campuses, a network of primary care and specialty practices and the Cambridge Public Health Dept. CHA patients have seamless access to advanced care through the system’s affiliation with Beth Israel Deaconess Medical Center in Boston. CHA is a Harvard Medical School teaching affiliate and is also affiliated with the Harvard T.H. Chan School of Public Health, Harvard School of Dental Medicine and Tufts University School of Medicine.