The purpose of this trial is to assess the safety and toxicity profile of the combination of famotidine and oral n-acetyl cysteine in adult outpatients with newly diagnosed SARS-CoV-2 infection.
This is a phase I trial enrolling subjects with newly diagnosed SARS-CoV-2 infection who do
not require hospitalization. Exclusion criteria have been written to exclude patients who
would be expected to have increased risk from either medication alone. Subjects will be
assigned a dose combination of famotidine and n-acetyl cysteine. In addition to assessing the
safety and toxicities profiles of the combination of drugs we will be measuring certain
endpoints to assess possible efficacy. These endpoint include the following: rates of
hospitalization; time to complete remission of symptoms, e.g, fever, respiratory symptoms,
etc.; severity of symptoms with validated survey instruments; cytokine values in serum and
urine; and markers of inflammation and oxidative stress.
Drug: Famotidine
Oral Famotidine
Other Name: Pepcid AC
Drug: N-Acetyl cysteine
Oral N-Acetyl Cysteine
Other Name: NAC
Inclusion Criteria:
- Age > 18
- performance of a SARS-CoV-2 test within 1 day of enrollment, N.B., must be positive to
proceed to treatment phase of the trial
Exclusion Criteria:
- All patients under 18
- Known allergy to N-Acetyl Cysteine
- Known allergy to famotidine or other H2-receptor antagonists
- Pregnant or Nursing Mothers
- Laboratory Evidence or History of Renal Impairment (eGFR < 30 mL/min/1.73 m2)
- Taking H2-receptor antagonists, hydroxychloroquine or chloroquine.
- Patient has been admitted to the hospital prior to study enrollment
Prisma Health Baptist Easley Hospital
Easley, South Carolina, United States
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, United States
Prisma Health Greer Memorial Hospital
Greer, South Carolina, United States
John J O'Connell, M.D., Principal Investigator
Prisma Health