Trial of Famotidine & N-Acetyl Cysteine for Outpatients With COVID-19

A Phase I Clinical Trial of the Combination of Famotidine (FAM) and Oral N-Acetyl Cysteine (NAC) Open Label for Outpatient Treatment of Subjects With Newly Diagnosed SARS-CoV-2 Infection

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.

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