Trial of Famotidine & N-Acetyl Cysteine for Outpatients With COVID-19
- Registration Number
- NCT04545008
- Lead Sponsor
- Prisma Health-Upstate
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 2
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description High Dose N-Acetyl Cysteine and High Dose Famotidine N-Acetyl cysteine N-Acetyl Cysteine 1,800 mg three times daily Famotidine 80 mg three times daily Low Dose N-Acetyl Cysteine and High Dose Famotidine N-Acetyl cysteine N-Acetyl Cysteine 600 mg three times daily Famotidine 80 mg three times daily High Dose N-Acetyl Cysteine and Medium Dose Famotidine N-Acetyl cysteine N-Acetyl Cysteine 1,800 mg three times daily Famotidine 40 mg three times daily High Dose N-Acetyl Cysteine and Low Dose Famotidine N-Acetyl cysteine N-Acetyl Cysteine 1,800 mg three times daily Famotidine 20 mg three times daily Medium Dose N-Acetyl Cysteine and High Dose Famotidine N-Acetyl cysteine N-Acetyl Cysteine 1,200 mg three times daily Famotidine 80 mg three times daily Medium Dose N-Acetyl Cysteine N-Acetyl cysteine N-Acetyl Cysteine 1,200 mg three times daily Medium Dose N-Acetyl Cysteine and Medium Dose Famotidine N-Acetyl cysteine N-Acetyl Cysteine 1,200 mg three times daily Famotidine 40 mg three times daily Low Dose N-Acetyl Cysteine Alone N-Acetyl cysteine N-Acetyl Cysteine 600 mg three times daily Medium Dose N-Acetyl Cysteine and Low Dose Famotidine N-Acetyl cysteine N-Acetyl Cysteine 1,200 mg three times daily Famotidine 20 mg three times daily Low Dose N-Acetyl Cysteine and Low Dose Famotidine N-Acetyl cysteine N-Acetyl Cysteine 600 mg three times daily Famotidine 20 mg three times daily High Dose N-Acetyl Cysteine Alone N-Acetyl cysteine N-Acetyl Cysteine 1,800 mg three times daily Low Dose N-Acetyl Cysteine and Medium Dose Famotidine N-Acetyl cysteine N-Acetyl Cysteine 600 mg three times daily Famotidine 40 mg three times daily Low Dose N-Acetyl Cysteine and Low Dose Famotidine Famotidine N-Acetyl Cysteine 600 mg three times daily Famotidine 20 mg three times daily Medium Dose N-Acetyl Cysteine and Low Dose Famotidine Famotidine N-Acetyl Cysteine 1,200 mg three times daily Famotidine 20 mg three times daily Low Dose N-Acetyl Cysteine and Medium Dose Famotidine Famotidine N-Acetyl Cysteine 600 mg three times daily Famotidine 40 mg three times daily High Dose N-Acetyl Cysteine and Low Dose Famotidine Famotidine N-Acetyl Cysteine 1,800 mg three times daily Famotidine 20 mg three times daily Medium Dose N-Acetyl Cysteine and Medium Dose Famotidine Famotidine N-Acetyl Cysteine 1,200 mg three times daily Famotidine 40 mg three times daily High Dose N-Acetyl Cysteine and High Dose Famotidine Famotidine N-Acetyl Cysteine 1,800 mg three times daily Famotidine 80 mg three times daily Low Dose N-Acetyl Cysteine and High Dose Famotidine Famotidine N-Acetyl Cysteine 600 mg three times daily Famotidine 80 mg three times daily High Dose N-Acetyl Cysteine and Medium Dose Famotidine Famotidine N-Acetyl Cysteine 1,800 mg three times daily Famotidine 40 mg three times daily Medium Dose N-Acetyl Cysteine and High Dose Famotidine Famotidine N-Acetyl Cysteine 1,200 mg three times daily Famotidine 80 mg three times daily
- Primary Outcome Measures
Name Time Method Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0 0 to 30 days Data will be collected and entered into Case Report Form in local REDCap sever to include MedDRA Code, Grade and all other data required by NIH per Memorandum, "Guidance for Collection of Adverse Events Related to COVID-19 Infection" dated on 25 March 2020. All data will be reported per this memorandum and in accordance with all applicable Institutional Review Board and FDA requirements.
- Secondary Outcome Measures
Name Time Method Rate of Hospitalization 0 to 30 days Number of participants hospitalized
Time to Symptom Resolution 0 to 30 days Days to resolution of symptoms of infection.
Trial Locations
- Locations (3)
Prisma Health Greer Memorial Hospital
🇺🇸Greer, South Carolina, United States
Prisma Health Baptist Easley Hospital
🇺🇸Easley, South Carolina, United States
Prisma Health Greenville Memorial Hospital
🇺🇸Greenville, South Carolina, United States