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.

Study Overview

• Status: Terminated
• Conditions: Covid19
• Intervention / Treatment: Drug: N-Acetyl cysteine; Drug: Famotidine

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.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Easley, South Carolina, United States, 29640
      • Prisma Health Baptist Easley Hospital
    • Greenville, South Carolina, United States, 29605
      • Prisma Health Greenville Memorial Hospital
    • Greer, South Carolina, United States, 29650
      • Prisma Health Greer Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

12

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low Dose N-Acetyl Cysteine Alone; N-Acetyl Cysteine 600 mg three times daily	Drug: N-Acetyl cysteine; Oral N-Acetyl Cysteine; Other Names: NAC
Experimental: Medium Dose N-Acetyl Cysteine; N-Acetyl Cysteine 1,200 mg three times daily	Drug: N-Acetyl cysteine; Oral N-Acetyl Cysteine; Other Names: NAC
Experimental: Low Dose N-Acetyl Cysteine and Low Dose Famotidine; N-Acetyl Cysteine 600 mg three times daily Famotidine 20 mg three times daily	Drug: N-Acetyl cysteine; Oral N-Acetyl Cysteine; Other Names: NAC; Drug: Famotidine; Oral Famotidine; Other Names: Pepcid AC
Experimental: High Dose N-Acetyl Cysteine Alone; N-Acetyl Cysteine 1,800 mg three times daily	Drug: N-Acetyl cysteine; Oral N-Acetyl Cysteine; Other Names: NAC
Experimental: Medium Dose N-Acetyl Cysteine and Low Dose Famotidine; N-Acetyl Cysteine 1,200 mg three times daily Famotidine 20 mg three times daily	Drug: N-Acetyl cysteine; Oral N-Acetyl Cysteine; Other Names: NAC; Drug: Famotidine; Oral Famotidine; Other Names: Pepcid AC
Experimental: Low Dose N-Acetyl Cysteine and Medium Dose Famotidine; N-Acetyl Cysteine 600 mg three times daily Famotidine 40 mg three times daily	Drug: N-Acetyl cysteine; Oral N-Acetyl Cysteine; Other Names: NAC; Drug: Famotidine; Oral Famotidine; Other Names: Pepcid AC
Experimental: High Dose N-Acetyl Cysteine and Low Dose Famotidine; N-Acetyl Cysteine 1,800 mg three times daily Famotidine 20 mg three times daily	Drug: N-Acetyl cysteine; Oral N-Acetyl Cysteine; Other Names: NAC; Drug: Famotidine; Oral Famotidine; Other Names: Pepcid AC
Experimental: Medium Dose N-Acetyl Cysteine and Medium Dose Famotidine; N-Acetyl Cysteine 1,200 mg three times daily Famotidine 40 mg three times daily	Drug: N-Acetyl cysteine; Oral N-Acetyl Cysteine; Other Names: NAC; Drug: Famotidine; Oral Famotidine; Other Names: Pepcid AC
Experimental: Low Dose N-Acetyl Cysteine and High Dose Famotidine; N-Acetyl Cysteine 600 mg three times daily Famotidine 80 mg three times daily	Drug: N-Acetyl cysteine; Oral N-Acetyl Cysteine; Other Names: NAC; Drug: Famotidine; Oral Famotidine; Other Names: Pepcid AC
Experimental: High Dose N-Acetyl Cysteine and Medium Dose Famotidine; N-Acetyl Cysteine 1,800 mg three times daily Famotidine 40 mg three times daily	Drug: N-Acetyl cysteine; Oral N-Acetyl Cysteine; Other Names: NAC; Drug: Famotidine; Oral Famotidine; Other Names: Pepcid AC
Experimental: Medium Dose N-Acetyl Cysteine and High Dose Famotidine; N-Acetyl Cysteine 1,200 mg three times daily Famotidine 80 mg three times daily	Drug: N-Acetyl cysteine; Oral N-Acetyl Cysteine; Other Names: NAC; Drug: Famotidine; Oral Famotidine; Other Names: Pepcid AC
Experimental: High Dose N-Acetyl Cysteine and High Dose Famotidine; N-Acetyl Cysteine 1,800 mg three times daily Famotidine 80 mg three times daily	Drug: N-Acetyl cysteine; Oral N-Acetyl Cysteine; Other Names: NAC; Drug: Famotidine; Oral Famotidine; Other Names: Pepcid AC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0	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.	0 to 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Hospitalization	Number of participants hospitalized	0 to 30 days
Time to Symptom Resolution	Days to resolution of symptoms of infection.	0 to 30 days

Collaborators and Investigators

• Sponsor: Prisma Health-Upstate
• Collaborators: Clemson University
• Investigators: Principal Investigator: John J O'Connell, M.D., Prisma Health

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2020
• Primary Completion (Actual): June 2, 2021
• Study Completion (Actual): June 2, 2021

Study Registration Dates

• First Submitted: September 1, 2020
• First Submitted That Met QC Criteria: September 9, 2020
• First Posted (Actual): September 10, 2020

Study Record Updates

• Last Update Posted (Actual): February 18, 2022
• Last Update Submitted That Met QC Criteria: February 16, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: outpatient; famotidine; n-acetyl cysteine
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Gastrointestinal Agents; Protective Agents; Respiratory System Agents; Anti-Ulcer Agents; Antioxidants; Antidotes; Histamine Antagonists; Histamine Agents; Free Radical Scavengers; Expectorants; Histamine H2 Antagonists; Acetylcysteine; N-monoacetylcystine; Famotidine
• Other Study ID Numbers: Pro00100394

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No