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

• ClinicalTrials.gov Identifier: NCT04545008
• Recruitment Status: Recruiting
• First Posted: September 10, 2020
• Last Update Posted: March 10, 2021
• Sponsor: Prisma Health-Upstate
• Collaborator: Clemson University
• Information provided by (Responsible Party): Prisma Health-Upstate

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Covid19	Drug: Famotidine; Drug: N-Acetyl cysteine	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: October 20, 2020
• Estimated Primary Completion Date: September 30, 2021
• Estimated Study Completion Date: October 31, 2021

Arms and Interventions

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
Experimental: Medium Dose N-Acetyl Cysteine; N-Acetyl Cysteine 1,200 mg three times daily	Drug: N-Acetyl cysteine; Oral N-Acetyl Cysteine
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: Famotidine; Oral Famotidine; Other Name: Pepcid AC; Drug: N-Acetyl cysteine; Oral N-Acetyl Cysteine
Experimental: High Dose N-Acetyl Cysteine Alone; N-Acetyl Cysteine 1,800 mg three times daily	Drug: N-Acetyl cysteine; Oral N-Acetyl Cysteine
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: Famotidine; Oral Famotidine; Other Name: Pepcid AC; Drug: N-Acetyl cysteine; Oral N-Acetyl Cysteine
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: Famotidine; Oral Famotidine; Other Name: Pepcid AC; Drug: N-Acetyl cysteine; Oral N-Acetyl Cysteine
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: Famotidine; Oral Famotidine; Other Name: Pepcid AC; Drug: N-Acetyl cysteine; Oral N-Acetyl Cysteine
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: Famotidine; Oral Famotidine; Other Name: Pepcid AC; Drug: N-Acetyl cysteine; Oral N-Acetyl Cysteine
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: Famotidine; Oral Famotidine; Other Name: Pepcid AC; Drug: N-Acetyl cysteine; Oral N-Acetyl Cysteine
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: Famotidine; Oral Famotidine; Other Name: Pepcid AC; Drug: N-Acetyl cysteine; Oral N-Acetyl Cysteine
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: Famotidine; Oral Famotidine; Other Name: Pepcid AC; Drug: N-Acetyl cysteine; Oral N-Acetyl Cysteine
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: Famotidine; Oral Famotidine; Other Name: Pepcid AC; Drug: N-Acetyl cysteine; Oral N-Acetyl Cysteine

Outcome Measures

Primary Outcome Measures :

1. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [ Time Frame: 0 to 3 months ]
   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 :

1. Rate of Hospitalization [ Time Frame: 0 to 3 months ]
2. Time to Symptom Resolution [ Time Frame: 0 to 3 months ]

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Contacts

Contact: John J O'Connell, M.D.; (864)679-3900; John.O'Connell@PrismaHealth.org

Contact: Julie Martin, DNP; (864)679-3900; Julie.Martin@PrismaHealth.org

Locations

United States, South Carolina

Prisma Health Baptist Easley Hospital; Recruiting

Easley, South Carolina, United States, 29640

Contact: Stacy Parkhurst, BSN, RN, OCN

Prisma Health Greenville Memorial Hospital; Recruiting

Greenville, South Carolina, United States, 29605

Contact: Stacy Parkhurst, BSN, RN, OCN

Prisma Health Greer Memorial Hospital; Recruiting

Greer, South Carolina, United States, 29650

Contact: Stacy Parkhurst, BSN, RN, OCN

Sponsors and Collaborators

Prisma Health-Upstate

Clemson University

More Information

• Responsible Party: Prisma Health-Upstate
• ClinicalTrials.gov Identifier: NCT04545008
• Other Study ID Numbers: Pro00100394
• First Posted: September 10, 2020
• Last Update Posted: March 10, 2021
• Last Verified: March 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Prisma Health-Upstate:

outpatient; famotidine; n-acetyl cysteine

Additional relevant MeSH terms:

Acetylcysteine; N-monoacetylcystine; Famotidine; Antiviral Agents; Anti-Infective Agents; Expectorants; Respiratory System Agents; Free Radical Scavengers; Antioxidants; Molecular Mechanisms of Pharmacological Action; Protective Agents; Physiological Effects of Drugs; Antidotes; Anti-Ulcer Agents; Gastrointestinal Agents; Histamine H2 Antagonists; Histamine Antagonists; Histamine Agents; Neurotransmitter Agents