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

February 16, 2022 updated by: Prisma Health-Upstate

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

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low Dose N-Acetyl Cysteine Alone
N-Acetyl Cysteine 600 mg three times daily
Oral N-Acetyl Cysteine
Other Names:
  • NAC
Experimental: Medium Dose N-Acetyl Cysteine
N-Acetyl Cysteine 1,200 mg three times daily
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
Oral N-Acetyl Cysteine
Other Names:
  • NAC
Oral Famotidine
Other Names:
  • Pepcid AC
Experimental: High Dose N-Acetyl Cysteine Alone
N-Acetyl Cysteine 1,800 mg three times daily
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
Oral N-Acetyl Cysteine
Other Names:
  • NAC
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
Oral N-Acetyl Cysteine
Other Names:
  • NAC
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
Oral N-Acetyl Cysteine
Other Names:
  • NAC
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
Oral N-Acetyl Cysteine
Other Names:
  • NAC
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
Oral N-Acetyl Cysteine
Other Names:
  • NAC
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
Oral N-Acetyl Cysteine
Other Names:
  • NAC
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
Oral N-Acetyl Cysteine
Other Names:
  • NAC
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
Oral N-Acetyl Cysteine
Other Names:
  • NAC
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
Time Frame: 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.
0 to 30 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: John J O'Connell, M.D., Prisma Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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