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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • 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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Prisma Health-Upstate

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Clemson University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 20, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 2, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 2, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 1, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 10, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 18, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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.

Clinical Trials on Covid19

Clinical Trials on N-Acetyl cysteine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings