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

Primary Purpose

Covid19

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Famotidine
N-Acetyl cysteine
Sponsored by
Prisma Health-Upstate
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring outpatient, famotidine, n-acetyl cysteine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Prisma Health Baptist Easley Hospital
  • Prisma Health Greenville Memorial Hospital
  • Prisma Health Greer Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Low Dose N-Acetyl Cysteine Alone

Medium Dose N-Acetyl Cysteine

Low Dose N-Acetyl Cysteine and Low Dose Famotidine

High Dose N-Acetyl Cysteine Alone

Medium Dose N-Acetyl Cysteine and Low Dose Famotidine

Low Dose N-Acetyl Cysteine and Medium Dose Famotidine

High Dose N-Acetyl Cysteine and Low Dose Famotidine

Medium Dose N-Acetyl Cysteine and Medium Dose Famotidine

Low Dose N-Acetyl Cysteine and High Dose Famotidine

High Dose N-Acetyl Cysteine and Medium Dose Famotidine

Medium Dose N-Acetyl Cysteine and High Dose Famotidine

High Dose N-Acetyl Cysteine and High Dose Famotidine

Arm Description

N-Acetyl Cysteine 600 mg three times daily

N-Acetyl Cysteine 1,200 mg three times daily

N-Acetyl Cysteine 600 mg three times daily Famotidine 20 mg three times daily

N-Acetyl Cysteine 1,800 mg three times daily

N-Acetyl Cysteine 1,200 mg three times daily Famotidine 20 mg three times daily

N-Acetyl Cysteine 600 mg three times daily Famotidine 40 mg three times daily

N-Acetyl Cysteine 1,800 mg three times daily Famotidine 20 mg three times daily

N-Acetyl Cysteine 1,200 mg three times daily Famotidine 40 mg three times daily

N-Acetyl Cysteine 600 mg three times daily Famotidine 80 mg three times daily

N-Acetyl Cysteine 1,800 mg three times daily Famotidine 40 mg three times daily

N-Acetyl Cysteine 1,200 mg three times daily Famotidine 80 mg three times daily

N-Acetyl Cysteine 1,800 mg three times daily Famotidine 80 mg three times daily

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Rate of Hospitalization
Number of participants hospitalized
Time to Symptom Resolution
Days to resolution of symptoms of infection.

Full Information

First Posted
September 1, 2020
Last Updated
February 16, 2022
Sponsor
Prisma Health-Upstate
Collaborators
Clemson University
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1. Study Identification

Unique Protocol Identification Number
NCT04545008
Brief Title
Trial of Famotidine & N-Acetyl Cysteine for Outpatients With COVID-19
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Terminated
Why Stopped
Study was stopped due to poor accrual.
Study Start Date
October 20, 2020 (Actual)
Primary Completion Date
June 2, 2021 (Actual)
Study Completion Date
June 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Prisma Health-Upstate
Collaborators
Clemson University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
outpatient, famotidine, n-acetyl cysteine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low Dose N-Acetyl Cysteine Alone
Arm Type
Experimental
Arm Description
N-Acetyl Cysteine 600 mg three times daily
Arm Title
Medium Dose N-Acetyl Cysteine
Arm Type
Experimental
Arm Description
N-Acetyl Cysteine 1,200 mg three times daily
Arm Title
Low Dose N-Acetyl Cysteine and Low Dose Famotidine
Arm Type
Experimental
Arm Description
N-Acetyl Cysteine 600 mg three times daily Famotidine 20 mg three times daily
Arm Title
High Dose N-Acetyl Cysteine Alone
Arm Type
Experimental
Arm Description
N-Acetyl Cysteine 1,800 mg three times daily
Arm Title
Medium Dose N-Acetyl Cysteine and Low Dose Famotidine
Arm Type
Experimental
Arm Description
N-Acetyl Cysteine 1,200 mg three times daily Famotidine 20 mg three times daily
Arm Title
Low Dose N-Acetyl Cysteine and Medium Dose Famotidine
Arm Type
Experimental
Arm Description
N-Acetyl Cysteine 600 mg three times daily Famotidine 40 mg three times daily
Arm Title
High Dose N-Acetyl Cysteine and Low Dose Famotidine
Arm Type
Experimental
Arm Description
N-Acetyl Cysteine 1,800 mg three times daily Famotidine 20 mg three times daily
Arm Title
Medium Dose N-Acetyl Cysteine and Medium Dose Famotidine
Arm Type
Experimental
Arm Description
N-Acetyl Cysteine 1,200 mg three times daily Famotidine 40 mg three times daily
Arm Title
Low Dose N-Acetyl Cysteine and High Dose Famotidine
Arm Type
Experimental
Arm Description
N-Acetyl Cysteine 600 mg three times daily Famotidine 80 mg three times daily
Arm Title
High Dose N-Acetyl Cysteine and Medium Dose Famotidine
Arm Type
Experimental
Arm Description
N-Acetyl Cysteine 1,800 mg three times daily Famotidine 40 mg three times daily
Arm Title
Medium Dose N-Acetyl Cysteine and High Dose Famotidine
Arm Type
Experimental
Arm Description
N-Acetyl Cysteine 1,200 mg three times daily Famotidine 80 mg three times daily
Arm Title
High Dose N-Acetyl Cysteine and High Dose Famotidine
Arm Type
Experimental
Arm Description
N-Acetyl Cysteine 1,800 mg three times daily Famotidine 80 mg three times daily
Intervention Type
Drug
Intervention Name(s)
Famotidine
Other Intervention Name(s)
Pepcid AC
Intervention Description
Oral Famotidine
Intervention Type
Drug
Intervention Name(s)
N-Acetyl cysteine
Other Intervention Name(s)
NAC
Intervention Description
Oral N-Acetyl Cysteine
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0
Description
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.
Time Frame
0 to 30 days
Secondary Outcome Measure Information:
Title
Rate of Hospitalization
Description
Number of participants hospitalized
Time Frame
0 to 30 days
Title
Time to Symptom Resolution
Description
Days to resolution of symptoms of infection.
Time Frame
0 to 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John J O'Connell, M.D.
Organizational Affiliation
Prisma Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prisma Health Baptist Easley Hospital
City
Easley
State/Province
South Carolina
ZIP/Postal Code
29640
Country
United States
Facility Name
Prisma Health Greenville Memorial Hospital
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Prisma Health Greer Memorial Hospital
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29650
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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