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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04545008
Recruitment Status : Terminated (Study was stopped due to poor accrual.)
First Posted : September 10, 2020
Results First Posted : February 18, 2022
Last Update Posted : February 18, 2022
Sponsor:
Collaborator:
Clemson University
Information provided by (Responsible Party):
Prisma Health-Upstate

Tracking Information
First Submitted Date  ICMJE September 1, 2020
First Posted Date  ICMJE September 10, 2020
Results First Submitted Date  ICMJE February 4, 2022
Results First Posted Date  ICMJE February 18, 2022
Last Update Posted Date February 18, 2022
Actual Study Start Date  ICMJE October 20, 2020
Actual Primary Completion Date June 2, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 16, 2022)		 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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 9, 2020)		 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 16, 2022)
  • Rate of Hospitalization [ Time Frame: 0 to 30 days ]
    Number of participants hospitalized
  • Time to Symptom Resolution [ Time Frame: 0 to 30 days ]
    Days to resolution of symptoms of infection.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2020)
  • Rate of Hospitalization [ Time Frame: 0 to 3 months ]
  • Time to Symptom Resolution [ Time Frame: 0 to 3 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of Famotidine & N-Acetyl Cysteine for Outpatients With COVID-19
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Covid19
Intervention  ICMJE
  • Drug: Famotidine
    Oral Famotidine
    Other Name: Pepcid AC
  • Drug: N-Acetyl cysteine
    Oral N-Acetyl Cysteine
    Other Name: NAC
Study Arms  ICMJE
  • Experimental: Low Dose N-Acetyl Cysteine Alone
    N-Acetyl Cysteine 600 mg three times daily
    Intervention: Drug: N-Acetyl cysteine
  • Experimental: Medium Dose N-Acetyl Cysteine
    N-Acetyl Cysteine 1,200 mg three times daily
    Intervention: Drug: 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
    Interventions:
    • Drug: Famotidine
    • Drug: N-Acetyl cysteine
  • Experimental: High Dose N-Acetyl Cysteine Alone
    N-Acetyl Cysteine 1,800 mg three times daily
    Intervention: Drug: 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
    Interventions:
    • Drug: Famotidine
    • Drug: 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
    Interventions:
    • Drug: Famotidine
    • Drug: 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
    Interventions:
    • Drug: Famotidine
    • Drug: 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
    Interventions:
    • Drug: Famotidine
    • Drug: 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
    Interventions:
    • Drug: Famotidine
    • Drug: 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
    Interventions:
    • Drug: Famotidine
    • Drug: 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
    Interventions:
    • Drug: Famotidine
    • Drug: 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
    Interventions:
    • Drug: Famotidine
    • Drug: N-Acetyl cysteine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 28, 2021)		 2
Original Estimated Enrollment  ICMJE
 (submitted: September 9, 2020)		 42
Actual Study Completion Date  ICMJE June 2, 2021
Actual Primary Completion Date June 2, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04545008
Other Study ID Numbers  ICMJE Pro00100394
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Prisma Health-Upstate
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Prisma Health-Upstate
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Clemson University
Investigators  ICMJE
Principal Investigator: John J O'Connell, M.D. Prisma Health
PRS Account Prisma Health-Upstate
Verification Date February 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP