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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
Last Update Posted : August 4, 2021
Sponsor:
Collaborator:
Clemson University
Information provided by (Responsible Party):
Prisma Health-Upstate

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 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
Actual Primary Completion Date : June 2, 2021
Actual Study Completion Date : June 2, 2021

Resource links provided by the National Library of Medicine


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




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 ]


Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04545008


Locations
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United States, South Carolina
Prisma Health Baptist Easley Hospital
Easley, South Carolina, United States, 29640
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, United States, 29605
Prisma Health Greer Memorial Hospital
Greer, South Carolina, United States, 29650
Sponsors and Collaborators
Prisma Health-Upstate
Clemson University
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Responsible Party: Prisma Health-Upstate
ClinicalTrials.gov Identifier: NCT04545008    
Other Study ID Numbers: Pro00100394
First Posted: September 10, 2020    Key Record Dates
Last Update Posted: August 4, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Acetylcysteine
Famotidine
N-monoacetylcystine
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