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

Purpose

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

  • Covid19

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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: Famotidine
    Oral Famotidine
    Other names:
    • Pepcid AC
  • Drug: N-Acetyl cysteine
    Oral N-Acetyl Cysteine
    Other names:
    • NAC
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: Famotidine
    Oral Famotidine
    Other names:
    • Pepcid AC
  • Drug: N-Acetyl cysteine
    Oral N-Acetyl Cysteine
    Other names:
    • NAC
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 names:
    • Pepcid AC
  • Drug: N-Acetyl cysteine
    Oral N-Acetyl Cysteine
    Other names:
    • NAC
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 names:
    • Pepcid AC
  • Drug: N-Acetyl cysteine
    Oral N-Acetyl Cysteine
    Other names:
    • NAC
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 names:
    • Pepcid AC
  • Drug: N-Acetyl cysteine
    Oral N-Acetyl Cysteine
    Other names:
    • NAC
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 names:
    • Pepcid AC
  • Drug: N-Acetyl cysteine
    Oral N-Acetyl Cysteine
    Other names:
    • NAC
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 names:
    • Pepcid AC
  • Drug: N-Acetyl cysteine
    Oral N-Acetyl Cysteine
    Other names:
    • NAC
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 names:
    • Pepcid AC
  • Drug: N-Acetyl cysteine
    Oral N-Acetyl Cysteine
    Other names:
    • NAC
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 names:
    • Pepcid AC
  • Drug: N-Acetyl cysteine
    Oral N-Acetyl Cysteine
    Other names:
    • NAC

Recruiting Locations

More Details

NCT ID
NCT04545008
Status
Terminated
Sponsor
Prisma Health-Upstate

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.