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

NCT ID: NCT04545008

Last Updated: 2022-02-18

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-20

Study Completion Date

2021-06-02

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Covid19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Low Dose N-Acetyl Cysteine Alone

N-Acetyl Cysteine 600 mg three times daily

Group Type EXPERIMENTAL

N-Acetyl cysteine

Intervention Type DRUG

Oral N-Acetyl Cysteine

Medium Dose N-Acetyl Cysteine

N-Acetyl Cysteine 1,200 mg three times daily

Group Type EXPERIMENTAL

N-Acetyl cysteine

Intervention Type DRUG

Oral N-Acetyl Cysteine

Low Dose N-Acetyl Cysteine and Low Dose Famotidine

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

Group Type EXPERIMENTAL

Famotidine

Intervention Type DRUG

Oral Famotidine

N-Acetyl cysteine

Intervention Type DRUG

Oral N-Acetyl Cysteine

High Dose N-Acetyl Cysteine Alone

N-Acetyl Cysteine 1,800 mg three times daily

Group Type EXPERIMENTAL

N-Acetyl cysteine

Intervention Type DRUG

Oral N-Acetyl Cysteine

Medium Dose N-Acetyl Cysteine and Low Dose Famotidine

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

Group Type EXPERIMENTAL

Famotidine

Intervention Type DRUG

Oral Famotidine

N-Acetyl cysteine

Intervention Type DRUG

Oral N-Acetyl Cysteine

Low Dose N-Acetyl Cysteine and Medium Dose Famotidine

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

Group Type EXPERIMENTAL

Famotidine

Intervention Type DRUG

Oral Famotidine

N-Acetyl cysteine

Intervention Type DRUG

Oral N-Acetyl Cysteine

High Dose N-Acetyl Cysteine and Low Dose Famotidine

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

Group Type EXPERIMENTAL

Famotidine

Intervention Type DRUG

Oral Famotidine

N-Acetyl cysteine

Intervention Type DRUG

Oral N-Acetyl Cysteine

Medium Dose N-Acetyl Cysteine and Medium Dose Famotidine

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

Group Type EXPERIMENTAL

Famotidine

Intervention Type DRUG

Oral Famotidine

N-Acetyl cysteine

Intervention Type DRUG

Oral N-Acetyl Cysteine

Low Dose N-Acetyl Cysteine and High Dose Famotidine

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

Group Type EXPERIMENTAL

Famotidine

Intervention Type DRUG

Oral Famotidine

N-Acetyl cysteine

Intervention Type DRUG

Oral N-Acetyl Cysteine

High Dose N-Acetyl Cysteine and Medium Dose Famotidine

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

Group Type EXPERIMENTAL

Famotidine

Intervention Type DRUG

Oral Famotidine

N-Acetyl cysteine

Intervention Type DRUG

Oral N-Acetyl Cysteine

Medium Dose N-Acetyl Cysteine and High Dose Famotidine

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

Group Type EXPERIMENTAL

Famotidine

Intervention Type DRUG

Oral Famotidine

N-Acetyl cysteine

Intervention Type DRUG

Oral N-Acetyl Cysteine

High Dose N-Acetyl Cysteine and High Dose Famotidine

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

Group Type EXPERIMENTAL

Famotidine

Intervention Type DRUG

Oral Famotidine

N-Acetyl cysteine

Intervention Type DRUG

Oral N-Acetyl Cysteine

Interventions

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Famotidine

Oral Famotidine

Intervention Type DRUG

N-Acetyl cysteine

Oral N-Acetyl Cysteine

Intervention Type DRUG

Other Intervention Names

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Pepcid AC NAC

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clemson University

OTHER

Sponsor Role collaborator

Prisma Health-Upstate

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John J O'Connell, M.D.

Role: PRINCIPAL_INVESTIGATOR

Prisma Health

Locations

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Prisma Health Baptist Easley Hospital

Easley, South Carolina, United States

Site Status

Prisma Health Greenville Memorial Hospital

Greenville, South Carolina, United States

Site Status

Prisma Health Greer Memorial Hospital

Greer, South Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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Pro00100394

Identifier Type: -

Identifier Source: org_study_id

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