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

Phase 1TerminatedNCT04545008

Prisma Health-Upstate2 enrolled

Overview

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.

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Covid19

Interventions

FamotidineDRUG

Oral Famotidine

N-Acetyl cysteineDRUG

Oral N-Acetyl Cysteine

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Prisma Health Baptist Easley Hospital

Easley, South Carolina, United States

Prisma Health Greenville Memorial Hospital

Greenville, South Carolina, United States

Prisma Health Greer Memorial Hospital

Greer, South Carolina, United States

Outcomes

Primary Outcomes

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.

Time frame: 0 to 30 days

Secondary Outcomes

Rate of Hospitalization

Number of participants hospitalized

Time frame: 0 to 30 days

Time to Symptom Resolution

Days to resolution of symptoms of infection.

Time frame: 0 to 30 days

Data from ClinicalTrials.gov

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