NCT04545008

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

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Prisma Health-Upstate · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Covid19

Interventions

Type	Name	Description
DRUG	Famotidine	Oral Famotidine
DRUG	N-Acetyl cysteine	Oral N-Acetyl Cysteine

Timeline

• Start date: 2020-10-20
• Primary completion: 2021-06-02
• Completion: 2021-06-02
• First posted: 2020-09-10
• Last updated: 2022-02-18
• Results posted: 2022-02-18

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study