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

Sponsors

Lead Sponsor: Prisma Health-Upstate

Collaborator: Clemson University

Source 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.

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.

Overall Status Not yet recruiting
Start Date September 2020
Completion Date August 2021
Primary Completion Date March 2021
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 0 to 3 months
Secondary Outcome
Measure Time Frame
Rate of Hospitalization 0 to 3 months
Time to Symptom Resolution 0 to 3 months
Enrollment 42
Condition
Intervention

Intervention Type: Drug

Intervention Name: Famotidine

Description: Oral Famotidine

Other Name: Pepcid AC

Intervention Type: Drug

Intervention Name: N-Acetyl cysteine

Description: Oral N-Acetyl Cysteine

Eligibility

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Contact

Last Name: John J O'Connell, M.D.

Phone: (864)679-3900

Email: John.O'[email protected]

Verification Date

September 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Number Of Arms 12
Arm Group

Label: Low Dose N-Acetyl Cysteine Alone

Type: Experimental

Description: N-Acetyl Cysteine 600 mg three times daily

Label: Medium Dose N-Acetyl Cysteine

Type: Experimental

Description: N-Acetyl Cysteine 1,200 mg three times daily

Label: Low Dose N-Acetyl Cysteine and Low Dose Famotidine

Type: Experimental

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

Label: High Dose N-Acetyl Cysteine Alone

Type: Experimental

Description: N-Acetyl Cysteine 1,800 mg three times daily

Label: Medium Dose N-Acetyl Cysteine and Low Dose Famotidine

Type: Experimental

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

Label: Low Dose N-Acetyl Cysteine and Medium Dose Famotidine

Type: Experimental

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

Label: High Dose N-Acetyl Cysteine and Low Dose Famotidine

Type: Experimental

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

Label: Medium Dose N-Acetyl Cysteine and Medium Dose Famotidine

Type: Experimental

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

Label: Low Dose N-Acetyl Cysteine and High Dose Famotidine

Type: Experimental

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

Label: High Dose N-Acetyl Cysteine and Medium Dose Famotidine

Type: Experimental

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

Label: Medium Dose N-Acetyl Cysteine and High Dose Famotidine

Type: Experimental

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

Label: High Dose N-Acetyl Cysteine and High Dose Famotidine

Type: Experimental

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

Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov