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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04545008
• Other study ID #: Pro00100394
• Status: Terminated
• Phase: Phase 1
• Start date: October 20, 2020
• Est. completion date: June 2, 2021

Study information

• Verified date: February 2022
• Source: Prisma Health-Upstate
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: June 2, 2021
• Est. primary completion date: June 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Drug:
• Famotidine
Oral Famotidine
• N-Acetyl cysteine
Oral N-Acetyl Cysteine

Locations

Country	Name	City	State
United States	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

Sponsors (2)

Lead Sponsor	Collaborator
Prisma Health-Upstate	Clemson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	0 to 30 days
Secondary	Rate of Hospitalization	Number of participants hospitalized	0 to 30 days
Secondary	Time to Symptom Resolution	Days to resolution of symptoms of infection.	0 to 30 days