Study Stopped
Study was stopped due to poor accrual.
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
1 other identifier
interventional
2
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 covid19
Started Oct 2020
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 1, 2020
CompletedFirst Posted
Study publicly available on registry
September 10, 2020
CompletedStudy Start
First participant enrolled
October 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 2, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 2, 2021
CompletedResults Posted
Study results publicly available
February 18, 2022
CompletedFebruary 18, 2022
February 1, 2022
8 months
September 1, 2020
February 4, 2022
February 16, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Rate of Hospitalization
0 to 30 days
Time to Symptom Resolution
0 to 30 days
Study Arms (12)
Low Dose N-Acetyl Cysteine Alone
EXPERIMENTALN-Acetyl Cysteine 600 mg three times daily
Medium Dose N-Acetyl Cysteine
EXPERIMENTALN-Acetyl Cysteine 1,200 mg three times daily
Low Dose N-Acetyl Cysteine and Low Dose Famotidine
EXPERIMENTALN-Acetyl Cysteine 600 mg three times daily Famotidine 20 mg three times daily
High Dose N-Acetyl Cysteine Alone
EXPERIMENTALN-Acetyl Cysteine 1,800 mg three times daily
Medium Dose N-Acetyl Cysteine and Low Dose Famotidine
EXPERIMENTALN-Acetyl Cysteine 1,200 mg three times daily Famotidine 20 mg three times daily
Low Dose N-Acetyl Cysteine and Medium Dose Famotidine
EXPERIMENTALN-Acetyl Cysteine 600 mg three times daily Famotidine 40 mg three times daily
High Dose N-Acetyl Cysteine and Low Dose Famotidine
EXPERIMENTALN-Acetyl Cysteine 1,800 mg three times daily Famotidine 20 mg three times daily
Medium Dose N-Acetyl Cysteine and Medium Dose Famotidine
EXPERIMENTALN-Acetyl Cysteine 1,200 mg three times daily Famotidine 40 mg three times daily
Low Dose N-Acetyl Cysteine and High Dose Famotidine
EXPERIMENTALN-Acetyl Cysteine 600 mg three times daily Famotidine 80 mg three times daily
High Dose N-Acetyl Cysteine and Medium Dose Famotidine
EXPERIMENTALN-Acetyl Cysteine 1,800 mg three times daily Famotidine 40 mg three times daily
Medium Dose N-Acetyl Cysteine and High Dose Famotidine
EXPERIMENTALN-Acetyl Cysteine 1,200 mg three times daily Famotidine 80 mg three times daily
High Dose N-Acetyl Cysteine and High Dose Famotidine
EXPERIMENTALN-Acetyl Cysteine 1,800 mg three times daily Famotidine 80 mg three times daily
Interventions
Oral Famotidine
Oral N-Acetyl Cysteine
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Prisma Health-Upstatelead
- Clemson Universitycollaborator
Study Sites (3)
Prisma Health Baptist Easley Hospital
Easley, South Carolina, 29640, United States
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, 29605, United States
Prisma Health Greer Memorial Hospital
Greer, South Carolina, 29650, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Decrease in COVID-19 infections in the area followed by other treatment options led to to poor enrollment (n=2) and early termination of the study.
Results Point of Contact
- Title
- Dr. Julie Martin - Director, Cancer Research
- Organization
- Prisma Health
Study Officials
- PRINCIPAL INVESTIGATOR
John J O'Connell, M.D.
Prisma Health
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 1, 2020
First Posted
September 10, 2020
Study Start
October 20, 2020
Primary Completion
June 2, 2021
Study Completion
June 2, 2021
Last Updated
February 18, 2022
Results First Posted
February 18, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share