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

• Sponsor: Prisma Health-Upstate (Other)
• Overall Status: Terminated
• CT.gov ID: NCT04545008
• Collaborator: Clemson University (Other)
• Enrollment: 2
• Locations: 3
• Arms: 12
• Actual Duration (Months): 7.4
• Patients Per Site: 0.7
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19	Drug: Famotidine; Drug: N-Acetyl cysteine	Phase 1

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 2 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Oct 20, 2020
• Actual Primary Completion Date: Jun 2, 2021
• Actual Study Completion Date: Jun 2, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Low Dose N-Acetyl Cysteine Alone N-Acetyl Cysteine 600 mg three times daily	Drug: N-Acetyl cysteine; Oral N-Acetyl Cysteine; Other Names: NAC
Experimental: Medium Dose N-Acetyl Cysteine N-Acetyl Cysteine 1,200 mg three times daily	Drug: N-Acetyl cysteine; Oral N-Acetyl Cysteine; Other Names: NAC
Experimental: Low Dose N-Acetyl Cysteine and Low Dose Famotidine N-Acetyl Cysteine 600 mg three times daily Famotidine 20 mg three times daily	Drug: Famotidine; Oral Famotidine; Other Names: Pepcid AC ; Drug: N-Acetyl cysteine; Oral N-Acetyl Cysteine; Other Names: NAC
Experimental: High Dose N-Acetyl Cysteine Alone N-Acetyl Cysteine 1,800 mg three times daily	Drug: N-Acetyl cysteine; Oral N-Acetyl Cysteine; Other Names: NAC
Experimental: Medium Dose N-Acetyl Cysteine and Low Dose Famotidine N-Acetyl Cysteine 1,200 mg three times daily Famotidine 20 mg three times daily	Drug: Famotidine; Oral Famotidine; Other Names: Pepcid AC ; Drug: N-Acetyl cysteine; Oral N-Acetyl Cysteine; Other Names: NAC
Experimental: Low Dose N-Acetyl Cysteine and Medium Dose Famotidine N-Acetyl Cysteine 600 mg three times daily Famotidine 40 mg three times daily	Drug: Famotidine; Oral Famotidine; Other Names: Pepcid AC ; Drug: N-Acetyl cysteine; Oral N-Acetyl Cysteine; Other Names: NAC
Experimental: High Dose N-Acetyl Cysteine and Low Dose Famotidine N-Acetyl Cysteine 1,800 mg three times daily Famotidine 20 mg three times daily	Drug: Famotidine; Oral Famotidine; Other Names: Pepcid AC ; Drug: N-Acetyl cysteine; Oral N-Acetyl Cysteine; Other Names: NAC
Experimental: Medium Dose N-Acetyl Cysteine and Medium Dose Famotidine N-Acetyl Cysteine 1,200 mg three times daily Famotidine 40 mg three times daily	Drug: Famotidine; Oral Famotidine; Other Names: Pepcid AC ; Drug: N-Acetyl cysteine; Oral N-Acetyl Cysteine; Other Names: NAC
Experimental: Low Dose N-Acetyl Cysteine and High Dose Famotidine N-Acetyl Cysteine 600 mg three times daily Famotidine 80 mg three times daily	Drug: Famotidine; Oral Famotidine; Other Names: Pepcid AC ; Drug: N-Acetyl cysteine; Oral N-Acetyl Cysteine; Other Names: NAC
Experimental: High Dose N-Acetyl Cysteine and Medium Dose Famotidine N-Acetyl Cysteine 1,800 mg three times daily Famotidine 40 mg three times daily	Drug: Famotidine; Oral Famotidine; Other Names: Pepcid AC ; Drug: N-Acetyl cysteine; Oral N-Acetyl Cysteine; Other Names: NAC
Experimental: Medium Dose N-Acetyl Cysteine and High Dose Famotidine N-Acetyl Cysteine 1,200 mg three times daily Famotidine 80 mg three times daily	Drug: Famotidine; Oral Famotidine; Other Names: Pepcid AC ; Drug: N-Acetyl cysteine; Oral N-Acetyl Cysteine; Other Names: NAC
Experimental: High Dose N-Acetyl Cysteine and High Dose Famotidine N-Acetyl Cysteine 1,800 mg three times daily Famotidine 80 mg three times daily	Drug: Famotidine; Oral Famotidine; Other Names: Pepcid AC ; Drug: N-Acetyl cysteine; Oral N-Acetyl Cysteine; Other Names: NAC

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0 [0 to 30 days]

   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.

Secondary Outcome Measures

1. Rate of Hospitalization [0 to 30 days]

   Number of participants hospitalized

2. Time to Symptom Resolution [0 to 30 days]

   Days to resolution of symptoms of infection.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Prisma Health Baptist Easley Hospital	Easley	South Carolina	United States	29640
2	Prisma Health Greenville Memorial Hospital	Greenville	South Carolina	United States	29605
3	Prisma Health Greer Memorial Hospital	Greer	South Carolina	United States	29650

Sponsors and Collaborators

• Prisma Health-Upstate
• Clemson University

Investigators

• Principal Investigator: John J O'Connell, M.D., Prisma Health

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 18, 2020

More Information

Publications

None provided.

• Responsible Party: Prisma Health-Upstate
• ClinicalTrials.gov Identifier: NCT04545008
• Other Study ID Numbers: Pro00100394
• First Posted: Sep 10, 2020
• Last Update Posted: Feb 18, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Prisma Health-Upstate: outpatient; famotidine; n-acetyl cysteine
• Additional relevant MeSH terms: COVID-19; Acetylcysteine; Famotidine; N-monoacetylcystine

Study Results

Participant Flow

Arm/Group Title	Low Dose N-Acetyl Cysteine Alone
Arm/Group Description	N-Acetyl Cysteine 600 mg three times daily N-Acetyl cysteine: Oral N-Acetyl Cysteine
Period Title: Overall Study
STARTED	2
COMPLETED	2
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Low Dose N-Acetyl Cysteine Alone
Arm/Group Description	N-Acetyl Cysteine 600 mg three times daily N-Acetyl cysteine: Oral N-Acetyl Cysteine
Overall Participants	2
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	2 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	2 100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 50%
Not Hispanic or Latino	1 50%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	2 100%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	2 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Low Dose N-Acetyl Cysteine Alone
Arm/Group Description	N-Acetyl Cysteine 600 mg three times daily N-Acetyl cysteine: Oral N-Acetyl Cysteine
Measure Participants	2
Number [participants]	0 0%

2. Secondary Outcome

Title	Rate of Hospitalization
Description	Number of participants hospitalized
Time Frame	0 to 30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Low Dose N-Acetyl Cysteine Alone
Arm/Group Description	N-Acetyl Cysteine 600 mg three times daily N-Acetyl cysteine: Oral N-Acetyl Cysteine
Measure Participants	2
Number [participants]	0 0%

3. Secondary Outcome

Title	Time to Symptom Resolution
Description	Days to resolution of symptoms of infection.
Time Frame	0 to 30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Low Dose N-Acetyl Cysteine Alone
Arm/Group Description	N-Acetyl Cysteine 600 mg three times daily N-Acetyl cysteine: Oral N-Acetyl Cysteine
Measure Participants	2
Mean (Full Range) [days]	6

Adverse Events

Time Frame	From consent to study completion, an average of 30 days.
Arm/Group Title	Low Dose N-Acetyl Cysteine Alone
Arm/Group Description	N-Acetyl Cysteine 600 mg three times daily N-Acetyl cysteine: Oral N-Acetyl Cysteine
All Cause Mortality
	Low Dose N-Acetyl Cysteine Alone
	Affected / at Risk (%)	# Events
Total	0/2 (0%)
Serious Adverse Events
	Low Dose N-Acetyl Cysteine Alone
	Affected / at Risk (%)	# Events
Total	0/2 (0%)
Other (Not Including Serious) Adverse Events
	Low Dose N-Acetyl Cysteine Alone
	Affected / at Risk (%)	# Events
Total	0/2 (0%)

Limitations/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.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.