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

• ClinicalTrials.gov Identifier: NCT04545008
• Recruitment Status: Terminated
• First Posted: September 10, 2020
• Results First Posted: February 18, 2022
• Last Update Posted: February 18, 2022
• Sponsor: Prisma Health-Upstate
• Collaborator: Clemson University
• Information provided by (Responsible Party): Prisma Health-Upstate

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Covid19
• Interventions: Drug: Famotidine; Drug: N-Acetyl cysteine
• Enrollment: 2

Participant Flow

Recruitment Details
Pre-assignment Details

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 Number of Baseline Participants		2
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	2 participants
	<=18 years	0 0.0%
	Between 18 and 65 years	2 100.0%
	>=65 years	0 0.0%
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	2 participants
	Female	0 0.0%
	Male	2 100.0%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	2 participants
	Hispanic or Latino	1 50.0%
	Not Hispanic or Latino	1 50.0%
	Unknown or Not Reported	0 0.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	2 participants
	American Indian or Alaska Native	0 0.0%
	Asian	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%
	Black or African American	0 0.0%
	White	2 100.0%
	More than one race	0 0.0%
	Unknown or Not Reported	0 0.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	2 participants
		2

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
Overall Number of Participants Analyzed	2
Measure Type: Number; Unit of Measure: participants
	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
Overall Number of Participants Analyzed	2
Measure Type: Number; Unit of Measure: participants
	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
Overall Number of Participants Analyzed	2
Mean (Full Range); Unit of Measure: days
	6; (6 to 6)

Adverse Events

Time Frame	From consent to study completion, an average of 30 days.
Adverse Event Reporting 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
All-Cause Mortality
	Low Dose N-Acetyl Cysteine Alone
	Affected / at Risk (%)
Total	0/2 (0.00%)
Serious Adverse Events
	Low Dose N-Acetyl Cysteine Alone
	Affected / at Risk (%)
Total	0/2 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Low Dose N-Acetyl Cysteine Alone
	Affected / at Risk (%)
Total	0/2 (0.00%)

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.

More Information

Certain Agreements

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

Results Point of Contact

• Name/Title: Dr. Julie Martin - Director, Cancer Research
• Organization: Prisma Health
• Phone: 864-455-3667
• EMail: julie.martin@prismahealth.org

• Responsible Party: Prisma Health-Upstate
• ClinicalTrials.gov Identifier: NCT04545008
• Other Study ID Numbers: Pro00100394
• First Submitted: September 1, 2020
• First Posted: September 10, 2020
• Results First Submitted: February 4, 2022
• Results First Posted: February 18, 2022
• Last Update Posted: February 18, 2022