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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04545008
Recruitment Status : Terminated (Study was stopped due to poor accrual.)
First Posted : September 10, 2020
Results First Posted : February 18, 2022
Last Update Posted : February 18, 2022
Sponsor:
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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Low Dose N-Acetyl Cysteine Alone
Hide 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
Arm/Group Title Low Dose N-Acetyl Cysteine Alone
Hide Arm/Group Description

N-Acetyl Cysteine 600 mg three times daily

N-Acetyl cysteine: Oral N-Acetyl Cysteine

Overall Number of Baseline Participants 2
Hide 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
1.Primary Outcome
Title Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose N-Acetyl Cysteine Alone
Hide 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
Hide Description Number of participants hospitalized
Time Frame 0 to 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose N-Acetyl Cysteine Alone
Hide 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
Hide Description Days to resolution of symptoms of infection.
Time Frame 0 to 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose N-Acetyl Cysteine Alone
Hide 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)
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
Hide 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%) 
Hide Serious Adverse Events
Low Dose N-Acetyl Cysteine Alone
Affected / at Risk (%)
Total   0/2 (0.00%) 
Hide 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%) 
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Julie Martin - Director, Cancer Research
Organization: Prisma Health
Phone: 864-455-3667
EMail: julie.martin@prismahealth.org
Layout table for additonal information
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