Trial Outcomes & Findings for Trial of Famotidine & N-Acetyl Cysteine for Outpatients With COVID-19 (NCT NCT04545008)

Last Updated: 2022-02-18

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

2 participants

Primary outcome timeframe

0 to 30 days

Results posted on

2022-02-18

Participant Flow

Participant milestones

Participant milestones
Measure	Low Dose N-Acetyl Cysteine Alone N-Acetyl Cysteine 600 mg three times daily N-Acetyl cysteine: Oral N-Acetyl Cysteine
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Low Dose N-Acetyl Cysteine Alone n=2 Participants N-Acetyl Cysteine 600 mg three times daily N-Acetyl cysteine: Oral N-Acetyl Cysteine
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants

PRIMARY outcome

Timeframe: 0 to 30 days

Outcome measures

Outcome measures
Measure	Low Dose N-Acetyl Cysteine Alone n=2 Participants N-Acetyl Cysteine 600 mg three times daily N-Acetyl cysteine: Oral N-Acetyl Cysteine
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v5.0	0 participants

SECONDARY outcome

Timeframe: 0 to 30 days

Number of participants hospitalized

Outcome measures

Outcome measures
Measure	Low Dose N-Acetyl Cysteine Alone n=2 Participants N-Acetyl Cysteine 600 mg three times daily N-Acetyl cysteine: Oral N-Acetyl Cysteine
Rate of Hospitalization	0 participants

SECONDARY outcome

Timeframe: 0 to 30 days

Days to resolution of symptoms of infection.

Outcome measures

Outcome measures
Measure	Low Dose N-Acetyl Cysteine Alone n=2 Participants N-Acetyl Cysteine 600 mg three times daily N-Acetyl cysteine: Oral N-Acetyl Cysteine
Time to Symptom Resolution	6 days Interval 6.0 to 6.0

Adverse Events

Low Dose N-Acetyl Cysteine Alone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Julie Martin - Director, Cancer Research

Prisma Health

Phone: 864-455-3667

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place