Trial Outcomes & Findings for Famotidine vs Placebo for the Treatment of Non-Hospitalized Adults With COVID-19 (NCT NCT04724720)
NCT ID: NCT04724720
Last Updated: 2026-06-15
Results Overview
Measured by the cumulative incidence of symptom resolution using the "COVID-19 Symptom Score" derived from the answers to a questionnaire based on the NIH endorsed guidelines and the recent FDA guidelines for studying COVID-19 in an outpatient setting. A shorter version has been utilized as a scoring system in the case series of famotidine use in non-hospitalized patients with COVID-19.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
56 participants
Primary outcome timeframe
Day 28
Results posted on
2026-06-15
Participant Flow
Participant milestones
| Measure |
Famotidine
Participants in this study arm will receive standard of care and prescribed famotidine at 80mg TID for a maximum of 14 days, or until hospital admission.
Famotidine: Standard or care treatment plus prescribed famotidine
|
Placebo
Participants in this study arm will receive standard of care and placebo for a maximum of 14 days.
Placebo: Standard of care treatment plus placebo
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
28
|
|
Overall Study
COMPLETED
|
27
|
28
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Famotidine
Participants in this study arm will receive standard of care and prescribed famotidine at 80mg TID for a maximum of 14 days, or until hospital admission.
Famotidine: Standard or care treatment plus prescribed famotidine
|
Placebo
Participants in this study arm will receive standard of care and placebo for a maximum of 14 days.
Placebo: Standard of care treatment plus placebo
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Famotidine vs Placebo for the Treatment of Non-Hospitalized Adults With COVID-19
Baseline characteristics by cohort
| Measure |
Famotidine
n=27 Participants
Participants in this study arm will receive standard of care and prescribed famotidine at 80mg TID for a maximum of 14 days, or until hospital admission.
Famotidine: Standard or care treatment plus prescribed famotidine
|
Placebo
n=28 Participants
Participants in this study arm will receive standard of care and placebo for a maximum of 14 days.
Placebo: Standard of care treatment plus placebo
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=20 Participants
|
28 Participants
n=20 Participants
|
55 Participants
n=40 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Age, Continuous
|
35 years
n=20 Participants
|
31.5 years
n=20 Participants
|
35 years
n=40 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=20 Participants
|
18 Participants
n=20 Participants
|
35 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
20 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=20 Participants
|
7 Participants
n=20 Participants
|
12 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
18 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
22 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
27 Participants
n=20 Participants
|
28 Participants
n=20 Participants
|
55 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Day 28Measured by the cumulative incidence of symptom resolution using the "COVID-19 Symptom Score" derived from the answers to a questionnaire based on the NIH endorsed guidelines and the recent FDA guidelines for studying COVID-19 in an outpatient setting. A shorter version has been utilized as a scoring system in the case series of famotidine use in non-hospitalized patients with COVID-19.
Outcome measures
| Measure |
Famotidine
n=27 Participants
Patients receiving study medication for 14 days.
|
Placebo
n=28 Participants
Patients receiving placebo for 14 days.
|
|---|---|---|
|
Number of Participants With Symptom Resolution
|
14 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: Day 28Assessed by modelling the resolution of cumulative symptoms over time using a mixed random effect model with co-variant adjustment.
Outcome measures
| Measure |
Famotidine
n=27 Participants
Patients receiving study medication for 14 days.
|
Placebo
n=28 Participants
Patients receiving placebo for 14 days.
|
|---|---|---|
|
Time to Symptom Resolution in Days
|
8.2 Days
Interval 7.0 to 9.8
|
11.4 Days
Interval 10.3 to 12.6
|
SECONDARY outcome
Timeframe: Day 60Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
Outcome measures
| Measure |
Famotidine
n=27 Participants
Patients receiving study medication for 14 days.
|
Placebo
n=28 Participants
Patients receiving placebo for 14 days.
|
|---|---|---|
|
Assessment of Serious Adverse Events
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 7ferritin \[microg/L\]
Outcome measures
| Measure |
Famotidine
n=27 Participants
Patients receiving study medication for 14 days.
|
Placebo
n=28 Participants
Patients receiving placebo for 14 days.
|
|---|---|---|
|
Change in Ferritin
|
0.13 micrograms/L
Interval -0.02 to 0.29
|
0.21 micrograms/L
Interval 0.05 to 0.38
|
Adverse Events
Famotidine
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Famotidine
n=27 participants at risk
Participants in this study arm will receive standard of care and prescribed famotidine at 80mg TID for a maximum of 14 days, or until hospital admission.
Famotidine: Standard or care treatment plus prescribed famotidine
|
Placebo
n=28 participants at risk
Participants in this study arm will receive standard of care and placebo for a maximum of 14 days.
Placebo: Standard of care treatment plus placebo
|
|---|---|---|
|
Hepatobiliary disorders
elevated liver function tests
|
7.4%
2/27 • Number of events 2 • 60 days
|
7.1%
2/28 • Number of events 2 • 60 days
|
|
Gastrointestinal disorders
nausea
|
3.7%
1/27 • Number of events 1 • 60 days
|
0.00%
0/28 • 60 days
|
|
Blood and lymphatic system disorders
thrombocytopenia
|
0.00%
0/27 • 60 days
|
3.6%
1/28 • Number of events 1 • 60 days
|
|
Skin and subcutaneous tissue disorders
hives
|
0.00%
0/27 • 60 days
|
3.6%
1/28 • Number of events 1 • 60 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place