Trial Outcomes & Findings for Leidos-Enabled Adaptive Protocol (LEAP-CT) for Evaluation of Post-exposure Prophylaxis for Newly-infected COVID-19 Patients (NCT NCT05077969)
NCT ID: NCT05077969
Last Updated: 2024-07-09
Results Overview
Medically attended contact will be measured in whole numbers and reported as "1 medically attended contact" each time, in the electronic data capture system for all study participants.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
4 participants
Primary outcome timeframe
Through Day 30
Results posted on
2024-07-09
Participant Flow
While 9 patients were randomized into the study only 4 patients received study drug due to early termination of the study.
Participant milestones
| Measure |
Group 1 (Study Product)
Participants will receive 80 mg famotidine (PO) QID and 400 mg celecoxib as a first dose, followed by 200 mg (PO) BID celecoxib, for 5 days. Following this 5-day period, participants will continue their famotidine treatment for an additional 9 days.
Famotidine: 80 mg tablet, QID for 14 days
Celecoxib: 400 mg (initial dose), then 200 mg capsule, BID for 5 days
|
Group 2 (Reference Therapy)
Participants will receive matching placebos QID and BID, for 5 days. Following this 5-day period, participants will continue to receive matching famotidine placebo, QID, for an additional 9 days.
Placebo: tablet, QID for 14 days; capsule, BID for 5 days
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
|
Overall Study
COMPLETED
|
1
|
2
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Leidos-Enabled Adaptive Protocol (LEAP-CT) for Evaluation of Post-exposure Prophylaxis for Newly-infected COVID-19 Patients
Baseline characteristics by cohort
| Measure |
Group 1 (Study Product)
n=2 Participants
Participants will receive 80 mg famotidine (PO) QID and 400 mg celecoxib as a first dose, followed by 200 mg (PO) BID celecoxib, for 5 days. Following this 5-day period, participants will continue their famotidine treatment for an additional 9 days.
Famotidine: 80 mg tablet, QID for 14 days
Celecoxib: 400 mg (initial dose), then 200 mg capsule, BID for 5 days
|
Group 2 (Reference Therapy)
n=2 Participants
Participants will receive matching placebos QID and BID, for 5 days. Following this 5-day period, participants will continue to receive matching famotidine placebo, QID, for an additional 9 days.
Placebo: tablet, QID for 14 days; capsule, BID for 5 days
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
42.5 years
n=5 Participants
|
27 years
n=7 Participants
|
34.75 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Through Day 30Medically attended contact will be measured in whole numbers and reported as "1 medically attended contact" each time, in the electronic data capture system for all study participants.
Outcome measures
| Measure |
Group 1 (Study Product)
n=1 Participants
Participants will receive 80 mg famotidine (PO) QID and 400 mg celecoxib as a first dose, followed by 200 mg (PO) BID celecoxib, for 5 days. Following this 5-day period, participants will continue their famotidine treatment for an additional 9 days.
Famotidine: 80 mg tablet, QID for 14 days
Celecoxib: 400 mg (initial dose), then 200 mg capsule, BID for 5 days
|
Group 2 (Reference Therapy)
n=2 Participants
Participants will receive matching placebos QID and BID, for 5 days. Following this 5-day period, participants will continue to receive matching famotidine placebo, QID, for an additional 9 days.
Placebo: tablet, QID for 14 days; capsule, BID for 5 days
|
|---|---|---|
|
Number of Patients With at Least One COVID-19-related Medically Attended Contact Due to Increased COVID-19 Symptom Severity
|
1 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Through Day 30Population: Participants were all white (non-Hispanic) females between 18 and 65 years of age.
Medically attended contact will be measured in whole numbers and reported as "1 medically attended contact" in the electronic data capture system for all study participants.
Outcome measures
| Measure |
Group 1 (Study Product)
n=1 Participants
Participants will receive 80 mg famotidine (PO) QID and 400 mg celecoxib as a first dose, followed by 200 mg (PO) BID celecoxib, for 5 days. Following this 5-day period, participants will continue their famotidine treatment for an additional 9 days.
Famotidine: 80 mg tablet, QID for 14 days
Celecoxib: 400 mg (initial dose), then 200 mg capsule, BID for 5 days
|
Group 2 (Reference Therapy)
n=2 Participants
Participants will receive matching placebos QID and BID, for 5 days. Following this 5-day period, participants will continue to receive matching famotidine placebo, QID, for an additional 9 days.
Placebo: tablet, QID for 14 days; capsule, BID for 5 days
|
|---|---|---|
|
Number of Patients With at Least One COVID-19-related Medically Attended Contact Due to Death (All-cause Mortality).
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 90 daysPopulation: Participants were all white (non-Hispanic) females between 18 and 65 years of age.
Study discontinuation will be measured in whole units, by number of participants who are removed with the reason of "SAE" and captured by the electronic data capture system.
Outcome measures
| Measure |
Group 1 (Study Product)
n=1 Participants
Participants will receive 80 mg famotidine (PO) QID and 400 mg celecoxib as a first dose, followed by 200 mg (PO) BID celecoxib, for 5 days. Following this 5-day period, participants will continue their famotidine treatment for an additional 9 days.
Famotidine: 80 mg tablet, QID for 14 days
Celecoxib: 400 mg (initial dose), then 200 mg capsule, BID for 5 days
|
Group 2 (Reference Therapy)
n=2 Participants
Participants will receive matching placebos QID and BID, for 5 days. Following this 5-day period, participants will continue to receive matching famotidine placebo, QID, for an additional 9 days.
Placebo: tablet, QID for 14 days; capsule, BID for 5 days
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Serious Adverse Events (SAE) as Assessed by Participant Withdrawal
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 90 daysPopulation: Participants were all white (non-Hispanic) females between 18 and 65 years of age.
Deaths will be captured by whole numbers, by number of participants who are removed from the study with reason as "death" in the electronic data capture system.
Outcome measures
| Measure |
Group 1 (Study Product)
n=1 Participants
Participants will receive 80 mg famotidine (PO) QID and 400 mg celecoxib as a first dose, followed by 200 mg (PO) BID celecoxib, for 5 days. Following this 5-day period, participants will continue their famotidine treatment for an additional 9 days.
Famotidine: 80 mg tablet, QID for 14 days
Celecoxib: 400 mg (initial dose), then 200 mg capsule, BID for 5 days
|
Group 2 (Reference Therapy)
n=2 Participants
Participants will receive matching placebos QID and BID, for 5 days. Following this 5-day period, participants will continue to receive matching famotidine placebo, QID, for an additional 9 days.
Placebo: tablet, QID for 14 days; capsule, BID for 5 days
|
|---|---|---|
|
Incidence of Death
|
0 Participants
|
0 Participants
|
Adverse Events
Group 1 (Study Product)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Group 2 (Reference Therapy)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1 (Study Product)
n=2 participants at risk
Participants will receive 80 mg famotidine (PO) QID and 400 mg celecoxib as a first dose, followed by 200 mg (PO) BID celecoxib, for 5 days. Following this 5-day period, participants will continue their famotidine treatment for an additional 9 days.
Famotidine: 80 mg tablet, QID for 14 days
Celecoxib: 400 mg (initial dose), then 200 mg capsule, BID for 5 days
|
Group 2 (Reference Therapy)
n=2 participants at risk
Participants will receive matching placebos QID and BID, for 5 days. Following this 5-day period, participants will continue to receive matching famotidine placebo, QID, for an additional 9 days.
Placebo: tablet, QID for 14 days; capsule, BID for 5 days
|
|---|---|---|
|
Nervous system disorders
Sinus Headaches
|
50.0%
1/2 • 90 days
|
0.00%
0/2 • 90 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place