Trial Outcomes & Findings for Treatment of Long CoronaVirus Disease (COVID) (TLC) Feasibility Trial (NCT NCT05946551)

NCT ID: NCT05946551

Last Updated: 2025-07-17

Results Overview

The number of participants that had any confusion over how to take the study drug, including which pill to take, when to take it, or how many to take will be recorded as part of the end-of-study survey.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 5 participants
• Primary outcome timeframe: End of the Treatment Phase at 12 weeks
• Results posted on: 2025-07-17

Participant Flow

Five participants were recruited from Emory and Grady Healthcare System in Atlanta, Georgia, USA. Participant enrollment began on March 08, 2024, and follow-up for the five participants was complete by June 24, 2024. The study was terminated due to a lack of funding.

Participant milestones

Measure	HRA Treatment Arm Participants randomized to Treatment Arm will receive dual histamine receptor antagonists: famotidine and cetirizine daily. Cetirizine: Cetirizine will be dispensed as a 10mg capsule with instructions for patients to take one capsule daily by mouth, preferably at bedtime. Famotidine: Famotidine will be dispensed in 20mg capsules with instructions for patients to take one capsule twice daily, as close to the same times every day as possible.	Placebo Arm The compounding study pharmacy will provide placebo capsules to the patients randomized to Placebo. These capsules are manufactured to match each treatment drug for oral administration. Cetirizine Placebo: The cetirizine placebo will be designed as a capsule of an inert substance and will match the morphology of the cetirizine treatment capsule. Administration instructions to match that of cetirizine. Famotidine Placebo: The famotidine placebo will be designed as a capsule of an inert substance and will match the morphology of the famotidine treatment capsule. Administration instructions to match that of famotidine.
Overall Study STARTED	3	2
Overall Study COMPLETED	3	2
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatment of Long CoronaVirus Disease (COVID) (TLC) Feasibility Trial

Baseline characteristics by cohort

Measure	HRA Treatment Arm n=3 Participants Participants randomized to Treatment Arm will receive dual histamine receptor antagonists: famotidine and cetirizine daily. Cetirizine: Cetirizine will be dispensed as a 10mg capsule with instructions for patients to take one capsule daily by mouth, preferably at bedtime. Famotidine: Famotidine will be dispensed in 20mg capsules with instructions for patients to take one capsule twice daily, as close to the same times every day as possible.	Placebo Arm n=2 Participants The compounding study pharmacy will provide placebo capsules to the patients randomized to Placebo. These capsules are manufactured to match each treatment drug for oral administration. Cetirizine Placebo: The cetirizine placebo will be designed as a capsule of an inert substance and will match the morphology of the cetirizine treatment capsule. Administration instructions to match that of cetirizine. Famotidine Placebo: The famotidine placebo will be designed as a capsule of an inert substance and will match the morphology of the famotidine treatment capsule. Administration instructions to match that of famotidine.	Total n=5 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	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	1 Participants n=7 Participants	4 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	3 Participants n=5 Participants	2 Participants n=7 Participants	5 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	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 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	3 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants

PRIMARY outcome

Timeframe: End of the Treatment Phase at 12 weeks

The number of participants that had any confusion over how to take the study drug, including which pill to take, when to take it, or how many to take will be recorded as part of the end-of-study survey.

Outcome measures

Measure	HRA Treatment Arm n=3 Participants Participants randomized to Treatment Arm will receive dual histamine receptor antagonists: famotidine and cetirizine daily. Cetirizine: Cetirizine will be dispensed as a 10mg capsule with instructions for patients to take one capsule daily by mouth, preferably at bedtime. Famotidine: Famotidine will be dispensed in 20mg capsules with instructions for patients to take one capsule twice daily, as close to the same times every day as possible.	Placebo Arm n=2 Participants The compounding study pharmacy will provide placebo capsules to the patients randomized to Placebo. These capsules are manufactured to match each treatment drug for oral administration. Cetirizine Placebo: The cetirizine placebo will be designed as a capsule of an inert substance and will match the morphology of the cetirizine treatment capsule. Administration instructions to match that of cetirizine. Famotidine Placebo: The famotidine placebo will be designed as a capsule of an inert substance and will match the morphology of the famotidine treatment capsule. Administration instructions to match that of famotidine.
Number of Participants That Had Any Confusion Over How to Take the Study Drug, Including Which Pill to Take, When to Take it, or How Many to Take	0 Participants	0 Participants

PRIMARY outcome

Timeframe: End of the Treatment Phase at 12 weeks

The number of participants that had trouble adhering to the study drug schedule will be recorded as part of the end-of-study survey.

Outcome measures

Measure	HRA Treatment Arm n=3 Participants Participants randomized to Treatment Arm will receive dual histamine receptor antagonists: famotidine and cetirizine daily. Cetirizine: Cetirizine will be dispensed as a 10mg capsule with instructions for patients to take one capsule daily by mouth, preferably at bedtime. Famotidine: Famotidine will be dispensed in 20mg capsules with instructions for patients to take one capsule twice daily, as close to the same times every day as possible.	Placebo Arm n=2 Participants The compounding study pharmacy will provide placebo capsules to the patients randomized to Placebo. These capsules are manufactured to match each treatment drug for oral administration. Cetirizine Placebo: The cetirizine placebo will be designed as a capsule of an inert substance and will match the morphology of the cetirizine treatment capsule. Administration instructions to match that of cetirizine. Famotidine Placebo: The famotidine placebo will be designed as a capsule of an inert substance and will match the morphology of the famotidine treatment capsule. Administration instructions to match that of famotidine.
Number of Participants That Had Trouble Adhering to the Study Drug Schedule	0 Participants	0 Participants

PRIMARY outcome

Timeframe: End of the Treatment Phase at 12 weeks

The number of participants that had any difficulty using the REDCap interface will be recorded as part of the end-of-study survey.

Outcome measures

Measure	HRA Treatment Arm n=3 Participants Participants randomized to Treatment Arm will receive dual histamine receptor antagonists: famotidine and cetirizine daily. Cetirizine: Cetirizine will be dispensed as a 10mg capsule with instructions for patients to take one capsule daily by mouth, preferably at bedtime. Famotidine: Famotidine will be dispensed in 20mg capsules with instructions for patients to take one capsule twice daily, as close to the same times every day as possible.	Placebo Arm n=2 Participants The compounding study pharmacy will provide placebo capsules to the patients randomized to Placebo. These capsules are manufactured to match each treatment drug for oral administration. Cetirizine Placebo: The cetirizine placebo will be designed as a capsule of an inert substance and will match the morphology of the cetirizine treatment capsule. Administration instructions to match that of cetirizine. Famotidine Placebo: The famotidine placebo will be designed as a capsule of an inert substance and will match the morphology of the famotidine treatment capsule. Administration instructions to match that of famotidine.
Number of Participants That Had Any Difficulty Using the REDCap Interface.	0 Participants	0 Participants

PRIMARY outcome

Timeframe: End of the Treatment Phase at 12 weeks

The number of participants that prefer participating in this virtual study compared to participating in an in-person study hosted at a medical center will be recorded as part of the end-of-study survey.

Outcome measures

Measure	HRA Treatment Arm n=3 Participants Participants randomized to Treatment Arm will receive dual histamine receptor antagonists: famotidine and cetirizine daily. Cetirizine: Cetirizine will be dispensed as a 10mg capsule with instructions for patients to take one capsule daily by mouth, preferably at bedtime. Famotidine: Famotidine will be dispensed in 20mg capsules with instructions for patients to take one capsule twice daily, as close to the same times every day as possible.	Placebo Arm n=2 Participants The compounding study pharmacy will provide placebo capsules to the patients randomized to Placebo. These capsules are manufactured to match each treatment drug for oral administration. Cetirizine Placebo: The cetirizine placebo will be designed as a capsule of an inert substance and will match the morphology of the cetirizine treatment capsule. Administration instructions to match that of cetirizine. Famotidine Placebo: The famotidine placebo will be designed as a capsule of an inert substance and will match the morphology of the famotidine treatment capsule. Administration instructions to match that of famotidine.
Number of Participants That Prefer Participating in This Virtual Study	3 Participants	2 Participants

PRIMARY outcome

Timeframe: End of the Treatment Phase at 12 weeks

The number of participants satisfied with their opportunities to interact with study staff will be recorded as part of the end-of-study survey.

Outcome measures

Measure	HRA Treatment Arm n=3 Participants Participants randomized to Treatment Arm will receive dual histamine receptor antagonists: famotidine and cetirizine daily. Cetirizine: Cetirizine will be dispensed as a 10mg capsule with instructions for patients to take one capsule daily by mouth, preferably at bedtime. Famotidine: Famotidine will be dispensed in 20mg capsules with instructions for patients to take one capsule twice daily, as close to the same times every day as possible.	Placebo Arm n=2 Participants The compounding study pharmacy will provide placebo capsules to the patients randomized to Placebo. These capsules are manufactured to match each treatment drug for oral administration. Cetirizine Placebo: The cetirizine placebo will be designed as a capsule of an inert substance and will match the morphology of the cetirizine treatment capsule. Administration instructions to match that of cetirizine. Famotidine Placebo: The famotidine placebo will be designed as a capsule of an inert substance and will match the morphology of the famotidine treatment capsule. Administration instructions to match that of famotidine.
Number of Participants Satisfied With Their Opportunities to Interact With Study Staff	3 Participants	2 Participants

PRIMARY outcome

Timeframe: End of the Treatment Phase at 12 weeks

The number of participants that felt they could reach study staff if needed will be recorded as part of the end-of-study survey.

Outcome measures

Measure	HRA Treatment Arm n=3 Participants Participants randomized to Treatment Arm will receive dual histamine receptor antagonists: famotidine and cetirizine daily. Cetirizine: Cetirizine will be dispensed as a 10mg capsule with instructions for patients to take one capsule daily by mouth, preferably at bedtime. Famotidine: Famotidine will be dispensed in 20mg capsules with instructions for patients to take one capsule twice daily, as close to the same times every day as possible.	Placebo Arm n=2 Participants The compounding study pharmacy will provide placebo capsules to the patients randomized to Placebo. These capsules are manufactured to match each treatment drug for oral administration. Cetirizine Placebo: The cetirizine placebo will be designed as a capsule of an inert substance and will match the morphology of the cetirizine treatment capsule. Administration instructions to match that of cetirizine. Famotidine Placebo: The famotidine placebo will be designed as a capsule of an inert substance and will match the morphology of the famotidine treatment capsule. Administration instructions to match that of famotidine.
Number of Participants That Felt They Could Reach Study Staff if Needed	3 Participants	2 Participants

PRIMARY outcome

Timeframe: End of the Treatment Phase at 12 weeks

The number of participants that felt that study staff was available and easy to contact to report any adverse effects that they experienced from the medication will be recorded as part of the end-of-study survey.

Outcome measures

Measure	HRA Treatment Arm n=3 Participants Participants randomized to Treatment Arm will receive dual histamine receptor antagonists: famotidine and cetirizine daily. Cetirizine: Cetirizine will be dispensed as a 10mg capsule with instructions for patients to take one capsule daily by mouth, preferably at bedtime. Famotidine: Famotidine will be dispensed in 20mg capsules with instructions for patients to take one capsule twice daily, as close to the same times every day as possible.	Placebo Arm n=2 Participants The compounding study pharmacy will provide placebo capsules to the patients randomized to Placebo. These capsules are manufactured to match each treatment drug for oral administration. Cetirizine Placebo: The cetirizine placebo will be designed as a capsule of an inert substance and will match the morphology of the cetirizine treatment capsule. Administration instructions to match that of cetirizine. Famotidine Placebo: The famotidine placebo will be designed as a capsule of an inert substance and will match the morphology of the famotidine treatment capsule. Administration instructions to match that of famotidine.
Number of Participants That Felt That Study Staff Was Available and Easy to Contact to Report Any Adverse Effects	3 Participants	2 Participants

PRIMARY outcome

Timeframe: End of the Treatment Phase at 12 weeks

The number of participants that felt that the amount of information collected in each series of surveys was acceptable will be recorded as part of the end-of-study survey.

Outcome measures

Measure	HRA Treatment Arm n=3 Participants Participants randomized to Treatment Arm will receive dual histamine receptor antagonists: famotidine and cetirizine daily. Cetirizine: Cetirizine will be dispensed as a 10mg capsule with instructions for patients to take one capsule daily by mouth, preferably at bedtime. Famotidine: Famotidine will be dispensed in 20mg capsules with instructions for patients to take one capsule twice daily, as close to the same times every day as possible.	Placebo Arm n=2 Participants The compounding study pharmacy will provide placebo capsules to the patients randomized to Placebo. These capsules are manufactured to match each treatment drug for oral administration. Cetirizine Placebo: The cetirizine placebo will be designed as a capsule of an inert substance and will match the morphology of the cetirizine treatment capsule. Administration instructions to match that of cetirizine. Famotidine Placebo: The famotidine placebo will be designed as a capsule of an inert substance and will match the morphology of the famotidine treatment capsule. Administration instructions to match that of famotidine.
Number of Participants That Felt That the Amount of Information Collected in Each Series of Surveys Was Acceptable	3 Participants	2 Participants

PRIMARY outcome

Timeframe: End of the Treatment Phase at 12 weeks

The number of participants that felt that the frequency in which the information was collected was acceptable will be recorded as part of the end-of-study survey.

Outcome measures

Measure	HRA Treatment Arm n=3 Participants Participants randomized to Treatment Arm will receive dual histamine receptor antagonists: famotidine and cetirizine daily. Cetirizine: Cetirizine will be dispensed as a 10mg capsule with instructions for patients to take one capsule daily by mouth, preferably at bedtime. Famotidine: Famotidine will be dispensed in 20mg capsules with instructions for patients to take one capsule twice daily, as close to the same times every day as possible.	Placebo Arm n=2 Participants The compounding study pharmacy will provide placebo capsules to the patients randomized to Placebo. These capsules are manufactured to match each treatment drug for oral administration. Cetirizine Placebo: The cetirizine placebo will be designed as a capsule of an inert substance and will match the morphology of the cetirizine treatment capsule. Administration instructions to match that of cetirizine. Famotidine Placebo: The famotidine placebo will be designed as a capsule of an inert substance and will match the morphology of the famotidine treatment capsule. Administration instructions to match that of famotidine.
Number of Participants That Felt That the Frequency in Which the Information Was Collected Was Acceptable	3 Participants	2 Participants

PRIMARY outcome

Timeframe: End of the Treatment Phase at 12 weeks

Participants will be asked how much they feel they improved from this treatment over the last 12 week using a scale from 1 to 5, with 5 being complete improvement (better outcome) and 1 being no improvement.

Outcome measures

Measure	HRA Treatment Arm n=3 Participants Participants randomized to Treatment Arm will receive dual histamine receptor antagonists: famotidine and cetirizine daily. Cetirizine: Cetirizine will be dispensed as a 10mg capsule with instructions for patients to take one capsule daily by mouth, preferably at bedtime. Famotidine: Famotidine will be dispensed in 20mg capsules with instructions for patients to take one capsule twice daily, as close to the same times every day as possible.	Placebo Arm n=2 Participants The compounding study pharmacy will provide placebo capsules to the patients randomized to Placebo. These capsules are manufactured to match each treatment drug for oral administration. Cetirizine Placebo: The cetirizine placebo will be designed as a capsule of an inert substance and will match the morphology of the cetirizine treatment capsule. Administration instructions to match that of cetirizine. Famotidine Placebo: The famotidine placebo will be designed as a capsule of an inert substance and will match the morphology of the famotidine treatment capsule. Administration instructions to match that of famotidine.
Improvement Rating	2.3 Score on a scale Standard Deviation 0.94	2 Score on a scale Standard Deviation 0

PRIMARY outcome

Timeframe: End of the Treatment Phase at 12 weeks

Participants will be asked how much their quality of life was impacted by changes to their health during the study. On a scale of 1 to 5 with 5 being the most impacted (better outcome) and 1 being not at all impacted by changes to their health.

Outcome measures

Measure	HRA Treatment Arm n=3 Participants Participants randomized to Treatment Arm will receive dual histamine receptor antagonists: famotidine and cetirizine daily. Cetirizine: Cetirizine will be dispensed as a 10mg capsule with instructions for patients to take one capsule daily by mouth, preferably at bedtime. Famotidine: Famotidine will be dispensed in 20mg capsules with instructions for patients to take one capsule twice daily, as close to the same times every day as possible.	Placebo Arm n=2 Participants The compounding study pharmacy will provide placebo capsules to the patients randomized to Placebo. These capsules are manufactured to match each treatment drug for oral administration. Cetirizine Placebo: The cetirizine placebo will be designed as a capsule of an inert substance and will match the morphology of the cetirizine treatment capsule. Administration instructions to match that of cetirizine. Famotidine Placebo: The famotidine placebo will be designed as a capsule of an inert substance and will match the morphology of the famotidine treatment capsule. Administration instructions to match that of famotidine.
Quality of Life (QoL) Score Rating	2 Score on a scale Standard Deviation 1.4	1.5 Score on a scale Standard Deviation 0.5

PRIMARY outcome

Timeframe: End of the Treatment Phase at 12 weeks

Participants will be asked how interested they are in continuing treatment with the study medication after the study. On a scale of 1 to 5, with 5 being completely interested (better outcome) and 1 being completely uninterested.

Outcome measures

Measure	HRA Treatment Arm n=3 Participants Participants randomized to Treatment Arm will receive dual histamine receptor antagonists: famotidine and cetirizine daily. Cetirizine: Cetirizine will be dispensed as a 10mg capsule with instructions for patients to take one capsule daily by mouth, preferably at bedtime. Famotidine: Famotidine will be dispensed in 20mg capsules with instructions for patients to take one capsule twice daily, as close to the same times every day as possible.	Placebo Arm n=2 Participants The compounding study pharmacy will provide placebo capsules to the patients randomized to Placebo. These capsules are manufactured to match each treatment drug for oral administration. Cetirizine Placebo: The cetirizine placebo will be designed as a capsule of an inert substance and will match the morphology of the cetirizine treatment capsule. Administration instructions to match that of cetirizine. Famotidine Placebo: The famotidine placebo will be designed as a capsule of an inert substance and will match the morphology of the famotidine treatment capsule. Administration instructions to match that of famotidine.
Interest Score	4.3 score on a scale Standard Deviation 0.94	3 score on a scale Standard Deviation 2

SECONDARY outcome

Timeframe: End of the Treatment Phase at 12 weeks

Percentage of participants who complete 70% of surveys will be assessed

Outcome measures

Measure	HRA Treatment Arm n=3 Participants Participants randomized to Treatment Arm will receive dual histamine receptor antagonists: famotidine and cetirizine daily. Cetirizine: Cetirizine will be dispensed as a 10mg capsule with instructions for patients to take one capsule daily by mouth, preferably at bedtime. Famotidine: Famotidine will be dispensed in 20mg capsules with instructions for patients to take one capsule twice daily, as close to the same times every day as possible.	Placebo Arm n=2 Participants The compounding study pharmacy will provide placebo capsules to the patients randomized to Placebo. These capsules are manufactured to match each treatment drug for oral administration. Cetirizine Placebo: The cetirizine placebo will be designed as a capsule of an inert substance and will match the morphology of the cetirizine treatment capsule. Administration instructions to match that of cetirizine. Famotidine Placebo: The famotidine placebo will be designed as a capsule of an inert substance and will match the morphology of the famotidine treatment capsule. Administration instructions to match that of famotidine.
Proportion of Survey Completion	3 Participants	2 Participants

SECONDARY outcome

Timeframe: End of the Treatment Phase at 12 weeks

Percentage of participants who complete 70% of doses will be assessed

Outcome measures

Measure	HRA Treatment Arm n=3 Participants Participants randomized to Treatment Arm will receive dual histamine receptor antagonists: famotidine and cetirizine daily. Cetirizine: Cetirizine will be dispensed as a 10mg capsule with instructions for patients to take one capsule daily by mouth, preferably at bedtime. Famotidine: Famotidine will be dispensed in 20mg capsules with instructions for patients to take one capsule twice daily, as close to the same times every day as possible.	Placebo Arm n=2 Participants The compounding study pharmacy will provide placebo capsules to the patients randomized to Placebo. These capsules are manufactured to match each treatment drug for oral administration. Cetirizine Placebo: The cetirizine placebo will be designed as a capsule of an inert substance and will match the morphology of the cetirizine treatment capsule. Administration instructions to match that of cetirizine. Famotidine Placebo: The famotidine placebo will be designed as a capsule of an inert substance and will match the morphology of the famotidine treatment capsule. Administration instructions to match that of famotidine.
Proportion of Study Drug Adherence	3 Participants	2 Participants

SECONDARY outcome

Timeframe: End of the Treatment Phase at 12 weeks

Percentage of participants Lost to Follow Up (LFUP) will be assessed

Outcome measures

Measure	HRA Treatment Arm n=3 Participants Participants randomized to Treatment Arm will receive dual histamine receptor antagonists: famotidine and cetirizine daily. Cetirizine: Cetirizine will be dispensed as a 10mg capsule with instructions for patients to take one capsule daily by mouth, preferably at bedtime. Famotidine: Famotidine will be dispensed in 20mg capsules with instructions for patients to take one capsule twice daily, as close to the same times every day as possible.	Placebo Arm n=2 Participants The compounding study pharmacy will provide placebo capsules to the patients randomized to Placebo. These capsules are manufactured to match each treatment drug for oral administration. Cetirizine Placebo: The cetirizine placebo will be designed as a capsule of an inert substance and will match the morphology of the cetirizine treatment capsule. Administration instructions to match that of cetirizine. Famotidine Placebo: The famotidine placebo will be designed as a capsule of an inert substance and will match the morphology of the famotidine treatment capsule. Administration instructions to match that of famotidine.
Proportion of Lost to Follow Up (LFUP)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: End of the Treatment Phase at 12 weeks

Percentage of participants that voluntarily terminate participation will be assessed

Outcome measures

Measure	HRA Treatment Arm n=3 Participants Participants randomized to Treatment Arm will receive dual histamine receptor antagonists: famotidine and cetirizine daily. Cetirizine: Cetirizine will be dispensed as a 10mg capsule with instructions for patients to take one capsule daily by mouth, preferably at bedtime. Famotidine: Famotidine will be dispensed in 20mg capsules with instructions for patients to take one capsule twice daily, as close to the same times every day as possible.	Placebo Arm n=2 Participants The compounding study pharmacy will provide placebo capsules to the patients randomized to Placebo. These capsules are manufactured to match each treatment drug for oral administration. Cetirizine Placebo: The cetirizine placebo will be designed as a capsule of an inert substance and will match the morphology of the cetirizine treatment capsule. Administration instructions to match that of cetirizine. Famotidine Placebo: The famotidine placebo will be designed as a capsule of an inert substance and will match the morphology of the famotidine treatment capsule. Administration instructions to match that of famotidine.
Proportion of Voluntary Termination	0 Participants	0 Participants

SECONDARY outcome

Timeframe: End of the Treatment Phase at 12 weeks

The mean number of adverse events in the treatment arms will be compared to those in the placebo arm.

Outcome measures

Measure	HRA Treatment Arm n=3 Participants Participants randomized to Treatment Arm will receive dual histamine receptor antagonists: famotidine and cetirizine daily. Cetirizine: Cetirizine will be dispensed as a 10mg capsule with instructions for patients to take one capsule daily by mouth, preferably at bedtime. Famotidine: Famotidine will be dispensed in 20mg capsules with instructions for patients to take one capsule twice daily, as close to the same times every day as possible.	Placebo Arm n=2 Participants The compounding study pharmacy will provide placebo capsules to the patients randomized to Placebo. These capsules are manufactured to match each treatment drug for oral administration. Cetirizine Placebo: The cetirizine placebo will be designed as a capsule of an inert substance and will match the morphology of the cetirizine treatment capsule. Administration instructions to match that of cetirizine. Famotidine Placebo: The famotidine placebo will be designed as a capsule of an inert substance and will match the morphology of the famotidine treatment capsule. Administration instructions to match that of famotidine.
Adverse Events (AEs) Incidence	3.7 number of adverse events Standard Deviation 1.2	2 number of adverse events Standard Deviation 1

SECONDARY outcome

Timeframe: End of the Treatment Phase at 12 weeks

The number of SUSARs in the treatment arms versus the placebo arm will be recorded.

Outcome measures

Measure	HRA Treatment Arm n=3 Participants Participants randomized to Treatment Arm will receive dual histamine receptor antagonists: famotidine and cetirizine daily. Cetirizine: Cetirizine will be dispensed as a 10mg capsule with instructions for patients to take one capsule daily by mouth, preferably at bedtime. Famotidine: Famotidine will be dispensed in 20mg capsules with instructions for patients to take one capsule twice daily, as close to the same times every day as possible.	Placebo Arm n=2 Participants The compounding study pharmacy will provide placebo capsules to the patients randomized to Placebo. These capsules are manufactured to match each treatment drug for oral administration. Cetirizine Placebo: The cetirizine placebo will be designed as a capsule of an inert substance and will match the morphology of the cetirizine treatment capsule. Administration instructions to match that of cetirizine. Famotidine Placebo: The famotidine placebo will be designed as a capsule of an inert substance and will match the morphology of the famotidine treatment capsule. Administration instructions to match that of famotidine.
Serious, Unexpected Suspected Adverse Reactions (SUSAR) Incidence	0 Number of SUSARs	0 Number of SUSARs

SECONDARY outcome

Timeframe: End of the Treatment Phase at 12 weeks

The total number of SAEs in the treatment arms versus the placebo arm will be recorded.

Outcome measures

Measure	HRA Treatment Arm n=3 Participants Participants randomized to Treatment Arm will receive dual histamine receptor antagonists: famotidine and cetirizine daily. Cetirizine: Cetirizine will be dispensed as a 10mg capsule with instructions for patients to take one capsule daily by mouth, preferably at bedtime. Famotidine: Famotidine will be dispensed in 20mg capsules with instructions for patients to take one capsule twice daily, as close to the same times every day as possible.	Placebo Arm n=2 Participants The compounding study pharmacy will provide placebo capsules to the patients randomized to Placebo. These capsules are manufactured to match each treatment drug for oral administration. Cetirizine Placebo: The cetirizine placebo will be designed as a capsule of an inert substance and will match the morphology of the cetirizine treatment capsule. Administration instructions to match that of cetirizine. Famotidine Placebo: The famotidine placebo will be designed as a capsule of an inert substance and will match the morphology of the famotidine treatment capsule. Administration instructions to match that of famotidine.
Study-wide Serious Adverse Events (SAEs) Incidence	0 Number of SAEs	0 Number of SAEs

SECONDARY outcome

Timeframe: End of the Treatment Phase at 12 weeks

The total number of participants who discontinue any of the treatment arms versus the placebo arm will be recorded.

Outcome measures

Measure	HRA Treatment Arm n=3 Participants Participants randomized to Treatment Arm will receive dual histamine receptor antagonists: famotidine and cetirizine daily. Cetirizine: Cetirizine will be dispensed as a 10mg capsule with instructions for patients to take one capsule daily by mouth, preferably at bedtime. Famotidine: Famotidine will be dispensed in 20mg capsules with instructions for patients to take one capsule twice daily, as close to the same times every day as possible.	Placebo Arm n=2 Participants The compounding study pharmacy will provide placebo capsules to the patients randomized to Placebo. These capsules are manufactured to match each treatment drug for oral administration. Cetirizine Placebo: The cetirizine placebo will be designed as a capsule of an inert substance and will match the morphology of the cetirizine treatment capsule. Administration instructions to match that of cetirizine. Famotidine Placebo: The famotidine placebo will be designed as a capsule of an inert substance and will match the morphology of the famotidine treatment capsule. Administration instructions to match that of famotidine.
Number of Discontinuations or Temporary Suspensions of IP	0 Participants	0 Participants

Adverse Events

HRA Treatment Arm

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo Arm

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	HRA Treatment Arm n=3 participants at risk Participants randomized to Treatment Arm will receive dual histamine receptor antagonists: famotidine and cetirizine daily. Cetirizine: Cetirizine will be dispensed as a 10mg capsule with instructions for patients to take one capsule daily by mouth, preferably at bedtime. Famotidine: Famotidine will be dispensed in 20mg capsules with instructions for patients to take one capsule twice daily, as close to the same times every day as possible.	Placebo Arm n=2 participants at risk The compounding study pharmacy will provide placebo capsules to the patients randomized to Placebo. These capsules are manufactured to match each treatment drug for oral administration. Cetirizine Placebo: The cetirizine placebo will be designed as a capsule of an inert substance and will match the morphology of the cetirizine treatment capsule. Administration instructions to match that of cetirizine. Famotidine Placebo: The famotidine placebo will be designed as a capsule of an inert substance and will match the morphology of the famotidine treatment capsule. Administration instructions to match that of famotidine.
Musculoskeletal and connective tissue disorders Sore neck	33.3% 1/3 • Information on adverse events, Serious Adverse Effects were assessed after randomization until completion of the study (12 weeks post-intervention).	0.00% 0/2 • Information on adverse events, Serious Adverse Effects were assessed after randomization until completion of the study (12 weeks post-intervention).
Respiratory, thoracic and mediastinal disorders Upper respiratory infection	66.7% 2/3 • Information on adverse events, Serious Adverse Effects were assessed after randomization until completion of the study (12 weeks post-intervention).	100.0% 2/2 • Information on adverse events, Serious Adverse Effects were assessed after randomization until completion of the study (12 weeks post-intervention).
Infections and infestations Herpes Zoster	33.3% 1/3 • Information on adverse events, Serious Adverse Effects were assessed after randomization until completion of the study (12 weeks post-intervention).	0.00% 0/2 • Information on adverse events, Serious Adverse Effects were assessed after randomization until completion of the study (12 weeks post-intervention).

Additional Information

Tiffany Walker, MD Assistant Professor

Emory University

Phone: 404-778-1621

Email: tiffany.austin.walker@emory.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place