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Study was terminated due to lack of funding.
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| Name | Class |
|---|---|
| CURE Drug Repurposing Collaboratory (CDRC) | UNKNOWN |
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The primary objective of this study is to assess the feasibility and acceptability of methods and procedures to be employed in a larger scale decentralized platform adaptive randomized clinical trial in patients with a history of a Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Polymerase Chain Reaction (PCR) positive test and/or medical records from a healthcare provider that coincides with the diagnosis of long-COVID.
Fully decentralized single-center, double-blind, randomized, placebo-controlled pilot feasibility trial for patients reporting symptoms consistent with at least one of the following PASC symptoms: Brain fog, Fatigue, Headache, Sleep Disturbance, Post-exertional Malaise (PEM), or Dysautonomia.
Participants' interactions with study staff and the study visits will occur primarily via REDCap and Zoom. Informed consent will be conducted remotely via Zoom and obtained electronically in REDCap. Subjects will complete protocol-required logs, questionnaires, and surveys in REDCap. Dose tolerability assessments will occur via televisit preferably, or phone if necessary.
Following informed consent, subjects will enter a 4-week screening period during which medical records will be obtained and reviewed. At baseline (Day -28) subjects will complete a battery of tests consisting of the World Health Organization Disability Assessment Schedule (WHODAS) 2.0, Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue 7a, Insomnia Severity Scale, PROMIS Cognitive Function 6A, DePaul Symptom Questionnaire - Post-Exertional Malaise (DSQ-PEM) Short Form, Headache Diary, COMPASS 31, and Self-reported persistent symptoms questionnaire. The headache diary requires daily tracking for 7 days (i.e., Day -28- Day -22).
Subjects who complete the screening phase will proceed to randomization where they will be randomized 2:1 to either histamine receptor antagonists (cetirizine and famotidine) or matching placebos. Emory University's Investigational Drug Services (IDS) will conduct the randomization and will overnight via national courier the assigned medication to the study subject. The treatment phase of 12 weeks starts upon ingestion of the first dose.
Cetirizine and famotidine will be supplied as 10mg capsules and 20mg capsules respectively. Dosing for the entire treatment period is one 10mg capsule cetirizine or placebo once daily, preferably at bedtime, and one 20mg capsule famotidine or placebo twice daily, as near as possible to the same time every day. Dose tolerability will be assessed on Day 14 via televisit or phone call. If the dose of either IP is not tolerated, subjects will be removed from the study. If the doses are tolerated, subjects will be resupplied and tolerability assessed per protocol.
Throughout the treatment phase subjects in all arms will complete the symptom questionnaire, adverse event, study drug adherence, and concomitant medication logs weekly. All subjects will complete the full battery of tests on Days 42, 63, and 84 (Weeks 6, 9, and 12). Subjects will have a +/- 3-day window in which to complete the battery. However, the headache diary requires daily tracking for the 7 days preceding Days 43, 63, and 84. On Day 84 all subjects will complete an end-of-study survey assessing their thoughts and feelings about the study methods and procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRA Treatment Arm | Experimental | Participants randomized to Treatment Arm will receive dual histamine receptor antagonists: famotidine and cetirizine daily. |
|
| Placebo Arm | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cetirizine | Drug | Cetirizine will be dispensed as a 10mg capsule with instructions for patients to take one capsule daily by mouth, preferably at bedtime. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | End of the Treatment Phase at 12 weeks |
| Number of Participants That Had Trouble Adhering to the Study Drug Schedule | The number of participants that had trouble adhering to the study drug schedule will be recorded as part of the end-of-study survey. | End of the Treatment Phase at 12 weeks |
| Number of Participants That Had Any Difficulty Using the REDCap Interface. | The number of participants that had any difficulty using the REDCap interface will be recorded as part of the end-of-study survey. | End of the Treatment Phase at 12 weeks |
| Number of Participants That Prefer Participating in This Virtual Study | 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. | End of the Treatment Phase at 12 weeks |
| Number of Participants Satisfied With Their Opportunities to Interact With Study Staff | The number of participants satisfied with their opportunities to interact with study staff will be recorded as part of the end-of-study survey. | End of the Treatment Phase at 12 weeks |
| Number of Participants That Felt They Could Reach Study Staff if Needed |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Survey Completion | Percentage of participants who complete 70% of surveys will be assessed | End of the Treatment Phase at 12 weeks |
| Proportion of Study Drug Adherence | Percentage of participants who complete 70% of doses will be assessed |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tiffany Walker, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grady Health System | Atlanta | Georgia | 30303 | United States | ||
| Emory University Hospital Midtown |
De-identified datasets may be available to external researchers following final analyses. Requests will be evaluated on a case-by-case basis by PI. No data will be released without proof of Institutional Review Board (IRB) approval or determination. Agreements as required by local policies will be completed when necessary.
Datasets may be available following final analyses and publication.
Proposals should be directed to tiffany.austin.walker@emory.edu.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 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. | Posted | Count of Participants | Participants | End of the Treatment Phase at 12 weeks |
|
Information on adverse events, Serious Adverse Effects were assessed after randomization until completion of the study (12 weeks post-intervention).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sore neck | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tiffany Walker, MD Assistant Professor | Emory University | 404-778-1621 | tiffany.austin.walker@emory.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 20, 2023 | Jun 9, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D000094024 | Post-Acute COVID-19 Syndrome |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D017332 | Cetirizine |
| D015738 | Famotidine |
| ID | Term |
|---|---|
| D006919 | Hydroxyzine |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Famotidine | Drug | 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. |
|
|
| Cetirizine Placebo | Drug | 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 | Drug | 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. |
|
The number of participants that felt they could reach study staff if needed will be recorded as part of the end-of-study survey. |
| End of the Treatment Phase at 12 weeks |
| Number of Participants That Felt That Study Staff Was Available and Easy to Contact to Report Any Adverse Effects | 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. | End of the Treatment Phase at 12 weeks |
| Number of Participants That Felt That the Amount of Information Collected in Each Series of Surveys Was Acceptable | 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. | End of the Treatment Phase at 12 weeks |
| Number of Participants That Felt That the Frequency in Which the Information Was Collected Was Acceptable | 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. | End of the Treatment Phase at 12 weeks |
| Improvement Rating | 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. | End of the Treatment Phase at 12 weeks |
| Quality of Life (QoL) Score Rating | 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. | End of the Treatment Phase at 12 weeks |
| Interest Score | 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. | End of the Treatment Phase at 12 weeks |
| End of the Treatment Phase at 12 weeks |
| Proportion of Lost to Follow Up (LFUP) | Percentage of participants Lost to Follow Up (LFUP) will be assessed | End of the Treatment Phase at 12 weeks |
| Proportion of Voluntary Termination | Percentage of participants that voluntarily terminate participation will be assessed | End of the Treatment Phase at 12 weeks |
| Adverse Events (AEs) Incidence | The mean number of adverse events in the treatment arms will be compared to those in the placebo arm. | End of the Treatment Phase at 12 weeks |
| Serious, Unexpected Suspected Adverse Reactions (SUSAR) Incidence | The number of SUSARs in the treatment arms versus the placebo arm will be recorded. | End of the Treatment Phase at 12 weeks |
| Study-wide Serious Adverse Events (SAEs) Incidence | The total number of SAEs in the treatment arms versus the placebo arm will be recorded. | End of the Treatment Phase at 12 weeks |
| Number of Discontinuations or Temporary Suspensions of IP | The total number of participants who discontinue any of the treatment arms versus the placebo arm will be recorded. | End of the Treatment Phase at 12 weeks |
| Atlanta |
| Georgia |
| 30308 |
| United States |
| Emory Hospital | Atlanta | Georgia | 30322 | United States |
| Metro-Atlanta | Atlanta | Georgia | 30340 | United States |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. |
|
|
| Primary | Number of Participants That Had Trouble Adhering to the Study Drug Schedule | The number of participants that had trouble adhering to the study drug schedule will be recorded as part of the end-of-study survey. | Posted | Count of Participants | Participants | End of the Treatment Phase at 12 weeks |
|
|
|
| Primary | Number of Participants That Had Any Difficulty Using the REDCap Interface. | The number of participants that had any difficulty using the REDCap interface will be recorded as part of the end-of-study survey. | Posted | Count of Participants | Participants | End of the Treatment Phase at 12 weeks |
|
|
|
| Primary | Number of Participants That Prefer Participating in This Virtual Study | 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. | Posted | Count of Participants | Participants | End of the Treatment Phase at 12 weeks |
|
|
|
| Primary | Number of Participants Satisfied With Their Opportunities to Interact With Study Staff | The number of participants satisfied with their opportunities to interact with study staff will be recorded as part of the end-of-study survey. | Posted | Count of Participants | Participants | End of the Treatment Phase at 12 weeks |
|
|
|
| Primary | Number of Participants That Felt They Could Reach Study Staff if Needed | The number of participants that felt they could reach study staff if needed will be recorded as part of the end-of-study survey. | Posted | Count of Participants | Participants | End of the Treatment Phase at 12 weeks |
|
|
|
| Primary | Number of Participants That Felt That Study Staff Was Available and Easy to Contact to Report Any Adverse Effects | 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. | Posted | Count of Participants | Participants | End of the Treatment Phase at 12 weeks |
|
|
|
| Primary | Number of Participants That Felt That the Amount of Information Collected in Each Series of Surveys Was Acceptable | 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. | Posted | Count of Participants | Participants | End of the Treatment Phase at 12 weeks |
|
|
|
| Primary | Number of Participants That Felt That the Frequency in Which the Information Was Collected Was Acceptable | 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. | Posted | Count of Participants | Participants | End of the Treatment Phase at 12 weeks |
|
|
|
| Primary | Improvement Rating | 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. | Posted | Mean | Standard Deviation | Score on a scale | End of the Treatment Phase at 12 weeks |
|
|
|
| Primary | Quality of Life (QoL) Score Rating | 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. | Posted | Mean | Standard Deviation | Score on a scale | End of the Treatment Phase at 12 weeks |
|
|
|
| Primary | Interest Score | 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. | Posted | Mean | Standard Deviation | score on a scale | End of the Treatment Phase at 12 weeks |
|
|
|
| Secondary | Proportion of Survey Completion | Percentage of participants who complete 70% of surveys will be assessed | Posted | Count of Participants | Participants | End of the Treatment Phase at 12 weeks |
|
|
|
| Secondary | Proportion of Study Drug Adherence | Percentage of participants who complete 70% of doses will be assessed | Posted | Count of Participants | Participants | End of the Treatment Phase at 12 weeks |
|
|
|
| Secondary | Proportion of Lost to Follow Up (LFUP) | Percentage of participants Lost to Follow Up (LFUP) will be assessed | Posted | Count of Participants | Participants | End of the Treatment Phase at 12 weeks |
|
|
|
| Secondary | Proportion of Voluntary Termination | Percentage of participants that voluntarily terminate participation will be assessed | Posted | Count of Participants | Participants | End of the Treatment Phase at 12 weeks |
|
|
|
| Secondary | Adverse Events (AEs) Incidence | The mean number of adverse events in the treatment arms will be compared to those in the placebo arm. | Posted | Mean | Standard Deviation | number of adverse events | End of the Treatment Phase at 12 weeks |
|
|
|
| Secondary | Serious, Unexpected Suspected Adverse Reactions (SUSAR) Incidence | The number of SUSARs in the treatment arms versus the placebo arm will be recorded. | Posted | Number | Number of SUSARs | End of the Treatment Phase at 12 weeks |
|
|
|
| Secondary | Study-wide Serious Adverse Events (SAEs) Incidence | The total number of SAEs in the treatment arms versus the placebo arm will be recorded. | Posted | Number | Number of SAEs | End of the Treatment Phase at 12 weeks |
|
|
|
| Secondary | Number of Discontinuations or Temporary Suspensions of IP | The total number of participants who discontinue any of the treatment arms versus the placebo arm will be recorded. | Posted | Count of Participants | Participants | End of the Treatment Phase at 12 weeks |
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 3 |
| 3 |
| EG001 | 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. | 0 | 2 | 0 | 2 | 2 | 2 |
| Upper respiratory infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Herpes Zoster | Infections and infestations | Non-systematic Assessment |
|
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013844 |
| Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |