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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
5
Cetirizine will be dispensed as a 10mg capsule with instructions for patients to take one capsule daily by mouth, preferably at bedtime.
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.
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.
Grady Health System
Atlanta, Georgia, United States
Emory University Hospital Midtown
Atlanta, Georgia, United States
Emory Hospital
Atlanta, Georgia, United States
Metro-Atlanta
Atlanta, Georgia, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: End of the Treatment Phase at 12 weeks
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.
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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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: End of the Treatment Phase at 12 weeks
Proportion of Survey Completion
Percentage of participants who complete 70% of surveys will be assessed
Time frame: End of the Treatment Phase at 12 weeks
Proportion of Study Drug Adherence
Percentage of participants who complete 70% of doses will be assessed
Time frame: 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
Time frame: End of the Treatment Phase at 12 weeks
Proportion of Voluntary Termination
Percentage of participants that voluntarily terminate participation will be assessed
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: End of the Treatment Phase at 12 weeks