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

Recruitment & Eligibility

Status: Terminated

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria: 1. Adults =18 years of age with a history of a SARS-CoV-2 PCR positive test and/or medical records from a healthcare provider that coincides with the diagnosis of long-COVID 2. New or worsened symptoms since the onset of COVID-19 that are persistent at the time of enrollment and have lasted for = 12 weeks (including at least one of the following: fatigue, post-exertional malaise (PEM), headache, brain fog, sleep disturbance, dysautonomia. 3. Confirmation of negative urine or serum human chorionic gonadotropin (HCG) (pregnancy) test in women of childbearing potential 4. Willing to use appropriate contraceptives for female and male subjects for the duration of the study 5. Has an address (for mailing of study drug) in the state of Georgia 6. Able to swallow capsules 7. Has reliable access to a mobile phone, tablet, laptop, or desktop computer capable of connecting to the internet via Wi-Fi or a data plan 8. Available lab work (CBC and CMP) after the onset of long COVID symptoms 9. Willing and able to comply with scheduled visits, treatment plan, and other study procedures including receiving either intervention or placebo 10. Willing to not take any of the study medications while enrolled in the study except for essential needs as prescribed by a healthcare provider Exclusion Criteria: 1. No post-acute COVID-19 symptoms (PASC) symptoms at the time of enrollment or PASC symptoms present <12 weeks at the time of enrollment 2. Inability to provide own informed consent 3. Currently Hospitalized 4. For women of childbearing potential (WOCBP), currently pregnant or plans to become pregnant during the study period; for males with partners of childbearing potential (OCBP), plans to become pregnant during the study period 5. Actively enrolled in another Long COVID/PASC interventional trial or participation in another interventional clinical trial in the last 30 days or planned during the trial period 6. Unstable medical comorbidities (e.g., decompensated cirrhosis, stage III-IV chronic kidney disease, New York Heart Association (NYHA) class III congestive heart failure), per the patient report, telemedicine physical exam, baseline laboratory values (hematology and extended chemistry panels) and/or medical records 7. Other medical conditions occurring after the onset of COVID-19 that can otherwise account for PASC-type symptoms 8. Currently immunocompromised from the following: solid organ transplant, bone marrow transplant (BMT), high dose steroids (>20mg prednisone per day), immune modulators, or chemotherapy 9. Currently taking opioid analgesics, undergoing treatment for opioid addiction, or taking any other prohibited concomitant medication 10. Opioid dependence or withdrawal syndrome 11. Known sensitivity or adverse reaction to H1 or H2 receptor antagonists, or medication components 12. Suspected or confirmed pregnancy or breastfeeding 13. Participants already on H1 or H2 receptor antagonists within three (3) months of randomization 14. Currently receiving other therapies to treat COVID-19 or Long COVID symptoms, e.g., convalescent plasma, remdesivir, Paxlovid

Exclusion Criteria

Not provided

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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;Number of participants that had trouble adhering to the study drug schedule;Number of participants that had any difficulty using the REDCap interface.;Number of participants that prefer participating in this virtual study;Number of participants satisfied with their opportunities to interact with study staff;Number of participants that felt they could reach study staff if needed;Number of participants that felt that study staff was available and easy to contact to report any adverse effects;Number of participants that felt that the amount of information collected in each series of surveys was acceptable;Number of participants that felt that the frequency in which the information was collected was acceptable;Improvement rating;Quality of life (QoL) score rating;Interest score

Secondary Outcome Measures

Name	Time	Method
Proportion of survey completion;Proportion of study drug adherence;Proportion of Lost to Follow Up (LFUP);Proportion of voluntary termination;Adverse events (AEs) incidence;Serious, unexpected suspected adverse reactions (SUSAR) incidence;Study-wide serious adverse events (SAEs) incidence;Number of discontinuations or temporary suspensions of IP

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