Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-24 @ 11:44 PM
NCT ID:
NCT05946551
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05946551
Study Brief:
Protocol Section:
NCT05946551