Treatment of Long CoronaVIrus Disease (COVID) (TLC) Feasibility Trial
COVID-19
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring Long COVID-19
Eligibility Criteria
Inclusion Criteria: 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 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. Confirmation of negative urine or serum human chorionic gonadotropin (HCG) (pregnancy) test in women of childbearing potential Willing to use appropriate contraceptives for female and male subjects for the duration of the study Has an address (for mailing of study drug) in the state of Georgia Able to swallow capsules 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 Available lab work (CBC and CMP) after the onset of long COVID symptoms Willing and able to comply with scheduled visits, treatment plan, and other study procedures including receiving either intervention or placebo 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: No post-acute COVID-19 symptoms (PASC) symptoms at the time of enrollment or PASC symptoms present <12 weeks at the time of enrollment Inability to provide own informed consent Currently Hospitalized 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 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 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 Other medical conditions occurring after the onset of COVID-19 that can otherwise account for PASC-type symptoms Currently immunocompromised from the following: solid organ transplant, bone marrow transplant (BMT), high dose steroids (>20mg prednisone per day), immune modulators, or chemotherapy Currently taking opioid analgesics, undergoing treatment for opioid addiction, or taking any other prohibited concomitant medication Opioid dependence or withdrawal syndrome Known sensitivity or adverse reaction to naltrexone, H1 or H2 receptor antagonists, or medication components Suspected or confirmed pregnancy or breastfeeding Current users of LDN Participants already on H1 or H2 receptor antagonists within three (3) months of randomization Currently receiving other therapies to treat COVID-19 or Long COVID symptoms, e.g., convalescent plasma, remdesivir, Paxlovid
Sites / Locations
- Grady Health System
- Emory University Hospital Midtown
- Emory Hospital
- Metro-Atlanta
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
LDN Treatment Arm
HRA Treatment Arm
Placebo Arm
Participants randomized to Treatment Arm will receive Low-dose Naltrexone.
Participants randomized to Treatment Arm will receive dual histamine receptor antagonists: famotidine and cetirizine daily.
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.