Antiviral Clinical Trial for Long Covid-19 (NCT06511063) | Clinical Trial Compass
RecruitingPhase 2
Antiviral Clinical Trial for Long Covid-19
United States90 participantsStarted 2024-10-01
Plain-language summary
The trial will test if two repurposed HIV antivirals can reduce symptom burden in adult participants with Long Covid compared to placebo. Viral infection and viral reactivation have been documented in Long Covid.
Participants will be randomly allocated to receive antivirals, Truvada (tenofovir disoproxil/emtricitabine, TDF/FTC, Group 1) or Selzentry (Group 2), or a placebo (pill) (Group 3), taken daily for 90 days.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Any gender, aged 18+
* Diagnosed with:
* Long Covid
* Documented clinical history of confirmed or suspected acute SARS-CoV-2 infection a minimum of 6 months prior to contact with the study team
* Formal diagnosis of Long Covid from a physician and a history of 6 months of Long COVID symptoms
* At least a six-month history of one of the following symptoms following SARS-CoV-2 infection:
* headache, memory loss, insomnia, mood disturbance, chest pain, palpitations, shortness of breath, cough, muscle pains, joint pains, or GI upset\] AND at least moderate fatigue (measured by Fatigue Severity Score) AND at least moderate post-exertional malaise (PEM) (measured by DePaul PEM screener)
* Participants who are willing and able to comply with all data collection, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
* Baseline EQ-VAS ≤70; EQ-VAS before the index infection ≥80 (this information is collected before randomization as part of the baseline survey).
Exclusion Criteria:
* Pre-existing conditions including, but not limited to:
* Autoimmune conditions such as Chronic EBV, Multiple Sclerosis, Hashimoto's Disease, etc. which would impact the immunological profiling analysis.
* A pre-2020 diagnosis of another Post-Acute Infectious Syndrome such as Chro…