Official Title
Investigating the Feasibility of Repurposing HIV Antivirals in Adults With Long Covid
Brief Summary

The trial will test if two repurposed HIV antivirals can reduce symptom burden in adultparticipants with Long Covid compared to placebo. Viral infection and viral reactivationhave been documented in Long Covid.Participants will be randomly allocated to receive antivirals, Truvada (tenofovirdisoproxil/emtricitabine, TDF/FTC, Group 1) or Selzentry (Group 2), or a placebo (pill)(Group 3), taken daily for 90 days.

Detailed Description

Not Provided

Recruiting
Long Covid

Drug: tenofovir disoproxil/emtricitabine

Participants will take Truvada (TDF/FTC, tenofovir disoproxil/emtricitabine) for 90 days.
Other Name: TDF/FTC,Truvada

Drug: Selzentry

Participants will take Selzentry for 90 days.

Drug: Placebo

Matching placebo.

Eligibility Criteria

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 Chronic
Lyme disease, Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, etc.

- Documented history of vaccine injury

- Or any other chronic condition that has the potential to impact on
immunological profiling, at the discretion of the research physician

- HIV+ status

- Current use of either Truvada or Selzentry

- Taking a medication, within 6 weeks, with known interactions with Truvada or
Selzentry including but not limited to: Acyclovir, valacyclovir, adefovir,
cabozantinib, carbamazepine, cidofovir, cladribine, cobicistat, diclofenac, multiple
NSAIDs or chronic high dose NSAIDs, fosphenytoin or phenytoin, ganciclovir,
valganciclovir, oxcarbazepine, phenobarbital, primidone, rifabutin, rifampin,
rifapentine, sofosbuvir, tipranavir, or other drugs that significantly affect renal
function

- Current treatment with drugs known to affect EBV replication, including but not
limited to: Acyclovir, valacyclovir, ganciclovir, valganciclovir, famciclovir,
teriflunomide, interferon

- Known allergic reactions to components of Truvada or Selzentry

- Febrile illness within the last 3 months of planned baseline evaluation

- Treatment with another investigational drug or other investigational intervention
within 6 months of planned baseline evaluation

- Immunosuppressed individuals (transplant on antiviral prophylaxis and/or patients
taking immunosuppressive medications such as steroids, etc.)

- Known medical history of active liver disease (other than nonalcoholic hepatic
steatosis), including chronic or active hepatitis B or C infection, primary biliary
cirrhosis, Child-Pugh Class B or C, or acute liver failure

- Receiving dialysis or have known renal impairment

- Any comorbidity requiring hospitalization and/or surgery within 7 days prior to
study entry, or that is considered life threatening within days prior to study
entry, as determined by the study team

- Other medical or psychiatric conditions, in the treating investigator's judgment,
that makes the participant inappropriate for the study

- Unknown HIV status (subjects must have completed HIV antigen/antibody and viral load
testing completed at the screening visit)

- Active or latent hepatitis B (subjects must have completed HBV serologies - HbsAg,
anti-HBs, and anti-HBc - testing completed at the screening visit)

- Current symptoms of severe, progressive, or uncontrolled renal, hematologic,
gastrointestinal, pulmonary, cardiac, or neurologic disease, or other medical
conditions that, in the opinion of the investigator, might place the subject at
unacceptable risk for participation in this study

- Creatinine clearance (CrCl) <75mL/min, as calculated by the Cockcroft-Gault equation

- Any history of bone fractures not explained by trauma

- Confirmed Grade 2 or greater hypophosphatemia

- Any Grade 2 or greater toxicity on screening tests and assessments

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

The Cohen Center for Recovery from Complex Chronic Illnesses (CoRE)
New York 5128581, New York 5128638, United States

Investigator: Mackenzie Doerstling, MPH
CoreResearch@mountsinai.org

Investigator: David Putrino

Contacts

David Putrino, PhD, PT
212-241-8454
CoreResearch@mountsinai.org

Mackenzie Doerstling, MPH
212-241-8454
CoreResearch@mountsinai.org

David Putrino, PhD, PT, Principal Investigator
Icahn School of Medicine at Mount Sinai

Icahn School of Medicine at Mount Sinai
NCT Number
Keywords
long COVID
Antiviral
truvada
Selzentry
MeSH Terms
Post-Acute COVID-19 Syndrome
Tenofovir
Emtricitabine
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Maraviroc