Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 and up

Testing antiviral medications for Long Covid

Official title: Investigating the Feasibility of Repurposing HIV Antivirals in Adults With Long Covid

Run by Icahn School of Medicine at Mount Sinai · NCT06511063 · Data updated 2026-11-12

This study is testing if two HIV antiviral medications can help adults with Long Covid feel better after having symptoms for at least six months.

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment90 (estimated)
SponsorIcahn School of Medicine at Mount Sinai
Academic / other
Drugs / interventionscabozantinib
Locations1 site (New York, New York)
StatusRecruiting
StartedOctober 1, 2024
Main results expectedNovember 2026
Study endsDecember 2026
Registry record updatedMarch 13, 2026
Trial IDNCT06511063 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 and older with a formal diagnosis of Long Covid and a documented history of symptoms for at least six months.

Probably not a fit

Patients who do not have a confirmed diagnosis of Long Covid or have not experienced symptoms for the required duration may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial aims to evaluate the effectiveness of two repurposed HIV antiviral medications, Truvada and Selzentry, in reducing symptoms of Long Covid in adult participants. Participants will be randomly assigned to receive either one of the antivirals or a placebo for a duration of 90 days. The study focuses on individuals who have experienced Long Covid symptoms for at least six months following a confirmed or suspected SARS-CoV-2 infection. The primary goal is to determine if these antivirals can alleviate the symptom burden associated with Long Covid.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients suffering from Long Covid symptoms.

How similar studies have gone: While the approach of repurposing antivirals for Long Covid is novel, there is limited existing research on this specific application.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

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

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.