Actively Recruiting
Investigating HIV Antiviral Drugs Tenofovir Disoproxil/Emtricitabine and Selzentry in Adults with Long Covid to Evaluate Symptom Reduction
Led by Icahn School of Medicine at Mount Sinai · Updated on 2026-03-13
90
Participants Needed
1
Research Sites
113 weeks
Total Duration
On this page
Sponsors
I
Icahn School of Medicine at Mount Sinai
Lead Sponsor
Y
Yale University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This clinical trial is investigating whether two repurposed HIV antiviral drugs can reduce symptoms in adults with Long Covid. The study focuses on adults who have experienced Long Covid symptoms for at least six months following confirmed or suspected COVID-19 infection. The trial aims to compare the effects of these antivirals against a placebo, seeking to better understand potential treatments for symptom relief in Long Covid patients in a Phase 2 setting. Participants are randomly assigned to one of three groups: one group takes Truvada (tenofovir disoproxil/emtricitabine), another takes Selzentry, and the third receives a matching placebo. Each treatment is taken daily for 90 days. The study carefully monitors symptom progression and quality of life during and after treatment to evaluate the impact of these medications. During the study, participants complete evaluations including the EuroQol 5-Dimension 5-Level Visual Analogue Scale at screening, Day 60, Day 90, and Day 180 to measure health-related quality of life. Participants must comply with all study procedures, including laboratory tests and data collection. Safety and symptom burden are closely tracked throughout the study to assess outcomes and potential side effects over a total participation period of about six months.
CONDITIONS
Official Title
Antiviral Clinical Trial for Long Covid-19
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form provided
- Willingness to comply with all study procedures and availability for the study duration
- Any gender, age 18 years or older
- Diagnosed with Long Covid with a confirmed or suspected COVID-19 infection at least 6 months prior
- Formal physician diagnosis of Long Covid with a history of symptoms lasting at least 6 months
- At least six months of symptoms such as headache, memory loss, insomnia, mood disturbance, chest pain, palpitations, shortness of breath, cough, muscle or joint pains, or gastrointestinal upset, along with moderate fatigue and moderate post-exertional malaise
- Willing and able to comply with data collection, treatment plan, laboratory tests, lifestyle considerations, and study procedures
- Baseline EuroQol Visual Analogue Scale (EQ-VAS) score less than or equal to 70, with a pre-infection EQ-VAS score of 80 or higher
You will not qualify if you...
- Pre-existing autoimmune conditions like Chronic EBV, Multiple Sclerosis, or Hashimoto's Disease affecting immune profiling
- Diagnosis before 2020 of other Post-Acute Infectious Syndromes like Chronic Lyme disease or Chronic Fatigue Syndrome
- Documented history of vaccine injury
- Any chronic condition potentially impacting immune profiling as judged by the research physician
- Known HIV positive status
- Current use of Truvada or Selzentry
- Use within 6 weeks of medications known to interact with Truvada or Selzentry
- Current treatment with drugs affecting EBV replication
- Known allergies to components of Truvada or Selzentry
- Febrile illness within 3 months before baseline evaluation
- Treatment with other investigational drugs or interventions within 6 months
- Immunosuppressed individuals or those taking immunosuppressive medications
- Active liver disease or known liver conditions beyond nonalcoholic hepatic steatosis
- Receiving dialysis or known kidney impairment
- Recent hospitalization or surgery within 7 days before study entry
- Other medical or psychiatric conditions making participation unsafe
- Unknown HIV status without completed HIV testing at screening
- Active or latent hepatitis B without completed hepatitis B serologies at screening
- Current severe, progressive, or uncontrolled diseases that pose unacceptable risk
- Creatinine clearance below 75 mL/min
- History of unexplained bone fractures
- Confirmed grade 2 or higher hypophosphatemia
- Grade 2 or higher toxicity on screening tests and assessments
AI-Screening
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Trial Site Locations
Total: 1 location
1
The Cohen Center for Recovery from Complex Chronic Illnesses (CoRE)
New York, New York, United States, 10029
Actively Recruiting
Research Team
D
David Putrino, PhD, PT
M
Mackenzie Doerstling, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
3
Frequently Asked Questions
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