AzTrials
AzTrials

Long CovidPhase 2NCT06511063

Antiviral Clinical Trial for Long Covid-19

A Phase 2 study testing tenofovir disoproxil/emtricitabine and Selzentry in people with Long Covid, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Long Covid
What is being tested?
tenofovir disoproxil/emtricitabine and Selzentry
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
1 siteUnited States
Study dates
1 Oct 2024to Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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).

Who cannot join

  • 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
Show all 24Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

David Putrino, PhD, PT contact

212-241-8454

CoreResearch@mountsinai.org

Mackenzie Doerstling, MPH contact

212-241-8454

CoreResearch@mountsinai.org

United States1 site, 1 recruiting
  • The Cohen Center for Recovery from Complex Chronic Illnesses (CoRE)

    New York, New York, 10029

    Mackenzie Doerstling, MPH, CoreResearch@mountsinai.org

    David Putrino

    Recruiting

Other trials in United States

About this study

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

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.

Conditions
Long Covid
Being tested
tenofovir disoproxil/emtricitabine, Selzentry, Placebo
Keywords
Long Covid, Antiviral, Truvada, Selzentry
Medical subject headings
Post-Acute COVID-19 Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tenofovir disoproxil/emtricitabineDrug

    Also called TDF/FTC, Truvada

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

  • SelzentryDrug

    Participants will take Selzentry for 90 days.

  • PlaceboDrug

    Matching placebo.

Study groups in NCT06511063
Study groupRoleWhat they receive
Truvada (Tenofovir Disoproxil Fumarate, TDF/FTC, tenofovir disoproxil/emtricitabine)ExperimentalParticipants will take 300mg tenofovir disoproxil fumarate/200 mg emtricitabine, once per day, and one placebo capsule per day, oral capsule for 90 days.
Receives: Drug: tenofovir disoproxil/emtricitabine; Drug: Placebo
SelzentryExperimentalParticipants will take 300 mg of Selzentry, twice a day, oral capsule for 90 days.
Receives: Drug: Selzentry
PlaceboPlacebo comparatorParticipants will take a placebo, twice per day, oral capsule for 90 days.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. EuroQol 5-Dimension 5-Level (EQ-5D-5L) Visual Analogue Scale

    The EQ-5D-5L is a standardized measure of health status that consists of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each with 5 levels of severity, and a visual analogue scale (VAS) where individuals rate their overall health from 0 (worst imaginable health) to 100 (best imaginable health).

    Measured: at Screening, Day 60, Day 90, and Day 180

Secondary outcomes (12)
  1. The EuroQol Five-Dimensional Health Questionnaire (EQ-5D-5L)

    The EQ-5D-5L is a validated, standardized, generic instrument that is a preference-based health- related quality of life questionnaire. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate their health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. Full scale from 5 to 25, with higher score indicating poorer health outcomes.

    Measured: at Screening, Day 60, Day 90, and Day 180

  2. Patient-Reported Outcomes Measurement Information System 29 (PROMIS-29)

    The PROMIS-29 v2.0 profile assesses pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items per domain. The values of all item responses are averaged to generate subscores for each dimension. From these subscores, a global physical health score and a global mental health score are generated. The scores are translated into T-scores according to a reference population with a mean of 50 and a standard deviation of 10.

    Measured: at Screening, Day 60, Day 90, and Day 180

  3. General Symptom Questionnaire (GSQ-30)

    The General Symptom Questionnaire-30 (GSQ-30) is a valid and reliable instrument to assess symptom burden among patients with acute and post-treatment. The GSQ-30 total score ranges from 0 to 120, with higher scores indicating a greater symptom burden.

    Measured: at Screening, Day 60, Day 90, and Day 180

  4. Patient Health Questionnaire (PHQ-9)

    The PHQ-9 is a series of questions assessing presence and severity of depression symptoms. It evaluates each of the DSM-IV depression criteria and scores the responses from 0 ("Not at all") to 3 ("Nearly every day"). PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively. Full scale from 0-27, with higher score indicating more severe symptoms.

    Measured: at Screening, Day 60, Day 90, and Day 180

  5. Generalized Anxiety Disorder (GAD-7)

    The GAD-7 is a 7-item scale developed and validated to identify generalized anxiety disorder and its severity. It assesses the frequency of 7 anxiety symptoms and scores the responses from 0 ("Not at all") to 3 ("Nearly every day"). Total scores of 5, 10, and 15 correspond to mild, moderate, and severe generalized anxiety disorder, respectively. Full scale from 0-21, with higher score indicating more symptoms.

    Measured: at Screening, Day 60, Day 90, and Day 180

  6. Neuro-QoL™ v2.0 Cognitive Function-Short Form

    The Neuro-QoL Cognitive Function v2.0 short form assesses perceived difficulties in cognitive abilities, including memory, attention, decision making, planning, organizing, calculating, remembering, and learning. The short form consists of 8 questions assessed on a 5-point Likert scale, resulting in a raw score range of 8 to 40. A raw score is then converted to a T-score using conversion tables. Scores 0.5 - 1.0 SD worse than the mean (T-score 40-45) = mild symptoms/impairment. Scores 1.0 - 2.0 SD worse than the mean (T-score 30-40) = moderate symptoms/impairment. Scores 2.0 SD or more worse than the mean (T-score below 30) = severe symptoms/impairment.

    Measured: at Screening, Day 60, Day 90, and Day 180

  7. Single-item Sleep Quality Scale (SQS)

    The SQS is a visual analog scale that instructs respondents to rate their overall quality of sleep over a 7-day recall period from 0 to 10. Scores of 0, 1, 4, 7, and 10 correspond to terrible, poor, fair, good, and excellent, respectively. Higher scores indicate better sleep quality.

    Measured: at Screening, Day 60, Day 90, and Day 180

  8. Fatigue Severity Scale (FSS)

    The Fatigue Severity Scale (FSS) uses a 7-point scale (1-7) to assess fatigue, with higher scores indicating greater severity, and a total score ranging from 9 to 63. Higher scores indicate more severe fatigue.

    Measured: at Screening, Day 60, Day 90, and Day 180

  9. Fatigue Visual Analogue Scale (F-VAS)

    The F-VAS consists of 18 items related to fatigue and energy in a visual analogue scale from 0 to 100. A higher score indicates more fatigue.

    Measured: at Screening, Day 60, Day 90, and Day 180

  10. DePaul Post-Exertional Malaise Questionnaire (DSQ)

    The DSQ is designed to evaluate 54 classic ME/CFS symptoms, including fatigue, post-exertional malaise, sleep, pain, neurological/cognitive impairments, and autonomic, neuroendocrine, and immune symptoms. Each symptom's frequency and intensity are rated on a 5-point scale (0-4). Frequency and severity scores are multiplied by 25, added together, and then divided by 2 to create a composite frequency/severity score for each symptom. These scores range from 0 to 100, with higher scores indicating a greater symptom burden.

    Measured: at Screening, Day 60, Day 90, and Day 180

  11. Composite Autonomic Symptom Score 31(COMPASS-31)

    The COMPASS-31 is a 31-question self-assessment instrument of autonomic symptoms and function that is up-to-date, broadly applicable, easy to administer in a short amount of time, and based on a scientific approach. The total score ranges from 0 to 100, with higher scores indicating greater autonomic dysfunction.

    Measured: at Screening, Day 60, Day 90, and Day 180

  12. Pain Visual Analogue Scale (P-VAS)

    Using a visual analogue scale, patients mark a point on a line representing a continuum from "no pain" to "worst pain," with scores ranging from 0 to 100, where higher scores indicate greater pain.

    Measured: at Screening, Day 60, Day 90, and Day 180

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2024
  2. Study start1 Oct 2024
  3. Primary completionNov 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06511063
Sponsor's protocol ID
STUDY-24-00088
Status last verified
Jan 2026
First submitted
16 Jul 2024
Last updated
13 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing tenofovir disoproxil/emtricitabine and Selzentry in people with Long Covid, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact David Putrino, PhD, PT (212-241-8454, CoreResearch@mountsinai.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

EuroQol 5-Dimension 5-Level (EQ-5D-5L) Visual Analogue Scale (time frame: at Screening, Day 60, Day 90, and Day 180). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in