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.
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
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- 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.
United States1 site, 1 recruiting
- Recruiting
The Cohen Center for Recovery from Complex Chronic Illnesses (CoRE)
New York, New York, 10029
Mackenzie Doerstling, MPH, CoreResearch@mountsinai.org
David Putrino
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 group | Role | What they receive |
|---|---|---|
| Truvada (Tenofovir Disoproxil Fumarate, TDF/FTC, tenofovir disoproxil/emtricitabine) | Experimental | Participants 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 |
| Selzentry | Experimental | Participants will take 300 mg of Selzentry, twice a day, oral capsule for 90 days. Receives: Drug: Selzentry |
| Placebo | Placebo comparator | Participants 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.
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)
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted19 Jul 2024
- Study start1 Oct 2024
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long CovidStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Yale University, PolyBio Research Foundation
- Responsible party
- Principal investigator, David Putrino, Icahn School of Medicine at Mount Sinai
- Investigators
- David Putrino, PhD, PT, Principal investigator, Icahn School of Medicine at Mount Sinai
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Feasibility of Repurposing HIV Antivirals in Adults With Long Covid
- ClinicalTrials.gov ID
- NCT06511063
- Acronym / sponsor ID
- STUDY-24-00088
- Conditions
- Long Covid
- Keywords
- Long Covid, Antiviral, Truvada, Selzentry
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Yale University, PolyBio Research Foundation
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 19 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Truvada (Tenofovir Disoproxil Fumarate, TDF/FTC, tenofovir disoproxil/emtricitabine) | Experimental | Drug: tenofovir disoproxil/emtricitabine, Drug: PlaceboParticipants will take 300mg tenofovir disoproxil fumarate/200 mg emtricitabine, once per day, and one placebo capsule per day, oral capsule for 90 days. |
| Selzentry | Experimental | Drug: SelzentryParticipants will take 300 mg of Selzentry, twice a day, oral capsule for 90 days. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will take a placebo, twice per day, oral capsule for 90 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
- At least a six-month history of one of the following symptoms following SARS-CoV-2 infection:
Key exclusion criteria (24 listed)
- Pre-existing conditions including, but not limited to:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tenofovir disoproxil/emtricitabineAlso: TDF/FTC, TruvadaParticipants will take Truvada (TDF/FTC, tenofovir disoproxil/emtricitabine) for 90 days. | Drug | Truvada (Tenofovir Disoproxil Fumarate, TDF/FTC, tenofovir disoproxil/emtricitabine) |
| SelzentryParticipants will take Selzentry for 90 days. | Drug | Selzentry |
| PlaceboMatching placebo. | Drug | Placebo, Truvada (Tenofovir Disoproxil Fumarate, TDF/FTC, tenofovir disoproxil/emtricitabine) |
Primary outcome
EuroQol 5-Dimension 5-Level (EQ-5D-5L) Visual Analogue Scale
Time frame: at Screening, Day 60, Day 90, and Day 180
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).
12 secondary outcomes
The EuroQol Five-Dimensional Health Questionnaire (EQ-5D-5L)
Time frame: at Screening, Day 60, Day 90, and Day 180
Patient-Reported Outcomes Measurement Information System 29 (PROMIS-29)
Time frame: at Screening, Day 60, Day 90, and Day 180
General Symptom Questionnaire (GSQ-30)
Time frame: at Screening, Day 60, Day 90, and Day 180
Patient Health Questionnaire (PHQ-9)
Time frame: at Screening, Day 60, Day 90, and Day 180
Generalized Anxiety Disorder (GAD-7)
Time frame: at Screening, Day 60, Day 90, and Day 180
Neuro-QoL™ v2.0 Cognitive Function-Short Form
Time frame: at Screening, Day 60, Day 90, and Day 180
Single-item Sleep Quality Scale (SQS)
Time frame: at Screening, Day 60, Day 90, and Day 180
Fatigue Severity Scale (FSS)
Time frame: at Screening, Day 60, Day 90, and Day 180
Fatigue Visual Analogue Scale (F-VAS)
Time frame: at Screening, Day 60, Day 90, and Day 180
DePaul Post-Exertional Malaise Questionnaire (DSQ)
Time frame: at Screening, Day 60, Day 90, and Day 180
Composite Autonomic Symptom Score 31(COMPASS-31)
Time frame: at Screening, Day 60, Day 90, and Day 180
Pain Visual Analogue Scale (P-VAS)
Time frame: at Screening, Day 60, Day 90, and Day 180
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Putrino, PhD, PT principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
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.