Antiviral Clinical Trial for Long Covid-19

NCT ID: NCT06511063

Last Updated: 2026-02-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2026-01-31

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Truvada (Tenofovir Disoproxil Fumarate, TDF/FTC, tenofovir disoproxil/emtricitabine)

Participants will take 300mg tenofovir disoproxil fumarate/200 mg emtricitabine, once per day, and one placebo capsule per day, oral capsule for 90 days.

Group Type: EXPERIMENTAL

tenofovir disoproxil/emtricitabine

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

Matching placebo.

Selzentry

Participants will take 300 mg of Selzentry, twice a day, oral capsule for 90 days.

Group Type: EXPERIMENTAL

Selzentry

Intervention Type: DRUG

Participants will take Selzentry for 90 days.

Placebo

Participants will take a placebo, twice per day, oral capsule for 90 days.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo.

Interventions

tenofovir disoproxil/emtricitabine

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

Intervention Type: DRUG

Selzentry

Participants will take Selzentry for 90 days.

Intervention Type: DRUG

Placebo

Matching placebo.

Intervention Type: DRUG

Other Intervention Names

TDF/FTC; Truvada

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: collaborator

PolyBio Research Foundation

OTHER

Sponsor Role: collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

David Putrino

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Putrino, PhD, PT

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

The Cohen Center for Recovery from Complex Chronic Illnesses (CoRE)

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

David Putrino, PhD, PT

Role: CONTACT

CoreResearch@mountsinai.org

212-241-8454

Mackenzie Doerstling, MPH

Role: CONTACT

CoreResearch@mountsinai.org

212-241-8454

Facility Contacts

Mackenzie Doerstling, MPH

Role: primary

CoreResearch@mountsinai.org

Other Identifiers

STUDY-24-00088

Identifier Type: -

Identifier Source: org_study_id