Antiviral Clinical Trial for Long Covid-19

NCT06511063 | Recruiting Phase 2 FDA Drug

• 1 other identifier: STUDY-24-00088
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Keywords

Long Covid; Antiviral; Truvada; Selzentry

Outcome Measures

Primary Outcomes (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).

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

Secondary Outcomes (12)

• The EuroQol Five-Dimensional Health Questionnaire (EQ-5D-5L)

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

• Patient-Reported Outcomes Measurement Information System 29 (PROMIS-29)

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

• General Symptom Questionnaire (GSQ-30)

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

• Patient Health Questionnaire (PHQ-9)

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

• Generalized Anxiety Disorder (GAD-7)

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

Study Arms (3)

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.

Drug: tenofovir disoproxil/emtricitabine; Drug: Placebo

Selzentry

EXPERIMENTAL

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

Drug: Selzentry

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

tenofovir disoproxil/emtricitabine DRUG

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

Also known as: TDF/FTC, Truvada

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

Selzentry DRUG

Participants will take Selzentry for 90 days.

Selzentry

Placebo DRUG

Matching placebo.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Yale University: collaborator
• PolyBio Research Foundation: collaborator

Study Sites (1)

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

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Interventions

Tenofovir; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Maraviroc

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Drug Combinations; Pharmaceutical Preparations; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Triazoles; Azoles

Study Officials

• David Putrino, PhD, PT

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Putrino, PhD, PT

CONTACT

212-241-8454; CoreResearch@mountsinai.org

Mackenzie Doerstling, MPH

CONTACT

212-241-8454; CoreResearch@mountsinai.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: July 19, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)