RECRUITING

Antiviral Clinical Trial for Long Covid-19

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Investigating the Feasibility of Repurposing HIV Antivirals in Adults with Long Covid

Quick Facts

Study Start:2024-10-01

Study Completion:2026-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06511063

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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).	* 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

Inclusion Criteria

Exclusion 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).

* 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

Contacts and Locations

Study Contact

David Putrino, PhD, PT

CONTACT

212-241-8454

CoreResearch@mountsinai.org

Mackenzie Doerstling, MPH

CONTACT

212-241-8454

CoreResearch@mountsinai.org

Principal Investigator

David Putrino, PhD, PT

PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Study Locations (Sites)

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

New York, New York, 10029

United States

Collaborators and Investigators

Sponsor: Icahn School of Medicine at Mount Sinai

David Putrino, PhD, PT, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-01

Study Completion Date2026-01

Study Record Updates

Study Start Date2024-10-01

Study Completion Date2026-01

Terms related to this study

Keywords Provided by Researchers

Long Covid
Antiviral
Truvada
Selzentry

Additional Relevant MeSH Terms

Long Covid