Antiviral Drugs for Long COVID
Recruiting in Palo Alto (17 mi)
Overseen byDavid Putrino, PhD, PT
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Icahn School of Medicine at Mount Sinai
Must not be taking: Antivirals, NSAIDs, Immunosuppressants, others
Disqualifiers: Autoimmune conditions, HIV+, Hepatitis, others
Prior Safety Data
Approved in 5 Jurisdictions
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial requires that you stop taking any medications that interact with Truvada or Selzentry at least 6 weeks before starting the study. If you are currently using Truvada, Selzentry, or medications affecting EBV replication, you cannot participate.
What data supports the effectiveness of the drug Tenofovir disoproxil/emtricitabine (Truvada) for Long COVID?
The drug Tenofovir disoproxil/emtricitabine (Truvada) has shown effectiveness in treating HIV and hepatitis B, as it is a potent antiviral combination. While there is no direct evidence for its use in Long COVID, its antiviral properties in other conditions suggest potential benefits.
12345How is the drug Tenofovir disoproxil/emtricitabine unique for treating Long COVID?
Tenofovir disoproxil/emtricitabine is unique for Long COVID as it targets the RNA polymerase of the virus, potentially reducing viral load, and is already known for its effectiveness against HIV and hepatitis B. This drug is taken as a single daily pill, which is convenient compared to other treatments that may require more frequent dosing or different administration routes.
45678Eligibility Criteria
Adults suffering from Long Covid, who experience ongoing symptoms after recovering from the initial COVID-19 infection. Participants must be willing to take medication daily for 90 days. Specific inclusion and exclusion criteria details are not provided.Inclusion Criteria
I am willing and able to follow all study rules and attend all appointments.
Provision of signed and dated informed consent form
I am 18 years old or older.
+6 more
Exclusion Criteria
I have been diagnosed with moderate to severe low phosphate levels.
I have had bone fractures without any injury.
I am not taking medications that affect EBV replication.
+20 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
1 visit (in-person)
Treatment
Participants receive either Truvada, Selzentry, or a placebo daily for 90 days
12 weeks
3 visits (in-person) at Day 0, Day 45, and Day 90
Follow-up
Participants are monitored for safety and effectiveness after treatment
12 weeks
1 visit (in-person) at Day 180
Participant Groups
The trial is examining if two HIV antivirals, Truvada (tenofovir disoproxil/emtricitabine) or Selzentry, can alleviate Long Covid symptoms compared to a placebo. Patients will be randomly assigned to one of three groups and treated for 90 days.
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Truvada (Tenofovir Disoproxil Fumarate, TDF/FTC, tenofovir disoproxil/emtricitabine)Experimental Treatment1 Intervention
Participants will take 300mg tenofovir disoproxil fumarate/200 mg emtricitabine, once per day, oral capsule for 90 days.
Group II: SelzentryExperimental Treatment1 Intervention
Participants will take 300 mg of Selzentry, twice a day, oral capsule for 90 days.
Group III: PlaceboPlacebo Group1 Intervention
Participants will take a placebo, once per day, oral capsule for 90 days.
Tenofovir disoproxil/emtricitabine is already approved in European Union, United States, Canada, Japan, Australia for the following indications:
🇪🇺 Approved in European Union as Truvada for:
- HIV-1 infection
- Pre-exposure prophylaxis (PrEP)
🇺🇸 Approved in United States as Truvada for:
- HIV-1 infection
- Pre-exposure prophylaxis (PrEP)
- Post-exposure prophylaxis (PEP)
🇨🇦 Approved in Canada as Truvada for:
- HIV-1 infection
- Pre-exposure prophylaxis (PrEP)
🇯🇵 Approved in Japan as Truvada for:
- HIV-1 infection
🇦🇺 Approved in Australia as Truvada for:
- HIV-1 infection
- Pre-exposure prophylaxis (PrEP)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
The Cohen Center for Recovery from Complex Chronic Illnesses (CoRE)New York, NY
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Who Is Running the Clinical Trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
PolyBio Research FoundationCollaborator
Yale UniversityCollaborator
References
Tenofovir disoproxil fumarate is superior to lamivudine plus adefovir in lamivudine-resistant chronic hepatitis B patients. [2022]To assess the efficacy of tenofovir disoproxil fumarate (TDF) in lamivudine (LAM)-resistant patients with a suboptimal response to LAM plus adefovir (ADV).
Brief Report: Long-Term (96-Week) Efficacy and Safety After Switching From Tenofovir Disoproxil Fumarate to Tenofovir Alafenamide in HIV-Infected, Virologically Suppressed Adults. [2022]In a double-blind, phase 3 trial, 663 HIV-infected, virologically suppressed adults were randomized to switch to tenofovir alafenamide (TAF; n = 333) vs. remain on tenofovir disoproxil fumarate (TDF; n = 330), each coformulated with emtricitabine (FTC), while continuing their third agent (boosted protease inhibitor or unboosted third agent). At week 96, 88.6% on FTC/TAF and 89.1% on FTC/TDF had HIV-1 RNA
Long-term efficacy and safety of tenofovir disoproxil fumarate in HIV-1-infected adolescents failing antiretroviral therapy: the final results of study GS-US-104-0321. [2015]Reports of long-term tenofovir disoproxil fumarate (TDF) treatment in HIV-infected adolescents are limited. We present final results from the open-label (OL) TDF extension following the randomized, placebo (PBO)-controlled, double-blind phase of GS-US-104-0321 (Study 321).
Tenofovir disoproxil fumarate-emtricitabine coformulation for once-daily dual NRTI backbone. [2015]Truvada is the coformulation of tenofovir disoproxil fumarate (TDF; 300 mg) and emtricitabine (FTC; 200 mg) in a single tablet, providing the nucleotide backbone for once-daily dosing, as a component of highly active antiretroviral therapy (HAART). TDF (the bioavailable prodrug of tenofovir) is hydrolyzed to tenofovir intracellularly and phosphorylated to the active metabolite, tenofovir diphosphate. Tenofovir is a nucleotide analog of deoxyadenosine monophosphate, with activity against HIV-1, -2 and hepatitis B virus. FTC, the fluorinated derivative of lamivudine, is an analog of deoxycitidine, active against HIV-1, -2 and hepatitis B virus. Their long half-lives in plasma and in peripheral blood mononuclear cells allow once-daily dosing. Both are eliminated renally. Resistance mutation K65R is selected for by tenofovir and confers a two- to fourfold reduced susceptibility to this drug. The incidence of K65R is low (3%) and has not been observed in clinical trials with the concomitant use of tenofovir and FTC. FTC selects for M184V mutation less frequently than lamivudine. Tenofovir drug interactions include increased exposure to didanosine and inferior immune recovery that preclude their concomitant use. Boosted protease inhibitors increase exposure to tenofovir without dose adjustment required. FTC has no significant drug interactions. They are not metabolized by cytochrome P450, which confers little potential for interactions with drugs metabolized by these enzymes. As tenofovir and FTC are renally eliminated, drugs eliminated by tubular secretion must be avoided. Both antiretrovirals, as individual agents and in coadministration have evidenced antiviral potency in clinical trials. Pivotal study 934 evidenced superior efficacy of the combination TDF/FTC/efavirenz (EFV) versus zidovudine/FTC/EFV. The toxicity profile of tenofovir and FTC has been extensively studied. Lipid profile is more favorable with tenofovir than thymidine analog. Tenofovir requires surveillance of glomerular filtration rate and dosing interval adjustment when creatinine clearance is less than 50 ml/min and avoidance less than 30 ml/min. Fat loss is less likely with tenofovir than with thymidine analog. Clinical trials have assessed the performance of the coformulation of TDF and FTC.
Use of tenofovir disoproxil fumarate and emtricitabine combination in HIV-infected patients. [2019]With the continuing spread of HIV infection, particularly in developing countries, cost-effective treatment for its management is a high priority. Truvada (Gilead Sciences) is a single combination pill of the nucleotide reverse transcriptase inhibitors tenofovir disoproxil fumarate and emtricitabine, which is used once daily. It is anticipated to be a clinically potent combination that is free of short-term irritating toxicity. The drug has recently been licensed but there are currently little clinical efficacy data regarding its use. The limited published data have indicated that emtricitabine and lamivudine have equivalent potency, and randomised controlled trials have produced evidence of the efficacy of lamivudine combined with tenofovir disoproxil fumarate in a regimen containing either the non-nucleoside reverse transcriptase inhibitor efavirenz or a protease inhibitor lopinavir/ritonavir. In these trials, long-term durability data are available for
Change in Renal Function among HIV-Infected Koreans Receiving Tenofovir Disoproxil Fumarate-Backbone Antiretroviral Therapy: A 3-Year Follow-Up Study. [2022]Tenofovir disoproxil fumarate (TDF) is commonly prescribed as a fixed-dose, co-formulated antiretroviral drug for HIV-1 infection. The major concern of long-term TDF use is renal dysfunction. However, little is known about the long-term patterns of changes in renal function in HIV-infected Koreans receiving TDF.
Effect of Tenofovir Disoproxil Fumarate and Emtricitabine on nasopharyngeal SARS-CoV-2 viral load burden amongst outpatients with COVID-19: A pilot, randomized, open-label phase 2 trial. [2022]Tenofovir and emtricitabine interfere with the SARS CoV-2 ribonucleic acid (RNA)-dependent RNA polymerase (RdRp). Several cohorts reported that people treated by tenofovir disoproxil fumarate and emtricitabine are less likely to develop SARS CoV-2 infection and related severe COVID-19.
Tenofovir: quo vadis anno 2012 (where is it going in the year 2012)? [2015]Twenty years after its original discovery, tenofovir has acquired a crucial position in the fight against human immunodeficiency virus (HIV). First, tenofovir disoproxil fumarate (TDF) is not only efficacious against, and has been licensed for the treatment of HIV (AIDS), but also HBV (hepatitis B). Second, for the treatment of HIV infections, TDF can be used in combination with other anti-HIV drugs, such as emtricitabine (combination termed Truvada(®)) and Truvada can be further combined with efavirenz, rilpivirine, elvitegravir, atazanavir, or darunavir, as a single once-daily oral pill. Third, Truvada can be used prophylactically to prevent transmission of HIV infection. And fourth, to prevent sexual HIV transmission, tenofovir could also be used topically (i.e., as a vaginal gel).