Antiviral Clinical Trial for Long Covid-19

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT06511063
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • tenofovir disoproxil/emtricitabine — DRUG
    Participants will take Truvada (TDF/FTC, tenofovir disoproxil/emtricitabine) for 90 days.
  • Selzentry — DRUG
    Participants will take Selzentry for 90 days.
  • Placebo — DRUG
    Matching placebo.

Study Details

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.

Key Dates

Start date
Oct 1, 2024
Status verified
Jan 2026
Primary completion
Nov 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: 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.
  • Experimental: Selzentry
    Participants will take 300 mg of Selzentry, twice a day, oral capsule for 90 days.
  • Placebo Comparator: Placebo
    Participants will take a placebo, twice per day, oral capsule for 90 days.

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Cohen Center for Recovery from Complex Chronic Illnesses (CoRE)New YorkNew York10029
Mackenzie Doerstling, MPH
[email protected]
David Putrino (PRINCIPAL_INVESTIGATOR)

Find similar trials in New York, NY

By condition
COVID-19 / long COVID
By specialty
Infectious disease
By research site
The Cohen Center for Recovery from Complex Chronic Illnesses (CoRE)· New York, NY

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