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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
United States
New York
The Cohen Center for Recovery from Complex Chronic Illnesses (CoRE)
RECRUITING
New York
Contact Information
Primary
David Putrino, PhD, PT
CoreResearch@mountsinai.org
212-241-8454
Backup
Mackenzie Doerstling, MPH
CoreResearch@mountsinai.org
212-241-8454
Time Frame
Start Date: 2024-10-01
Estimated Completion Date: 2026-01
Participants
Target number of participants: 90
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Yale University, PolyBio Research Foundation
Leads: Icahn School of Medicine at Mount Sinai

This content was sourced from clinicaltrials.gov