Protocol Investigating the Feasibility of Repurposing HIV Antivirals in Adults With Long Covid [tenofovir/emtricitabine or maraviroc]

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, TDF (Group 1) or Maraviroc (Group 2), or a placebo (pill) (Group 3), taken daily for 90 days.

Arms and Interventions

Participant Group/Arm
Experimental: Tenofovir Disoproxil Fumarate (TDF, tenofovir/emtricitabine)
Participants will take 300mg tenofovir disoproxil fumarate/200 mg emtricitabine, once per day, oral capsule (tenofovir/emtricitabine) for 90 days.

• Other Names:
  • Truvada

Participant Group/Arm
Experimental: Maraviroc
Participants will take 300 mg of Maraviroc, twice a day, oral capsule for 90 days.

Participant Group/Arm
Placebo Comparator: Placebo
Participants will take a placebo, once per day, oral capsule for 90 days.​

Estimated Enrollment: 90

Estimated study completion: 2026-01

Location
The Cohen Center for Recovery from Complex Chronic Illnesses (CoRE)
New York, New York, United States

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

Outcome
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).

Time frame: Screening, Day 45, Day 90, and Day 180

Collaborators
PolyBio Research Foundation
Yale University

ClinicalTrials.gov

 

How do they blind the trial if the dosage is different for Maraviroc?

 

Can't they just make a bigger capsule with inert filler for the smaller dosage? (Just guessing, no idea if that is common practice.)

 

Inclusion criteria requires PEM (assessed with DePaul PEM questionnaire)

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Inclusion Criteria:

Exclusion Criteria:

 

It doesn't matter how they make the placebos if everyone who is told to take two capsules a day will know they are taking maraviroc...

 

Oh right, twice a day. That is a challenge. Maybe they can make everyone take two capsules a day, for Truvada one would be placebo.

Though a curious participant probably wouldn't have a hard time figuring out the capsules are different.

 

I got an answer from them. They said that everyone will be getting 2 doses per day and they are in the process of updating the registration.