NCT05592418

Study to Evaluate the Efficacy and Safety of Ampligen in Patients With Post-COVID Conditions

A Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Ampligen® in Patients With Post-COVID Conditions

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: AIM ImmunoTech Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the efficacy and safety of Ampligen® administered twice weekly by intravenous (IV) infusions in subjects experiencing the Post-COVID Condition of fatigue.

Detailed description

This is a Phase 2, two-arm, randomized, double blind, placebo controlled multicenter study to evaluate the efficacy and safety of Ampligen® in patients experiencing the Post-COVID Condition of fatigue. Patients will be randomized 1:1 to receive twice weekly IV infusions of Ampligen® or placebo.

Conditions

• Post COVID-19 Condition
• Long COVID

Interventions

Type	Name	Description
DRUG	Rintatolimod	100 to 400 mg twice weekly
OTHER	Placebo / Normal Saline	40 to 160 mL twice weekly

Timeline

• Start date: 2023-06-30
• Primary completion: 2023-11-17
• Completion: 2023-11-30
• First posted: 2022-10-24
• Last updated: 2025-01-22
• Results posted: 2025-01-22

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study