NCT04944121

Phase 2 Study of RSLV-132 in Subjects With Long COVID

A Phase 2, Double-blind, Placebo-controlled Study of RSLV-132 in Subjects With Post-acute COVID-19 (Long COVID)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Resolve Therapeutics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the efficacy (decrease in profound fatigue), safety and pharmacokinetics of RSLV-132 in subjects with long Corona Virus (COVID) syndome

Detailed description

This is a double-blind placebo-controlled study in approximately 70 subjects with long COVID syndrome. After being informed about the study and potential risks, all subjects giving written informed consent will be screened to determine eligibility in the 21 days before the start of study treatment. Prior to the first study treatment administration, subjects will be randomized in a 2:1 ratio to receive six administrations of 10 mg/kg RSLV-132 or placebo on Days 1, 8, 15, 29, 43 and 57. Subjects will then attend an end of study visit approximately 10 weeks after the start of treatment (Day 71).

Conditions

• Post-acute Corona Virus 19 (COVID-19) (Long COVID)

Interventions

Type	Name	Description
DRUG	RSLV-132	10 mg/kg RSLV-132 administered by intravenous infusion
DRUG	Sodium Chloride 0.9%	0.9% sodium chloride administered by intravenous infusion

Timeline

• Start date: 2021-06-25
• Primary completion: 2023-10-31
• Completion: 2023-11-30
• First posted: 2021-06-29
• Last updated: 2024-05-29

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study