NCT05449405

Chlorpheniramine Nasal Spray to Accelerate COVID-19 Clinical Recovery in an Outpatient Setting: ACCROS-I

A Multicentric, Randomized, Double-Blind, Comparative, Prospective, Placebo-controlled, Phase-II/III Clinical Trial (ACCROS-I)

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Dr. Ferrer BioPharma · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to examine the effectiveness of intranasal-administered Chlorpheniramine Maleate in COVID-19-positive participants as part of early treatment for COVID-19. The main questions it aims to answer are: * To assess the efficacy of nasal spray with Chlorpheniramine (1.0%) for improving clinical recovery in COVID-19 patients. * To assess the efficacy, safety, and tolerability of nasal spray with Chlorpheniramine (1%) as an adjunct to the standard of care in reducing hospitalizations and improving clinical recovery in adult patients with mild COVID-19.

Detailed description

The main goal of the present study is to examine the effectiveness of CPM intranasal spray as part of early treatment for COVID-19. The study will test the hypothesis that intranasal CPM would accelerate clinical recovery, particularly the alleviation of sensory symptoms and URS, in patients with COVID-19.

Conditions

• COVID-19
• Symptoms and Signs
• COVID-19 Pandemic
• Coronavirus Disease 2019
• Coronavirus Infections

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Chlorpheniramine Maleate 1% Nasal Spray	Chlorpheniramine Maleate 1% Nasal Spray
COMBINATION_PRODUCT	Placebo	Placebo nasal spray

Timeline

• Start date: 2021-12-07
• Primary completion: 2022-03-11
• Completion: 2022-03-11
• First posted: 2022-07-08
• Last updated: 2023-03-23

Locations

1 site across 1 country: Honduras

Regulatory

• FDA-regulated drug study
• FDA-regulated device study