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Chlorpheniramine Nasal Spray to Accelerate COVID-19 Clinical Recovery in an Outpatient Setting: ACCROS-III | Clinical Trials | Clareo Health

COMPLETEDPHASE2/PHASE3

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

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

NCT05886829•Dr. Ferrer BioPharma

View on ClinicalTrials.gov

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 (0.4%) for improving clinical recovery in COVID-19 patients. * To assess the efficacy, safety, and tolerability of nasal spray with Chlorpheniramine (0.4%) 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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Male or female patients between 18 and 65 years (both inclusive)
•Patients with positive RT-PCR test for SARS-CoV-2 in nasopharyngeal or oropharyngeal swabs (sample collected or proof of positive test ≤3 days before randomization)
•Patients with mild COVID-19 have the following symptoms and signs prior to randomization (≤ 3days)
•Upper respiratory tract symptoms (\&/or fever) without shortness of breath or hypoxia. (SpO2 \> 94 %)
•Willingness to sign written informed consent document

Exclusion Criteria

•\< 18 years of age
•Hospitalized patients
•Subject with known allergy or hypersensitivity to the components of the formulation.
•Patients receiving therapy with Monoamine oxidase inhibitors (MAOIs): rasagline, selegiline, isocarbonboxasid, phenelzine, tranylcypromine.
•Patients with narrow-angle glaucoma
•urinary retention
•Sleep Apnea
•History of immunodeficiency or receiving immunosuppressive therapy.
•Patients with acute exacerbation of severe comorbidities such as chronic obstructive pulmonary disease (COPD), class 3 and 4 heart failure diagnosed according to the criteria of the New York Heart Failure Association (NYHA), or diseases with severe oxygenation problems
•Any Surgical procedure in the past 12 weeks
+6 more criteria

Locations (1)

Hospital CEMESA

Cortés, San Pedro Sula, Honduras

Key Dates

Start Date

July 27, 2022

Primary Completion Date

January 19, 2023

Completion Date

February 1, 2023

Last Updated

June 2, 2023

Enrollment

157

ACTUAL participants

Conditions

COVID-19Symptoms and SignsCOVID-19 PandemicCoronavirus Disease 2019Coronavirus Infections

Interventions

Chlorpheniramine Maleate 0.4% Nasal Spray

COMBINATION_PRODUCT

Placebo

COMBINATION_PRODUCT

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Post COVID-19 ConditionPost-COVID-19 Syndrome+4 more

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RECRUITINGPHASE1

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 2, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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