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

NCT ID: NCT05449405

Last Updated: 2023-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-07
• Study Completion Date: 2022-03-11

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Chlorpheniramine Malate (1%) Nasal Spray

Chlorpheniramine Malate (1%) Nasal Spray

Group Type: ACTIVE_COMPARATOR

Chlorpheniramine Maleate 1% Nasal Spray

Intervention Type: COMBINATION_PRODUCT

Chlorpheniramine Maleate 1% Nasal Spray

Placebo Nasal Spray

Placebo Nasal Spray

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: COMBINATION_PRODUCT

Placebo nasal spray

Interventions

Chlorpheniramine Maleate 1% Nasal Spray

Chlorpheniramine Maleate 1% Nasal Spray

Intervention Type: COMBINATION_PRODUCT

Placebo

Placebo nasal spray

Intervention Type: COMBINATION_PRODUCT

Other Intervention Names

ClorNasal; ClorNovir

Eligibility Criteria

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
• Unable to make informed consent or refuse or renounce adherence to standard treatment protocols.
• Any significant illness or drugs that could interfere with study parameters
• Any other condition based on the investigator's clinical judgment does not justify the patient's participation in the study.
• Participation in another clinical trial within the past 30 days
• Clinically significant arrhythmia or symptomatic cardiac conditions including but not limited to QT elongation
• QT interval less than 300 ms or more than 500 ms for both men and women.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital CEMESA Cortés, San Pedro Sula, Honduras

UNKNOWN

Sponsor Role: collaborator

Dr. Ferrer BioPharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital CEMESA

Cortés, San Pedro Sula, Honduras

Countries

Honduras

Other Identifiers

DFB-002

Identifier Type: -

Identifier Source: org_study_id