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

NCT05886829 | Completed Phase 2 FDA Drug FDA Device

• 1 other identifier: DFB-006
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 1

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 (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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Daily symptoms score (DSS)

  Change from baseline daily symptoms score (DSS) to day 7 The DSS is an instrument comprised of a four-point severity rating scale ranging from 0 to 3. 0 = no symptoms 1. = mild symptoms 2. = moderate symptoms 3. = severe symptoms.

  Baseline through day 7

• Visual Analog Scale (VAS)

  Change from baseline visual analog scale (VAS) to day 7 The VAS is a quantitative method that evaluates the severity of symptoms on a scale of 1-10 (no signs to worst symptoms). A 10 cm line is used to grade the severity of symptoms from "no symptoms" (0 cm) to "the highest level of symptoms" (10 cm).

  Baseline through day 7

Secondary Outcomes (4)

• Hospitalization

  Baseline through Day 28

• Mortality

  Baseline through Day 28

• The proportion of subjects reporting olfactory function

  Baseline through Day 7

• The proportion of subjects reporting the presence of upper respiratory symptoms

  Baseline through Day 7

Study Arms (2)

Chlorpheniramine Malate (0.4%) Nasal Spray

ACTIVE COMPARATOR

Chlorpheniramine Malate (0.4%) Nasal Spray

Combination Product: Chlorpheniramine Maleate 0.4% Nasal Spray

Placebo Nasal Spray

PLACEBO COMPARATOR

Placebo Nasal Spray

Combination Product: Placebo

Interventions

Chlorpheniramine Maleate 0.4% Nasal Spray COMBINATION_PRODUCT

Chlorpheniramine Maleate 0.4% Nasal Spray

Also known as: ClorNasal, ClorNovir

Chlorpheniramine Malate (0.4%) Nasal Spray

Placebo COMBINATION_PRODUCT

Placebo nasal spray

Placebo Nasal Spray

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \< 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

Sponsors & Collaborators

• Dr. Ferrer BioPharma: lead
• Hospital CEMESA Cortés, San Pedro Sula, Honduras: collaborator

Study Sites (1)

Hospital CEMESA

Cortés, San Pedro Sula, Honduras

Location

MeSH Terms

Conditions

COVID-19; Signs and Symptoms; Coronavirus Infections

Interventions

Chlorpheniramine; Nasal Sprays

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pheniramine; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Aerosols; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a multi-center, Phase 2/3 Study to evaluate the efficacy and safety of nasally administered CPM in subjects with symptomatic COVID-19 with a positive PCR test.

Study Record Dates

• First Submitted: June 1, 2023
• First Posted: June 2, 2023
• Study Start: July 27, 2022
• Primary Completion: January 19, 2023
• Study Completion: February 1, 2023
• Last Updated: June 2, 2023

Record last verified: 2023-06

Locations

HO (1)