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

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

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.

Study Overview

• Status: Completed
• Conditions: Coronavirus Infections; COVID-19; Coronavirus Disease 2019; COVID-19 Pandemic; Symptoms and Signs
• Intervention / Treatment: Combination product: Chlorpheniramine Maleate 1% Nasal Spray; Combination product: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Honduras
  • San Pedro Sula
    • Cortés, San Pedro Sula, Honduras
      • Hospital CEMESA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Chlorpheniramine Malate (1%) Nasal Spray	Combination product: Chlorpheniramine Maleate 1% Nasal Spray; Chlorpheniramine Maleate 1% Nasal Spray; Other Names: ClorNasal; ClorNovir
Placebo Comparator: Placebo Nasal Spray	Combination product: Placebo; Placebo nasal spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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; = mild symptoms; = moderate symptoms; = severe symptoms.	Baseline through day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospitalization	The proportion of Hospitalizations	Baseline through Day 28
Mortality	Rate of mortality	Baseline through Day 28
The proportion of subjects reporting olfactory function	Olfactory function reported on a four-point severity rating scale ranging from 0 to 3. 0-normal; slightly damaged; moderately damaged; away	Baseline through Day 7
The proportion of subjects reporting the presence of upper respiratory symptoms	The proportion of subjects reporting the presence of upper respiratory symptoms (anosmia, ageusia, cough, and nasal congestion) using a yes or no scale. Yes- Present No- No symptoms present	Baseline through Day 7

Collaborators and Investigators

• Sponsor: Dr. Ferrer BioPharma
• Collaborators: Hospital CEMESA Cortés, San Pedro Sula, Honduras

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2021
• Primary Completion (Actual): March 11, 2022
• Study Completion (Actual): March 11, 2022

Study Registration Dates

• First Submitted: July 6, 2022
• First Submitted That Met QC Criteria: July 6, 2022
• First Posted (Actual): July 8, 2022

Study Record Updates

• Last Update Posted (Actual): March 23, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Coronavirus Infections; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Dermatologic Agents; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Antipruritics; Chlorpheniramine
• Other Study ID Numbers: DFB-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes