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

COVID-19 Clinical Trial

— ACCROS-I  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05449405
• Other study ID #: DFB-002
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: December 7, 2021
• Est. completion date: March 11, 2022

Study information

• Verified date: March 2023
• Source: Dr. Ferrer BioPharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: March 11, 2022
• Est. primary completion date: March 11, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Combination Product:
• Chlorpheniramine Maleate 1% Nasal Spray
Chlorpheniramine Maleate 1% Nasal Spray
• Placebo
Placebo nasal spray

Locations

Country	Name	City	State
Honduras	Hospital CEMESA	Cortés	San Pedro Sula

Sponsors (2)

Lead Sponsor	Collaborator
Dr. Ferrer BioPharma	Hospital CEMESA Cortés, San Pedro Sula, Honduras

Country where clinical trial is conducted

Honduras, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Hospitalization	The proportion of Hospitalizations	Baseline through Day 28
Secondary	Mortality	Rate of mortality	Baseline through Day 28
Secondary	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
Secondary	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