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

Dr. Ferrer BioPharma

Status and phase

Completed

Phase 3

Phase 2

Conditions

COVID-19

Symptoms and Signs

Coronavirus Disease 2019

Coronavirus Infections

COVID-19 Pandemic

Treatments

Combination Product: Placebo

Combination Product: Chlorpheniramine Maleate 1% Nasal Spray

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT05449405

DFB-002

Details and patient eligibility

About

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.

Full 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.

Enrollment

101 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.