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

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.

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.