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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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COVID-19, Symptoms and Signs, COVID-19 Pandemic, Coronavirus Disease 2019, Coronavirus Infections

Intervention / Treatment
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* Combination Product: Chlorpheniramine Maleate 1% Nasal Spray
* Combination Product: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Chlorpheniramine Malate (1%) Nasal Spray<br>Chlorpheniramine Malate (1%) Nasal Spray | Combination Product: Chlorpheniramine Maleate 1% Nasal Spray<br>* Chlorpheniramine Maleate 1% Nasal Spray<br>* Other names: ClorNovir;|
| Placebo Comparator: Placebo Nasal Spray<br>Placebo Nasal Spray | Combination Product: Placebo<br>* Placebo nasal spray<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 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 |