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

Primary Purpose

COVID-19, Symptoms and Signs, COVID-19 Pandemic

Status
Completed
Phase
Phase 2
Locations
Honduras
Study Type
Interventional
Intervention
Chlorpheniramine Maleate 1% Nasal Spray
Placebo
Sponsored by
Dr. Ferrer BioPharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Hospital CEMESA

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Chlorpheniramine Malate (1%) Nasal Spray

Placebo Nasal Spray

Arm Description

Chlorpheniramine Malate (1%) Nasal Spray

Placebo Nasal Spray

Outcomes

Primary Outcome Measures

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.
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).

Secondary Outcome Measures

Hospitalization
The proportion of Hospitalizations
Mortality
Rate of mortality
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
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

Full Information

First Posted
July 6, 2022
Last Updated
March 21, 2023
Sponsor
Dr. Ferrer BioPharma
Collaborators
Hospital CEMESA Cortés, San Pedro Sula, Honduras
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1. Study Identification

Unique Protocol Identification Number
NCT05449405
Brief Title
Chlorpheniramine Nasal Spray to Accelerate COVID-19 Clinical Recovery in an Outpatient Setting: ACCROS-I
Acronym
ACCROS-I
Official Title
A Multicentric, Randomized, Double-Blind, Comparative, Prospective, Placebo-controlled, Phase-II/III Clinical Trial (ACCROS-I)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
December 7, 2021 (Actual)
Primary Completion Date
March 11, 2022 (Actual)
Study Completion Date
March 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dr. Ferrer BioPharma
Collaborators
Hospital CEMESA Cortés, San Pedro Sula, Honduras

4. Oversight

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

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Symptoms and Signs, COVID-19 Pandemic, Coronavirus Disease 2019, Coronavirus Infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigator
Allocation
Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chlorpheniramine Malate (1%) Nasal Spray
Arm Type
Active Comparator
Arm Description
Chlorpheniramine Malate (1%) Nasal Spray
Arm Title
Placebo Nasal Spray
Arm Type
Placebo Comparator
Arm Description
Placebo Nasal Spray
Intervention Type
Combination Product
Intervention Name(s)
Chlorpheniramine Maleate 1% Nasal Spray
Other Intervention Name(s)
ClorNasal, ClorNovir
Intervention Description
Chlorpheniramine Maleate 1% Nasal Spray
Intervention Type
Combination Product
Intervention Name(s)
Placebo
Intervention Description
Placebo nasal spray
Primary Outcome Measure Information:
Title
Daily symptoms score (DSS)
Description
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.
Time Frame
Baseline through day 7
Title
Visual Analog Scale (VAS)
Description
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).
Time Frame
Baseline through day 7
Secondary Outcome Measure Information:
Title
Hospitalization
Description
The proportion of Hospitalizations
Time Frame
Baseline through Day 28
Title
Mortality
Description
Rate of mortality
Time Frame
Baseline through Day 28
Title
The proportion of subjects reporting olfactory function
Description
Olfactory function reported on a four-point severity rating scale ranging from 0 to 3. 0-normal slightly damaged moderately damaged away
Time Frame
Baseline through Day 7
Title
The proportion of subjects reporting the presence of upper respiratory symptoms
Description
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
Time Frame
Baseline through Day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Hospital CEMESA
City
Cortés
State/Province
San Pedro Sula
Country
Honduras

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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