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Completed

NCT Number: NCT05886829

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

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 (0.4%) for improving clinical recovery in COVID-19 patients. * To assess the efficacy, safety, and tolerability of nasal spray with Chlorpheniramine (0.4%) as an adjunct to the standard of care in reducing hospitalizations and improving clinical recovery in adult patients with mild COVID-19.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Chlorpheniramine Maleate 0.4% Nasal Spray

Combination Product

Chlorpheniramine Maleate 0.4% Nasal Spray

Other names: ClorNasal, ClorNovir

Placebo

Combination Product

Placebo nasal spray

Primary outcomes

  1. Daily symptoms score (DSS)

    Time frame: Baseline through day 7

    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.
  2. Visual Analog Scale (VAS)

    Time frame: Baseline through day 7

    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 outcomes

  1. Hospitalization

    Time frame: Baseline through Day 28

    The proportion of Hospitalizations

  2. Mortality

    Time frame: Baseline through Day 28

    Rate of mortality

  3. The proportion of subjects reporting olfactory function

    Time frame: Baseline through Day 7

    Olfactory function reported on a four-point severity rating scale ranging from 0 to 3.

    0-normal

    • slightly damaged
    • moderately damaged
    • away
  4. The proportion of subjects reporting the presence of upper respiratory symptoms

    Time frame: Baseline through Day 7

    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

Sponsors and collaborators

Lead sponsor

Dr. Ferrer BioPharma

Industry

Collaborators

  • Hospital CEMESA Cortés, San Pedro Sula, Honduras

Registry information

Official study title

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

Acronym: ACCROS-III

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 2, 2023
Registry last updated
Jun 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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