Clinical trial NCT05449405: Chlorpheniramine Nasal Spray to Accelerate COVID-19 Clinical Recovery in an Outpatient Setting: ACCROS-I
Official title: A Multicentric, Randomized, Double-Blind, Comparative, Prospective, Placebo-controlled, Phase-II/III Clinical Trial (ACCROS-I)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: COVID-19
Symptoms and Signs
COVID-19 Pandemic
Coronavirus Disease 2019
Coronavirus Infections
Lead sponsor: Dr. Ferrer BioPharma
Sponsor class: INDUSTRY
Collaborators: name: Hospital CEMESA Cortés, San Pedro Sula, Honduras
First posted: 2022-07-08
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Daily symptoms score (DSS)
timeFrame: Baseline through day 7
measure: Visual Analog Scale (VAS)
timeFrame: Baseline through day 7
Secondary outcomes:
measure: Hospitalization
timeFrame: Baseline through Day 28
measure: Mortality
timeFrame: Baseline through Day 28
measure: The proportion of subjects reporting olfactory function
timeFrame: Baseline through Day 7
measure: The proportion of subjects reporting the presence of upper respiratory symptoms
timeFrame: Baseline through Day 7
Other outcomes:
Locations:
city: Cortés
country: Honduras
facility: Hospital CEMESA
state: San Pedro Sula
Study officials:
References: