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

• Status: Completed
• Trial end date: 2022-03-11
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Dr. Ferrer BioPharma
• Collaborator: Hospital CEMESA Cortés, San Pedro Sula, Honduras
• Treatments: Chlorpheniramine

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.