Chlorpheniramine Nasal Spray to Accelerate COVID-19 Clinical Recovery in an Outpatient Setting: ACCROS-I
NCT05449405 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 101
Last updated 2023-03-23
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.
Conditions
- COVID-19
- Symptoms and Signs
- COVID-19 Pandemic
- Coronavirus Disease 2019
- Coronavirus Infections
Interventions
- COMBINATION_PRODUCT
-
Chlorpheniramine Maleate 1% Nasal Spray
Chlorpheniramine Maleate 1% Nasal Spray
- COMBINATION_PRODUCT
-
Placebo
Placebo nasal spray
Sponsors & Collaborators
-
Hospital CEMESA Cortés, San Pedro Sula, Honduras
collaborator UNKNOWN -
Dr. Ferrer BioPharma
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-12-07
- Primary Completion
- 2022-03-11
- Completion
- 2022-03-11
- FDA Drug
- Yes
- FDA Device
- Yes
Countries
- Honduras
Study Locations
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