Hospital CEMESA
Cortés, San Pedro Sula, Honduras
NCT Number: NCT05886829
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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Notify Me18 year–65 year
All sexes
Interventional
Phase 2 / Phase 3
Cortés, San Pedro Sula, Honduras
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Chlorpheniramine Maleate 0.4% Nasal Spray
Other names: ClorNasal, ClorNovir
Placebo nasal spray
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
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).
Time frame: Baseline through Day 28
The proportion of Hospitalizations
Time frame: Baseline through Day 28
Rate of mortality
Time frame: Baseline through Day 7
Olfactory function reported on a four-point severity rating scale ranging from 0 to 3.
0-normal
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
Dr. Ferrer BioPharma
Industry
A Multicentric, Randomized, Double-Blind, Comparative, Prospective, Placebo-controlled, Phase-II/III Clinical Trial (ACCROS-III)
Acronym: ACCROS-III
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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