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| Name | Class |
|---|---|
| Hospital CEMESA Cortés, San Pedro Sula, Honduras | UNKNOWN |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chlorpheniramine Malate (1%) Nasal Spray | Active Comparator | Chlorpheniramine Malate (1%) Nasal Spray |
|
| Placebo Nasal Spray | Placebo Comparator | Placebo Nasal Spray |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chlorpheniramine Maleate 1% Nasal Spray | Combination Product | Chlorpheniramine Maleate 1% Nasal Spray |
|
| Measure | Description | Time Frame |
|---|---|---|
| Daily symptoms score (DSS) | 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
| Baseline through day 7 |
| Visual Analog Scale (VAS) | 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). | Baseline through day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Hospitalization | The proportion of Hospitalizations | Baseline through Day 28 |
| Mortality | Rate of mortality | Baseline through Day 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital CEMESA | Cortés | San Pedro Sula | Honduras |
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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.
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| Placebo | Combination Product | Placebo nasal spray |
|
| The proportion of subjects reporting olfactory function | Olfactory function reported on a four-point severity rating scale ranging from 0 to 3. 0-normal
| Baseline through Day 7 |
| The proportion of subjects reporting the presence of upper respiratory symptoms | 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 | Baseline through Day 7 |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D012816 | Signs and Symptoms |
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002744 | Chlorpheniramine |
| D059085 | Nasal Sprays |
| ID | Term |
|---|---|
| D010632 | Pheniramine |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000336 | Aerosols |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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