Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Clinica Union Medica Del Norte, S.A.S., Santiago, República Dominicana | UNKNOWN |
Not provided
Not provided
Not provided
The purpose of this retrospective study is to evaluate the effectiveness of CPM nasal spray as part of the treatment of COVID-19 and its impact on clinical symptoms. Two cohort groups will be compared (CPM vs. standard care). The hypothesis to be tested is that patients treated with CPM nasal spray showed more rapid clinical improvement than those treated with standard of care alone. Clinical improvement will be evaluated by the total number of days with the manifestation of COVID-19 symptoms, including cough, nasal congestion, ageusia, and anosmia, among others. The rate of hospitalization between the cohorts will also be evaluated.
The following are categories of interest in patients with COVID-19 treated with ClorNovir:
The safety objective is to assess the safety and tolerability of ClorNovir.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retrospective Data Collection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ClorNovir® (Chlorpheniramine) 0.4% Nasal Spray | Drug | Patients will have received treatment with ClorNovir® as prescribed by their physician at the approved dose per local prescribing information, as part of their COVID-19 clinical recovery. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Clinical Recovery | Defined as the change from baseline to end of treatment in COVID-19 symptoms on a 10-item ordinal scale* ("A minimal common outcome measure set for COVID-19 clinical research," 2020). | Baseline through Day 10-End of Treatment |
| Incidence of significant COVID-19-related clinical events | Such as anosmia, dysgeusia, cough, and nasal congestion. | Baseline through Day 10-End of Treatment |
| Incidence and severity of serious adverse events (SAEs) | Baseline through Day 10-End of Treatment | |
| Incidence and severity of adverse events (AEs) of interest | Such as irritation in the nasal fossa, Headache, Epistaxis, modification or discontinuation | Baseline through Day 10-End of Treatment |
| treatment period in the incidence of hospitalizations | Baseline through Day 10-End of Treatment |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
All patients at the study site who have been treated with ClorNovir and was COVID-19 positive will be considered for inclusion in this study.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Union Medica | Santiago de los Caballeros | Dominican Republic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32539990 | Background | WHO Working Group on the Clinical Characterisation and Management of COVID-19 infection. A minimal common outcome measure set for COVID-19 clinical research. Lancet Infect Dis. 2020 Aug;20(8):e192-e197. doi: 10.1016/S1473-3099(20)30483-7. Epub 2020 Jun 12. | |
| 1100130 | Background | Pocock SJ, Simon R. Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. Biometrics. 1975 Mar;31(1):103-15. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 35652393 | Background | Rizvi SAA, Ferrer G, Khawaja UA, Sanchez-Gonzalez MA. Chlorpheniramine, an Old Drug with New Potential Clinical Applications: A Comprehensive Review of the Literature. Curr Rev Clin Exp Pharmacol. 2024;19(2):137-145. doi: 10.2174/2772432817666220601162006. |
| 33803811 | Background | Taha MA, Hall CA, Shortess CJ, Rathbone RF, Barham HP. Treatment Protocol for COVID-19 Based on T2R Phenotype. Viruses. 2021 Mar 18;13(3):503. doi: 10.3390/v13030503. |
| Background | Sanchez-Gonzalez, M. A., Westover, J. B., Rizvi, S. A. A., Torres, J., & Ferrer, G. A. (2022). Intranasal Chlorpheniramine Maleate for the treatment of COVID-19: Translational and Clinical Evidence. Medical Research Archives, 10(3). https://doi.org/10.18103/mra.v10i3.2752 |
| Background | Torres, J., Go, C., Camacho, G., Sanchez-Gonzalez, M., & Ferrer, G. (2021). Chlorpheniramine Maleate Nasal Spray In COVID-19 Patients: Case Series. J Clin Exp Pharmacol, 10(2), 3. https://doi.org/10.35248/2161-1459.21.10.275 |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| 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 |
Not provided
Not provided