Accelerating COVID-19 Clinical Recovery in the Outpatient Setting: Retrospective Analysis
NCT ID: NCT05520944
Last Updated: 2022-08-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1000 participants
OBSERVATIONAL
2021-08-26
2022-10-01
Brief Summary
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Detailed Description
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* Clinical outcomes, as assessed by clinical assessments of clinical symptoms, and incidence of significant clinical events
* Clinical recovery, as assessed by patient-reported outcome measures and clinician-reported outcomes.
The safety objective is to assess the safety and tolerability of ClorNovir.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Retrospective Data Collection
ClorNovir® (Chlorpheniramine) 0.4% Nasal Spray
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.
Interventions
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ClorNovir® (Chlorpheniramine) 0.4% Nasal Spray
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with positive RT-PCR or antigen test for SARS-CoV-2 in nasopharyngeal or oropharyngeal swabs
* Both vaccinated and unvaccinated (high-risk) persons will be included.
* Willing and able to provide written informed consent (ages greater or equal to 18 years) or parental/guardian consent and patient assent (age \<18 years), as required by the IRB or institution or IRB, per local regulations
6 Years
90 Years
ALL
Yes
Sponsors
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Clinica Union Medica Del Norte, S.A.S., Santiago, República Dominicana
UNKNOWN
Dr. Ferrer BioPharma
INDUSTRY
Responsible Party
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Locations
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Clinica Union Medica
Santiago de los Caballeros, , Dominican Republic
Countries
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References
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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.
Pocock SJ, Simon R. Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. Biometrics. 1975 Mar;31(1):103-15.
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.
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.
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
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
Other Identifiers
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DFB-004
Identifier Type: -
Identifier Source: org_study_id
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