Clinical trial NCT05520944: Accelerating COVID-19 Clinical Recovery in the Outpatient Setting: Retrospective Analysis
Official title: Accelerating COVID-19 Clinical Recovery in the Outpatient Setting: Retrospective Data Collection and Analysis of COVID-19 Patients Treated With ClorNovir® (Chlorpheniramine Maleate (0.4% Nasal Spray)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
COVID-19 Pandemic
COVID-19 Respiratory Infection
SARS CoV 2 Infection
SARS-CoV-2 Acute Respiratory Disease
Lead sponsor: Dr. Ferrer BioPharma
Sponsor class: INDUSTRY
Collaborators: name: Clinica Union Medica Del Norte, S.A.S., Santiago, República Dominicana
First posted: 2022-08-30
Enrollment: 1000
Sex: ALL
Minimum age (years): 6
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: The following are categories of interest in patients with COVID-19 treated with ClorNovir:

* 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.

Eligibility criteria: Inclusion Criteria:

* Male or female patients with a documented diagnosis of SAR-CoV-2
* 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

Exclusion Criteria:

Primary outcomes:
measure: Time to Clinical Recovery
timeFrame: Baseline through Day 10-End of Treatment
measure: Incidence of significant COVID-19-related clinical events
timeFrame: Baseline through Day 10-End of Treatment
measure: Incidence and severity of serious adverse events (SAEs)
timeFrame: Baseline through Day 10-End of Treatment
measure: Incidence and severity of adverse events (AEs) of interest
timeFrame: Baseline through Day 10-End of Treatment
measure: treatment period in the incidence of hospitalizations
timeFrame: Baseline through Day 10-End of Treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Santiago De Los Caballeros
country: Dominican Republic
facility: Clinica Union Medica
Study officials:
References:
citation: 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.
citation: Pocock SJ, Simon R. Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. Biometrics. 1975 Mar;31(1):103-15.
citation: 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.
citation: 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.
citation: 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
citation: 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