Accelerating COVID-19 Clinical Recovery in the Outpatient Setting: Retrospective Analysis

COVID-19 Clinical Trial

— ACCROS-R  

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05520944
• Other study ID #: DFB-004
• Status: Active, not recruiting
• Start date: August 26, 2021
• Est. completion date: October 1, 2022

Study information

• Verified date: August 2022
• Source: Dr. Ferrer BioPharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1000
• Est. completion date: October 1, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 90 Years

Eligibility

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:

Related Conditions & MeSH terms

• Communicable Diseases
• COVID-19
• COVID-19 Pandemic
• Infections
• Respiration Disorders
• Respiratory Tract Diseases
• Respiratory Tract Infections
• SARS-CoV-2 Acute Respiratory Disease

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Dominican Republic	Clinica Union Medica	Santiago De Los Caballeros

Sponsors (2)

Lead Sponsor	Collaborator
Dr. Ferrer BioPharma	Clinica Union Medica Del Norte, S.A.S., Santiago, República Dominicana

Country where clinical trial is conducted

Dominican Republic, 

References & Publications (6)

Pocock SJ, Simon R. Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. Biometrics. 1975 Mar;31(1):103-15. — View 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. 2022 Jun 1. doi: 10.2174/2772432817666220601162006. [Epub ahead of print] — View 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

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). pii: 503. doi: 10.3390/v13030503. — View 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

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. Review. Erratum in: Lancet Infect Dis. 2020 Oct;20(10):e250. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Incidence of significant COVID-19-related clinical events	Such as anosmia, dysgeusia, cough, and nasal congestion.	Baseline through Day 10-End of Treatment
Primary	Incidence and severity of serious adverse events (SAEs)		Baseline through Day 10-End of Treatment
Primary	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
Primary	treatment period in the incidence of hospitalizations		Baseline through Day 10-End of Treatment