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

NCT05520944 | Unknown DMC FDA Drug

• 1 other identifier: DFB-004
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; COVID-19 Pandemic; COVID-19 Respiratory Infection; SARS CoV 2 Infection; SARS-CoV-2 Acute Respiratory Disease

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (1)

Retrospective Data Collection

Drug: ClorNovir® (Chlorpheniramine) 0.4% Nasal Spray

Interventions

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.

Also known as: Chlorpheniramine Nasal Spray, ClorNovir®

Retrospective Data Collection

Eligibility Criteria

• Age: 6 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

Sponsors & Collaborators

• Dr. Ferrer BioPharma: lead
• Clinica Union Medica Del Norte, S.A.S., Santiago, República Dominicana: collaborator

Study Sites (1)

Clinica Union Medica

Santiago de los Caballeros, Dominican Republic

Location

Related Publications (6)

• 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.

  PMID: 32539990 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.

  PMID: 1100130 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.

  PMID: 35652393 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.

  PMID: 33803811 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

  BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

Chlorpheniramine; Nasal Sprays

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pheniramine; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Aerosols; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2022
• First Posted: August 30, 2022
• Study Start: August 26, 2021
• Primary Completion: September 30, 2022
• Study Completion: October 1, 2022
• Last Updated: August 30, 2022

Record last verified: 2022-08

Locations

DO (1)