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

NCT ID: NCT05520944

Last Updated: 2022-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-26

Study Completion Date

2022-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Retrospective Data Collection

ClorNovir® (Chlorpheniramine) 0.4% Nasal Spray

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Chlorpheniramine Nasal Spray ClorNovir®

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

6 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Clinica Union Medica Del Norte, S.A.S., Santiago, República Dominicana

UNKNOWN

Sponsor Role collaborator

Dr. Ferrer BioPharma

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Clinica Union Medica

Santiago de los Caballeros, , Dominican Republic

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Dominican Republic

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 32539990 (View on PubMed)

Pocock SJ, Simon R. Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. Biometrics. 1975 Mar;31(1):103-15.

Reference Type BACKGROUND
PMID: 1100130 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35652393 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33803811 (View on PubMed)

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

Reference Type 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

Reference Type BACKGROUND

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DFB-004

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

ClariFix Rhinitis RCT
NCT04154605 COMPLETED NA
A Nasal Treatment for COVID-19
NCT05799521 RECRUITING PHASE2