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

• Conditions: COVID-19 Pandemic; COVID-19 Respiratory Infection; SARS-CoV-2 Acute Respiratory Disease; COVID-19; SARS CoV 2 Infection
• Interventions: Drug: ClorNovir® (Chlorpheniramine) 0.4% Nasal Spray

• Registration Number: NCT05520944
• Lead Sponsor: Dr. Ferrer BioPharma

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.

Study Timeline

• Study Start: 2021-08-26
• Status Verified: 2022-08
• Study First Submitted: 2022-08-27
• Study First Submitted QC: 2022-08-27
• Last Update Submitted: 2022-08-27
• Study First Posted: 2022-08-30
• Last Update Posted: 2022-08-30
• Primary Completion: 2022-09-30
• Study Completion: 2022-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Retrospective Data Collection	ClorNovir® (Chlorpheniramine) 0.4% Nasal Spray	-

Primary Outcome Measures

Name	Time	Method
Incidence of significant COVID-19-related clinical events	Baseline through Day 10-End of Treatment	Such as anosmia, dysgeusia, cough, and nasal congestion.
Incidence and severity of adverse events (AEs) of interest	Baseline through Day 10-End of Treatment	Such as irritation in the nasal fossa, Headache, Epistaxis, modification or discontinuation
Time to Clinical Recovery	Baseline through Day 10-End of Treatment	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).
Incidence and severity of serious adverse events (SAEs)	Baseline through Day 10-End of Treatment
treatment period in the incidence of hospitalizations	Baseline through Day 10-End of Treatment

Trial Locations

Locations (1)

Clinica Union Medica; 🇩🇴 Santiago De Los Caballeros, Dominican Republic