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

Study Overview
=================
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.

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)

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

Intervention / Treatment
-----------------
* Drug: ClorNovir® (Chlorpheniramine) 0.4% Nasal Spray


Participation Criteria
=================
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:

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Retrospective Data Collection<br> | Drug: ClorNovir® (Chlorpheniramine) 0.4% Nasal Spray<br>* 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.<br>* Other names: ClorNovir®;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |