Trials / Unknown
UnknownNCT05520944
Accelerating COVID-19 Clinical Recovery in the Outpatient Setting: Retrospective Analysis
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)
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,000 (estimated)
- Sponsor
- Dr. Ferrer BioPharma · Industry
- Sex
- All
- Age
- 6 Years – 90 Years
- Healthy volunteers
- Accepted
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.
Conditions
- COVID-19
- COVID-19 Pandemic
- COVID-19 Respiratory Infection
- SARS CoV 2 Infection
- SARS-CoV-2 Acute Respiratory Disease
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2021-08-26
- Primary completion
- 2022-09-30
- Completion
- 2022-10-01
- First posted
- 2022-08-30
- Last updated
- 2022-08-30
Locations
1 site across 1 country: Dominican Republic
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05520944. Inclusion in this directory is not an endorsement.