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.
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 Type
OBSERVATIONAL
Enrollment
1,000
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.
Clinica Union Medica
Santiago de los Caballeros, Dominican Republic
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).
Time frame: Baseline through Day 10-End of Treatment
Incidence of significant COVID-19-related clinical events
Such as anosmia, dysgeusia, cough, and nasal congestion.
Time frame: Baseline through Day 10-End of Treatment
Incidence and severity of serious adverse events (SAEs)
Time frame: 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
Time frame: Baseline through Day 10-End of Treatment
treatment period in the incidence of hospitalizations
Time frame: Baseline through Day 10-End of Treatment
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