Ignite Creation Date:
2024-05-06 @ 6:02 PM
Last Modification Date:
2024-10-26 @ 2:40 PM
Study NCT ID:
NCT05520944
Status:
UNKNOWN
Last Update Posted:
2022-08-30
First Post:
2022-08-27
Brief Title:
Accelerating COVID-19 Clinical Recovery in the Outpatient Setting Retrospective Analysis
Sponsor:
Dr Ferrer BioPharma
Organization:
Dr Ferrer BioPharma
Study Overview
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 04 Nasal Spray
Status:
UNKNOWN
Status Verified Date:
2022-08
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACCROS-R
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None