Accelerating COVID-19 Clinical Recovery in the Outpatient Setting: Retrospective Analysis (ACCROS-R)

August 27, 2022 updated by: Dr. Ferrer BioPharma

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)

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 90 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients at the study site who have been treated with ClorNovir and was COVID-19 positive will be considered for inclusion in this study.

Description

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:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Retrospective Data Collection
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.
Other Names:
  • Chlorpheniramine Nasal Spray
  • ClorNovir®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Clinical Recovery
Time Frame: 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).
Baseline through Day 10-End of Treatment
Incidence of significant COVID-19-related clinical events
Time Frame: Baseline through Day 10-End of Treatment
Such as anosmia, dysgeusia, cough, and nasal congestion.
Baseline through Day 10-End of Treatment
Incidence and severity of serious adverse events (SAEs)
Time Frame: Baseline through Day 10-End of Treatment
Baseline through Day 10-End of Treatment
Incidence and severity of adverse events (AEs) of interest
Time Frame: Baseline through Day 10-End of Treatment
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
Time Frame: Baseline through Day 10-End of Treatment
Baseline through Day 10-End of Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Ferrer BioPharma

Collaborators

Clinica Union Medica Del Norte, S.A.S., Santiago, República Dominicana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 26, 2021

Primary Completion (Anticipated)

September 30, 2022

Study Completion (Anticipated)

October 1, 2022

Study Registration Dates

First Submitted

August 27, 2022

First Submitted That Met QC Criteria

August 27, 2022

First Posted (Actual)

August 30, 2022

Study Record Updates

Last Update Posted (Actual)

August 30, 2022

Last Update Submitted That Met QC Criteria

August 27, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DFB-004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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