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

Dr. Ferrer BioPharma

Status: Active, not recruiting

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

Treatments: Drug: ClorNovir® (Chlorpheniramine) 0.4% Nasal Spray

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT05520944

DFB-004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 6 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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:

Trial design

1,000 participants in 1 patient group

Retrospective Data Collection

Treatment:

Drug: ClorNovir® (Chlorpheniramine) 0.4% Nasal Spray