COVID-19ACCROS-RNCT05520944
Accelerating COVID-19 Clinical Recovery in the Outpatient Setting: Retrospective Analysis
An observational study of COVID-19 and COVID-19 Pandemic, run by Dr. Ferrer BioPharma at 1 site in Dominican Republic.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19, COVID-19 Pandemic, COVID-19 Respiratory Infection
- What is being tested?
- ClorNovir® (Chlorpheniramine) 0.4% Nasal Spray
- How many people
- 1,000 participants
- Where
- 1 siteDominican Republic
- Study dates
- 26 Aug 2021to 1 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Dominican Republic1 site
Clinica Union Medica
Santiago de los Caballeros
About this study
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 (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.
Read the 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
- Being tested
- ClorNovir® (Chlorpheniramine) 0.4% Nasal Spray
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClorNovir® (Chlorpheniramine) 0.4% Nasal SprayDrug
Also called Chlorpheniramine Nasal Spray, ClorNovir®
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.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective Data Collection | Not described Receives: Drug: ClorNovir® (Chlorpheniramine) 0.4% Nasal Spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline through Day 10-End of Treatment
Incidence of significant COVID-19-related clinical events
Such as anosmia, dysgeusia, cough, and nasal congestion.
Measured: Baseline through Day 10-End of Treatment
Incidence and severity of serious adverse events (SAEs)
Measured: 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
Measured: Baseline through Day 10-End of Treatment
treatment period in the incidence of hospitalizations
Measured: Baseline through Day 10-End of Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study start26 Aug 2021
- Primary completion30 Sep 2022 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Ferrer BioPharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinica Union Medica Del Norte, S.A.S., Santiago, República Dominicana
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05520944
- Sponsor's protocol ID
- DFB-004
- Acronym
- ACCROS-R
- Status last verified
- Aug 2022
- First submitted
- 27 Aug 2022
- Last updated
- 30 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
WHO Working Group on the Clinical Characterisation and Management of COVID-19 infection. A minimal common outcome measure set for COVID-19 clinical research. Lancet Infect Dis. 2020 Aug;20(8):e192-e197. doi: 10.1016/S1473-3099(20)30483-7. Epub 2020 Jun 12.
PubMed 32539990Pocock SJ, Simon R. Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. Biometrics. 1975 Mar;31(1):103-15.
PubMed 1100130Rizvi SAA, Ferrer G, Khawaja UA, Sanchez-Gonzalez MA. Chlorpheniramine, an Old Drug with New Potential Clinical Applications: A Comprehensive Review of the Literature. Curr Rev Clin Exp Pharmacol. 2024;19(2):137-145. doi: 10.2174/2772432817666220601162006.
PubMed 35652393Taha MA, Hall CA, Shortess CJ, Rathbone RF, Barham HP. Treatment Protocol for COVID-19 Based on T2R Phenotype. Viruses. 2021 Mar 18;13(3):503. doi: 10.3390/v13030503.
PubMed 33803811Sanchez-Gonzalez, M. A., Westover, J. B., Rizvi, S. A. A., Torres, J., & Ferrer, G. A. (2022). Intranasal Chlorpheniramine Maleate for the treatment of COVID-19: Translational and Clinical Evidence. Medical Research Archives, 10(3). https://doi.org/10.18103/mra.v10i3.2752
Torres, J., Go, C., Camacho, G., Sanchez-Gonzalez, M., & Ferrer, G. (2021). Chlorpheniramine Maleate Nasal Spray In COVID-19 Patients: Case Series. J Clin Exp Pharmacol, 10(2), 3. https://doi.org/10.35248/2161-1459.21.10.275
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 (0.4% Nasal Spray)
- ClinicalTrials.gov ID
- NCT05520944
- Acronym / sponsor ID
- ACCROS-R / DFB-004
- Conditions
- COVID-19, COVID-19 Pandemic, COVID-19 Respiratory Infection, SARS CoV 2 Infection, SARS-CoV-2 Acute Respiratory Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Dr. Ferrer BioPharmaIndustry (pharma, biotech, devices)
- Collaborators
- Clinica Union Medica Del Norte, S.A.S., Santiago, República Dominicana
- Study start
- 26 Aug 2021 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 30 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Retrospective Data Collection | – | Drug: ClorNovir® (Chlorpheniramine) 0.4% Nasal Spray |
Who may qualify
- Ages
- 6 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ClorNovir® (Chlorpheniramine) 0.4% Nasal SprayAlso: Chlorpheniramine Nasal Spray, ClorNovir®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. | Drug | Retrospective Data Collection |
Primary outcome
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).
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.
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
Time frame: Baseline through Day 10-End of Treatment
Such as irritation in the nasal fossa, Headache, Epistaxis, modification or discontinuation
treatment period in the incidence of hospitalizations
Time frame: Baseline through Day 10-End of Treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2022.
- Background: PubMed 32539990WHO Working Group on the Clinical Characterisation and Management of COVID-19 infection. A minimal common outcome measure set for COVID-19 clinical research. Lancet Infect Dis. 2020 Aug;20(8):e192-e197. doi: 10.1016/S1473-3099(20)30483-7. Epub 2020 Jun 12.
- Background: PubMed 1100130Pocock SJ, Simon R. Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. Biometrics. 1975 Mar;31(1):103-15.
- Background: PubMed 35652393Rizvi SAA, Ferrer G, Khawaja UA, Sanchez-Gonzalez MA. Chlorpheniramine, an Old Drug with New Potential Clinical Applications: A Comprehensive Review of the Literature. Curr Rev Clin Exp Pharmacol. 2024;19(2):137-145. doi: 10.2174/2772432817666220601162006.
- Background: PubMed 33803811Taha MA, Hall CA, Shortess CJ, Rathbone RF, Barham HP. Treatment Protocol for COVID-19 Based on T2R Phenotype. Viruses. 2021 Mar 18;13(3):503. doi: 10.3390/v13030503.
- BackgroundSanchez-Gonzalez, M. A., Westover, J. B., Rizvi, S. A. A., Torres, J., & Ferrer, G. A. (2022). Intranasal Chlorpheniramine Maleate for the treatment of COVID-19: Translational and Clinical Evidence. Medical Research Archives, 10(3). https://doi.org/10.18103/mra.v10i3.2752
- BackgroundTorres, J., Go, C., Camacho, G., Sanchez-Gonzalez, M., & Ferrer, G. (2021). Chlorpheniramine Maleate Nasal Spray In COVID-19 Patients: Case Series. J Clin Exp Pharmacol, 10(2), 3. https://doi.org/10.35248/2161-1459.21.10.275
- Individual participant dataSharing planned: Undecided
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and COVID-19 Pandemic, run by Dr. Ferrer BioPharma at 1 site in Dominican Republic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Dominican Republic. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Clinical Recovery (time frame: Baseline through Day 10-End of Treatment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05520944, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2022.