COVID-19Phase 2/3ACCROS-INCT05449405
Chlorpheniramine Nasal Spray to Accelerate COVID-19 Clinical Recovery in an Outpatient Setting: ACCROS-I
A Phase 2/3 study testing Chlorpheniramine Maleate 1% Nasal Spray in people with COVID-19 and Symptoms and Signs, run by Dr. Ferrer BioPharma at 1 site in Honduras.
Trial summary
The goal of this clinical trial is to examine the effectiveness of intranasal-administered Chlorpheniramine Maleate in COVID-19-positive participants as part of early treatment for COVID-19. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Symptoms and Signs, COVID-19 Pandemic
- What is being tested?
- Chlorpheniramine Maleate 1% Nasal Spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 101 participants
- Where
- 1 siteHonduras
- Study dates
- 7 Dec 2021to 11 Mar 2022
- Phase
- Phase 2/3
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female patients between 18 and 65 years (both inclusive)
- Patients with positive RT-PCR test for SARS-CoV-2 in nasopharyngeal or oropharyngeal swabs (sample collected or proof of positive test ≤3 days before randomization)
- Patients with mild COVID-19 have the following symptoms and signs prior to randomization (≤ 3days)
- Upper respiratory tract symptoms (\&/or fever) without shortness of breath or hypoxia. (SpO2 > 94 %)
- Willingness to sign written informed consent document
Who cannot join
- < 18 years of age
- Hospitalized patients
- Subject with known allergy or hypersensitivity to the components of the formulation.
- Patients receiving therapy with Monoamine oxidase inhibitors (MAOIs): rasagline, selegiline, isocarbonboxasid, phenelzine, tranylcypromine.
- Patients with narrow-angle glaucoma
- urinary retention
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- Sleep Apnea
- History of immunodeficiency or receiving immunosuppressive therapy.
- Patients with acute exacerbation of severe comorbidities such as chronic obstructive pulmonary disease (COPD), class 3 and 4 heart failure diagnosed according to the criteria of the New York Heart Failure Association (NYHA), or diseases with severe oxygenation problems
- Any Surgical procedure in the past 12 weeks
- Unable to make informed consent or refuse or renounce adherence to standard treatment protocols.
- Any significant illness or drugs that could interfere with study parameters
- Any other condition based on the investigator's clinical judgment does not justify the patient's participation in the study.
- Participation in another clinical trial within the past 30 days
- Clinically significant arrhythmia or symptomatic cardiac conditions including but not limited to QT elongation
- QT interval less than 300 ms or more than 500 ms for both men and women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicentric, Randomized, Double-Blind, Comparative, Prospective, Placebo-controlled, Phase-II/III Clinical Trial (ACCROS-I)
The goal of this clinical trial is to examine the effectiveness of intranasal-administered Chlorpheniramine Maleate in COVID-19-positive participants as part of early treatment for COVID-19. The main questions it aims to answer are:
- To assess the efficacy of nasal spray with Chlorpheniramine (1.0%) for improving clinical recovery in COVID-19 patients.
- To assess the efficacy, safety, and tolerability of nasal spray with Chlorpheniramine (1%) as an adjunct to the standard of care in reducing hospitalizations and improving clinical recovery in adult patients with mild COVID-19.
Read the detailed description
The main goal of the present study is to examine the effectiveness of CPM intranasal spray as part of early treatment for COVID-19. The study will test the hypothesis that intranasal CPM would accelerate clinical recovery, particularly the alleviation of sensory symptoms and URS, in patients with COVID-19.
- Conditions
- COVID-19, Symptoms and Signs, COVID-19 Pandemic, Coronavirus Disease 2019, Coronavirus Infections
- Being tested
- Chlorpheniramine Maleate 1% Nasal Spray, Placebo
- Medical subject headings
- COVID-19, Signs and Symptoms, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorpheniramine Maleate 1% Nasal SprayCombination product
Also called ClorNasal, ClorNovir
Chlorpheniramine Maleate 1% Nasal Spray
PlaceboCombination product
Placebo nasal spray
| Study group | Role | What they receive |
|---|---|---|
| Chlorpheniramine Malate (1%) Nasal Spray | Active comparator | Chlorpheniramine Malate (1%) Nasal Spray Receives: Combination Product: Chlorpheniramine Maleate 1% Nasal Spray |
| Placebo Nasal Spray | Placebo comparator | Placebo Nasal Spray Receives: Combination Product: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily symptoms score (DSS)
Change from baseline daily symptoms score (DSS) to day 7
The DSS is an instrument comprised of a four-point severity rating scale ranging from 0 to 3.
0 = no symptoms
- = mild symptoms
- = moderate symptoms
- = severe symptoms.
Measured: Baseline through day 7
Visual Analog Scale (VAS)
Change from baseline visual analog scale (VAS) to day 7
The VAS is a quantitative method that evaluates the severity of symptoms on a scale of 1-10 (no signs to worst symptoms). A 10 cm line is used to grade the severity of symptoms from "no symptoms" (0 cm) to "the highest level of symptoms" (10 cm).
Measured: Baseline through day 7
Secondary outcomes (4)
Hospitalization
The proportion of Hospitalizations
Measured: Baseline through Day 28
Mortality
Rate of mortality
Measured: Baseline through Day 28
The proportion of subjects reporting olfactory function
Olfactory function reported on a four-point severity rating scale ranging from 0 to 3.
0-normal
- slightly damaged
- moderately damaged
- away
Measured: Baseline through Day 7
The proportion of subjects reporting the presence of upper respiratory symptoms
The proportion of subjects reporting the presence of upper respiratory symptoms (anosmia, ageusia, cough, and nasal congestion) using a yes or no scale.
Yes- Present No- No symptoms present
Measured: Baseline through Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study start7 Dec 2021
- Primary completion11 Mar 2022
- Study completion11 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a multi-center, Phase 2/3 Study to evaluate the efficacy and safety of nasally administered CPM in subjects with symptomatic COVID-19 with a positive PCR test.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Ferrer BioPharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital CEMESA Cortés, San Pedro Sula, Honduras
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05449405
- Sponsor's protocol ID
- DFB-002
- Acronym
- ACCROS-I
- Status last verified
- Mar 2023
- First submitted
- 6 Jul 2022
- Last updated
- 23 Mar 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentric, Randomized, Double-Blind, Comparative, Prospective, Placebo-controlled, Phase-II/III Clinical Trial (ACCROS-I)
- ClinicalTrials.gov ID
- NCT05449405
- Acronym / sponsor ID
- ACCROS-I / DFB-002
- Conditions
- COVID-19, Symptoms and Signs, COVID-19 Pandemic, Coronavirus Disease 2019, Coronavirus Infections
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Dr. Ferrer BioPharmaIndustry (pharma, biotech, devices)
- Collaborators
- Hospital CEMESA Cortés, San Pedro Sula, Honduras
- Study start
- 7 Dec 2021 (actual)
- Primary completion
- 11 Mar 2022 (actual)
- Study completion
- 11 Mar 2022 (actual)
- First posted
- 8 Jul 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 goal of this clinical trial is to examine the effectiveness of intranasal-administered Chlorpheniramine Maleate in COVID-19-positive participants as part of early treatment for COVID-19. The main questions it aims to answer are:
- To assess the efficacy of nasal spray with Chlorpheniramine (1.0%) for improving clinical recovery in COVID-19 patients.
- To assess the efficacy, safety, and tolerability of nasal spray with Chlorpheniramine (1%) as an adjunct to the standard of care in reducing hospitalizations and improving clinical recovery in adult patients with mild COVID-19.
Detailed description
The main goal of the present study is to examine the effectiveness of CPM intranasal spray as part of early treatment for COVID-19. The study will test the hypothesis that intranasal CPM would accelerate clinical recovery, particularly the alleviation of sensory symptoms and URS, in patients with COVID-19.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is a multi-center, Phase 2/3 Study to evaluate the efficacy and safety of nasally administered CPM in subjects with symptomatic COVID-19 with a positive PCR test.
| Arm | Type | Receives |
|---|---|---|
| Chlorpheniramine Malate (1%) Nasal Spray | Active comparator | Combination Product: Chlorpheniramine Maleate 1% Nasal SprayChlorpheniramine Malate (1%) Nasal Spray |
| Placebo Nasal Spray | Placebo comparator | Combination Product: PlaceboPlacebo Nasal Spray |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female patients between 18 and 65 years (both inclusive)
- Patients with positive RT-PCR test for SARS-CoV-2 in nasopharyngeal or oropharyngeal swabs (sample collected or proof of positive test ≤3 days before randomization)
- Patients with mild COVID-19 have the following symptoms and signs prior to randomization (≤ 3days)
- Upper respiratory tract symptoms (\&/or fever) without shortness of breath or hypoxia. (SpO2 > 94 %)
- Willingness to sign written informed consent document
Key exclusion criteria (16 listed)
- < 18 years of age
- Hospitalized patients
- Subject with known allergy or hypersensitivity to the components of the formulation.
- Patients receiving therapy with Monoamine oxidase inhibitors (MAOIs): rasagline, selegiline, isocarbonboxasid, phenelzine, tranylcypromine.
- Patients with narrow-angle glaucoma
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 |
|---|---|---|
| Chlorpheniramine Maleate 1% Nasal SprayAlso: ClorNasal, ClorNovirChlorpheniramine Maleate 1% Nasal Spray | Combination product | Chlorpheniramine Malate (1%) Nasal Spray |
| PlaceboPlacebo nasal spray | Combination product | Placebo Nasal Spray |
Primary outcome
Daily symptoms score (DSS)
Time frame: Baseline through day 7
Change from baseline daily symptoms score (DSS) to day 7 The DSS is an instrument comprised of a four-point severity rating scale ranging from 0 to 3. 0 = no symptoms 1. = mild symptoms 2. = moderate symptoms 3. = severe symptoms.
Visual Analog Scale (VAS)
Time frame: Baseline through day 7
Change from baseline visual analog scale (VAS) to day 7 The VAS is a quantitative method that evaluates the severity of symptoms on a scale of 1-10 (no signs to worst symptoms). A 10 cm line is used to grade the severity of symptoms from "no symptoms" (0 cm) to "the highest level of symptoms" (10 cm).
4 secondary outcomes
Hospitalization
Time frame: Baseline through Day 28
Mortality
Time frame: Baseline through Day 28
The proportion of subjects reporting olfactory function
Time frame: Baseline through Day 7
The proportion of subjects reporting the presence of upper respiratory symptoms
Time frame: Baseline through Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Individual participant dataSharing planned: Undecided
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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?
A Phase 2/3 study testing Chlorpheniramine Maleate 1% Nasal Spray in people with COVID-19 and Symptoms and Signs, run by Dr. Ferrer BioPharma at 1 site in Honduras.
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 5 inclusion and 16 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: finished, as of the sponsor's last update on 23 Mar 2023. 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 Honduras. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Daily symptoms score (DSS) (time frame: Baseline through day 7). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Mar 2023.