Covid19Phase 1NCT05035576
A Study to Evaluate Change in Viral Load After OPN-019 in Adults With COVID-19
A Phase 1 study testing OPN-019 in people with Covid19, run by Optinose US Inc. at 1 site in Mexico.
Trial summary
The purpose of this study is to determine both the magnitude and duration of viral load (copies/mL) reduction after a single dose of OPN-019. The variability associated with viral counts will be utilized to inform the study design of future studies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- OPN-019
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteMexico
- Study dates
- 1 Sep 2021to 30 Nov 2021
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- men or women aged 18 years and older at Visit 1 (Baseline/Screening)
- women of child-bearing potential must have a negative urine pregnancy test at Visit 1 (Baseline/Screening)
- must be confirmed positive for SARS-CoV-2 with RT-PCR testing of a nasal swab taken within 72 hours prior to randomization (first dose of study drug)
- must have a score ≤ 2 on the WHO ordinal scale for clinical improvement
- subject must be willing to refrain from any other intranasal instillations (e.g., medications, saline, etc.) for 24 hours after study medication dosing
- must be capable, in the opinion of the investigator, of providing informed consent to participate in the study.
Who cannot join
- women who are pregnant or lactating
- hospitalized subjects or subjects requiring nursing care for COVID-19
- currently has one of the clinical signs suggestive of moderate-to-severe COVID-19 illness:
- O2 saturation of ≤ 93% on room air at sea level
- Heart rate ≥ 90 beats per minute (after seated for 5 min)
- Respiratory rate ≥ 20 breaths per minute
Show all 13Show fewer
- receiving respiratory support (including any form of oxygen therapy)
- history of hypothyroidism, goiter, hyperthyroidism, thyroid tumor, autoimmune thyroid disease
- currently taking medications that contain iodine or currently taking lithium
- receiving any other investigational drug
- has an allergy, hypersensitivity, or contraindication to povidone iodine
- has an allergy or hypersensitivity to any excipients in study medication
- any serious or unstable concurrent disease, psychiatric disorder, or any significant condition that, in the opinion of the investigator could confound the results of the study or could interfere with the subject's participation or compliance in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Adaptive Design, Proof of Concept, Single Dose Study to Evaluate Change in Viral Load After OPN-019 in Adults With COVID-19
The purpose of this study is to determine both the magnitude and duration of viral load (copies/mL) reduction after a single dose of OPN-019. The variability associated with viral counts will be utilized to inform the study design of future studies.
Read the detailed description
A randomized, single dose, adaptive design, proof of concept study in subjects who have tested positive for SARS-CoV-2 infection, are recently infected, and who have mild or no symptoms. Patients will be required to have a score ≤ 2 on the WHO ordinal scale for clinical improvement (Covid-19 Therapeutic Trial Synopsis; Feb 18, 2020). Those meeting the inclusion criteria will be randomized to 1 of 2 arms: OPN-019 (2 sprays per nostril) or SOC. Once randomized, subjects will have baseline nasal and oropharyngeal swabs performed for qRT-PCR viral load and infectious viral particle assessment. The subject will then be administered the study medication. Subsequent nasal and oropharyngeal swabs will be taken at 1 hour, 3 hours, 6 hours, 8 hours, 12 hours, and 24 hours. Cohorts of 10 subjects will be randomized into the study and the results from those subjects will be evaluated to determine if changes in the inclusion criteria or study assessments are required.
- Conditions
- Covid19
- Being tested
- OPN-019
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPN-019Drug
400 mg OPN-019, 2 sprays per nostril (one dose)
| Study group | Role | What they receive |
|---|---|---|
| 400 mg OPN-019 | Active comparator | Not described Receives: Drug: OPN-019 |
| Standard of Care (SOC) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in nasal viral load over multiple time points
Change in nasal viral load (copies/mL) over multiple time points as measured by qRT-PCR testing of nasal swabs.
Measured: Baseline, 1 Hour, 3 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours post dosing/randomization
Secondary outcomes (6)
Cumulative viral load over 6, 8, and 12-hour periods in oropharyngeal swab
Compare cumulative viral load (copies/mL) (total) over 6, 8, and 12-hour periods in oropharyngeal swab measured by qRT-PCR
Measured: 6 Hours, 8 Hours, 12 Hours post Dosing/Randomization
Cumulative amount of Nasal Swab infectious viral particles
Compare cumulative amount of infectious viral particles (copies/mL) between OPN-019 dosed subjects versus SOC control group in nasal swab
Measured: Baseline, 24 Hours post dosing/randomization
Number of subjects with viral load of <10^6 copies/mL
Compare the number of subjects who reach a viral load (copies/ml) of <10^6
Measured: Baseline, 24 Hours post dosing/randomization
Maximum log reduction in viral load
Compare maximum log reduction in viral load (copies/ml) by qRT-PCR
Measured: Baseline, 24 Hours post dosing/randomization
Time Comparison-subject virus-free or has viral load of <10^6 copies/ml
Time over which subject is virus-free or has viral load (copies/mL) of <10^6 , both as measured by qRT-PCR
Measured: Baseline, 24 Hours post dosing/randomization
Log viral reduction assessment in subgroups-baseline viral load
Assess log viral reduction in subgroups by baseline viral load (copies/mL)
Measured: Baseline, 24 Hours post dosing/randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start1 Sep 2021
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Why it stopped: Sponsor Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Optinose US Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jennifer Carothers, Study director, OptiNose USJohn Messina, Study chair, OptiNose US
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05035576
- Sponsor's protocol ID
- OPN-PVI-COV-1401
- Status last verified
- Apr 2022
- First submitted
- 24 Aug 2021
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Adaptive Design, Proof of Concept, Single Dose Study to Evaluate Change in Viral Load After OPN-019 in Adults With COVID-19
- ClinicalTrials.gov ID
- NCT05035576
- Acronym / sponsor ID
- OPN-PVI-COV-1401
- Conditions
- Covid19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Decision
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Optinose US Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 5 Sep 2021 (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 study is to determine both the magnitude and duration of viral load (copies/mL) reduction after a single dose of OPN-019. The variability associated with viral counts will be utilized to inform the study design of future studies.
Detailed description
A randomized, single dose, adaptive design, proof of concept study in subjects who have tested positive for SARS-CoV-2 infection, are recently infected, and who have mild or no symptoms. Patients will be required to have a score ≤ 2 on the WHO ordinal scale for clinical improvement (Covid-19 Therapeutic Trial Synopsis; Feb 18, 2020). Those meeting the inclusion criteria will be randomized to 1 of 2 arms: OPN-019 (2 sprays per nostril) or SOC. Once randomized, subjects will have baseline nasal and oropharyngeal swabs performed for qRT-PCR viral load and infectious viral particle assessment. The subject will then be administered the study medication. Subsequent nasal and oropharyngeal swabs will be taken at 1 hour, 3 hours, 6 hours, 8 hours, 12 hours, and 24 hours. Cohorts of 10 subjects will be randomized into the study and the results from those subjects will be evaluated to determine if changes in the inclusion criteria or study assessments are required.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 400 mg OPN-019 | Active comparator | Drug: OPN-019 |
| Standard of Care (SOC) | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- men or women aged 18 years and older at Visit 1 (Baseline/Screening)
- women of child-bearing potential must have a negative urine pregnancy test at Visit 1 (Baseline/Screening)
- must be confirmed positive for SARS-CoV-2 with RT-PCR testing of a nasal swab taken within 72 hours prior to randomization (first dose of study drug)
- must have a score ≤ 2 on the WHO ordinal scale for clinical improvement
- subject must be willing to refrain from any other intranasal instillations (e.g., medications, saline, etc.) for 24 hours after study medication dosing
Key exclusion criteria (13 listed)
- women who are pregnant or lactating
- hospitalized subjects or subjects requiring nursing care for COVID-19
- currently has one of the clinical signs suggestive of moderate-to-severe COVID-19 illness:
- receiving respiratory support (including any form of oxygen therapy)
- history of hypothyroidism, goiter, hyperthyroidism, thyroid tumor, autoimmune thyroid disease
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 |
|---|---|---|
| OPN-019400 mg OPN-019, 2 sprays per nostril (one dose) | Drug | 400 mg OPN-019 |
Primary outcome
Change in nasal viral load over multiple time points
Time frame: Baseline, 1 Hour, 3 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours post dosing/randomization
Change in nasal viral load (copies/mL) over multiple time points as measured by qRT-PCR testing of nasal swabs.
6 secondary outcomes
Cumulative viral load over 6, 8, and 12-hour periods in oropharyngeal swab
Time frame: 6 Hours, 8 Hours, 12 Hours post Dosing/Randomization
Cumulative amount of Nasal Swab infectious viral particles
Time frame: Baseline, 24 Hours post dosing/randomization
Number of subjects with viral load of <10^6 copies/mL
Time frame: Baseline, 24 Hours post dosing/randomization
Maximum log reduction in viral load
Time frame: Baseline, 24 Hours post dosing/randomization
Time Comparison-subject virus-free or has viral load of <10^6 copies/ml
Time frame: Baseline, 24 Hours post dosing/randomization
Log viral reduction assessment in subgroups-baseline viral load
Time frame: Baseline, 24 Hours post dosing/randomization
Results and safety
The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
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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.
Jennifer Carothers study director
OptiNose US
John Messina study chair
OptiNose US
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OPN-019 in people with Covid19, run by Optinose US Inc. at 1 site in Mexico.
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 6 inclusion and 13 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: stopped early, as of the sponsor's last update on 2 May 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 Mexico. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early (reason given: Sponsor Decision). 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?
Change in nasal viral load over multiple time points (time frame: Baseline, 1 Hour, 3 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours post dosing/randomization). 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 2 May 2022.