A Study to Evaluate Change in Viral Load After OPN-019 in Adults With COVID-19

April 26, 2022 updated by: Optinose US Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

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

  • Mexico
    • N.l.
      • Monterrey, N.l., Mexico, 64710
        • Fundación Santos y de la Garza Evia, I.B.P

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. men or women aged 18 years and older at Visit 1 (Baseline/Screening)
  2. women of child-bearing potential must have a negative urine pregnancy test at Visit 1 (Baseline/Screening)
  3. 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)
  4. must have a score ≤ 2 on the WHO ordinal scale for clinical improvement
  5. subject must be willing to refrain from any other intranasal instillations (e.g., medications, saline, etc.) for 24 hours after study medication dosing
  6. must be capable, in the opinion of the investigator, of providing informed consent to participate in the study.

Exclusion Criteria:

  1. women who are pregnant or lactating
  2. hospitalized subjects or subjects requiring nursing care for COVID-19

  3. currently has one of the clinical signs suggestive of moderate-to-severe COVID-19 illness:

    1. O2 saturation of ≤ 93% on room air at sea level
    2. Heart rate ≥ 90 beats per minute (after seated for 5 min)
    3. Respiratory rate ≥ 20 breaths per minute
  4. receiving respiratory support (including any form of oxygen therapy)
  5. history of hypothyroidism, goiter, hyperthyroidism, thyroid tumor, autoimmune thyroid disease
  6. currently taking medications that contain iodine or currently taking lithium
  7. receiving any other investigational drug
  8. has an allergy, hypersensitivity, or contraindication to povidone iodine
  9. has an allergy or hypersensitivity to any excipients in study medication
  10. 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

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

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
NO_INTERVENTION: Standard of Care (SOC)
ACTIVE_COMPARATOR: 400 mg OPN-019
Drug: OPN-019
400 mg OPN-019, 2 sprays per nostril (one dose)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, 1 Hour, 3 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours post dosing/randomization

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cumulative viral load over 6, 8, and 12-hour periods in oropharyngeal swab
Time Frame: 6 Hours, 8 Hours, 12 Hours post Dosing/Randomization
Compare cumulative viral load (copies/mL) (total) over 6, 8, and 12-hour periods in oropharyngeal swab measured by qRT-PCR
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
Compare cumulative amount of infectious viral particles (copies/mL) between OPN-019 dosed subjects versus SOC control group in nasal swab
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
Compare the number of subjects who reach a viral load (copies/ml) of <10^6
Baseline, 24 Hours post dosing/randomization
Maximum log reduction in viral load
Time Frame: Baseline, 24 Hours post dosing/randomization
Compare maximum log reduction in viral load (copies/ml) by qRT-PCR
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
Time over which subject is virus-free or has viral load (copies/mL) of <10^6 , both as measured by qRT-PCR
Baseline, 24 Hours post dosing/randomization
Log viral reduction assessment in subgroups-baseline viral load
Time Frame: Baseline, 24 Hours post dosing/randomization
Assess log viral reduction in subgroups by baseline viral load (copies/mL)
Baseline, 24 Hours post dosing/randomization

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evaluation of Safety by recording the severity of spontaneously reported adverse events (AEs)
Time Frame: Baseline, 24 Hours post dosing/randomization
Assessment of safety by measuring severity of spontaneously reported AEs using scale with 1=mild, 2=moderate, 3=severe
Baseline, 24 Hours post dosing/randomization
Evaluation of Safety measuring vital signs- Blood Pressure
Time Frame: Baseline, 24 Hours post dosing/randomization
Includes systolic and diastolic blood pressure measurements in millimeter of mercury (mmHg)
Baseline, 24 Hours post dosing/randomization
Evaluation of Safety measuring vital signs- Pulse
Time Frame: Baseline, 24 Hours post dosing/randomization
Measure pulse in beats per minute (bpm)
Baseline, 24 Hours post dosing/randomization
Evaluation of Safety measuring vital signs- Temperature
Time Frame: Baseline, 24 Hours post dosing/randomization
Measure temperature in °Fahrenheit (°F)
Baseline, 24 Hours post dosing/randomization
Evaluation of Safety measuring vital signs- Respiratory Rate
Time Frame: Baseline, 24 Hours post dosing/randomization
Measure Respiratory Rate in breaths per minute
Baseline, 24 Hours post dosing/randomization
Evaluation of Safety - Monitoring Concomitant Medication Usage
Time Frame: Baseline, 24 Hours post dosing/randomization
Assessment for safety from the collection of information for concomitant medications usage
Baseline, 24 Hours post dosing/randomization
Evaluation of Safety - Study Drug Tolerability
Time Frame: 1 Hour Post Dose
Study Medication Tolerability Questionnaire will be completed by subjects rate the levels of nasal discomfort and unpleasant taste associated with study medication use; study specific measure. The Study Medication Tolerability Questionnaire is administered verbally by a study staff member to the subject. This 11-item score is rated on a 0-100 scale, 0 being "dislike it an extreme amount", and 100 being "like it an extreme amount"
1 Hour Post Dose

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Optinose US Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Jennifer Carothers, OptiNose US
  • Study Chair: John Messina, OptiNose US

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2021

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 24, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 5, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 2, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OPN-PVI-COV-1401

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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