Back to resultsA Study to Evaluate Change in Viral Load After OPN-019 in Adults With COVID-19
Primary Purpose
Covid19
Status
Terminated
Phase
Phase 1
Locations
Mexico
Study Type
Interventional
Intervention
OPN-019
Sponsored by
About this trial
This is an interventional treatment trial for Covid19
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Fundacion Santos y de la Garza Evia, I.B.P
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
400 mg OPN-019
Standard of Care (SOC)
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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
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
Maximum log reduction in viral load
Compare maximum log reduction in viral load (copies/ml) by qRT-PCR
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
Log viral reduction assessment in subgroups-baseline viral load
Assess log viral reduction in subgroups by baseline viral load (copies/mL)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05035576
Brief Title
A Study to Evaluate Change in Viral Load After OPN-019 in Adults With COVID-19
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Terminated
Why Stopped
Sponsor Decision
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
November 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Optinose US Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
400 mg OPN-019
Arm Type
Active Comparator
Arm Title
Standard of Care (SOC)
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
OPN-019
Intervention Description
400 mg OPN-019, 2 sprays per nostril (one dose)
Primary Outcome Measure Information:
Title
Change in nasal viral load over multiple time points
Description
Change in nasal viral load (copies/mL) over multiple time points as measured by qRT-PCR testing of nasal swabs.
Time Frame
Baseline, 1 Hour, 3 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours post dosing/randomization
Secondary Outcome Measure Information:
Title
Cumulative viral load over 6, 8, and 12-hour periods in oropharyngeal swab
Description
Compare cumulative viral load (copies/mL) (total) over 6, 8, and 12-hour periods in oropharyngeal swab measured by qRT-PCR
Time Frame
6 Hours, 8 Hours, 12 Hours post Dosing/Randomization
Title
Cumulative amount of Nasal Swab infectious viral particles
Description
Compare cumulative amount of infectious viral particles (copies/mL) between OPN-019 dosed subjects versus SOC control group in nasal swab
Time Frame
Baseline, 24 Hours post dosing/randomization
Title
Number of subjects with viral load of <10^6 copies/mL
Description
Compare the number of subjects who reach a viral load (copies/ml) of <10^6
Time Frame
Baseline, 24 Hours post dosing/randomization
Title
Maximum log reduction in viral load
Description
Compare maximum log reduction in viral load (copies/ml) by qRT-PCR
Time Frame
Baseline, 24 Hours post dosing/randomization
Title
Time Comparison-subject virus-free or has viral load of <10^6 copies/ml
Description
Time over which subject is virus-free or has viral load (copies/mL) of <10^6 , both as measured by qRT-PCR
Time Frame
Baseline, 24 Hours post dosing/randomization
Title
Log viral reduction assessment in subgroups-baseline viral load
Description
Assess log viral reduction in subgroups by baseline viral load (copies/mL)
Time Frame
Baseline, 24 Hours post dosing/randomization
Other Pre-specified Outcome Measures:
Title
Evaluation of Safety by recording the severity of spontaneously reported adverse events (AEs)
Description
Assessment of safety by measuring severity of spontaneously reported AEs using scale with 1=mild, 2=moderate, 3=severe
Time Frame
Baseline, 24 Hours post dosing/randomization
Title
Evaluation of Safety measuring vital signs- Blood Pressure
Description
Includes systolic and diastolic blood pressure measurements in millimeter of mercury (mmHg)
Time Frame
Baseline, 24 Hours post dosing/randomization
Title
Evaluation of Safety measuring vital signs- Pulse
Description
Measure pulse in beats per minute (bpm)
Time Frame
Baseline, 24 Hours post dosing/randomization
Title
Evaluation of Safety measuring vital signs- Temperature
Description
Measure temperature in °Fahrenheit (°F)
Time Frame
Baseline, 24 Hours post dosing/randomization
Title
Evaluation of Safety measuring vital signs- Respiratory Rate
Description
Measure Respiratory Rate in breaths per minute
Time Frame
Baseline, 24 Hours post dosing/randomization
Title
Evaluation of Safety - Monitoring Concomitant Medication Usage
Description
Assessment for safety from the collection of information for concomitant medications usage
Time Frame
Baseline, 24 Hours post dosing/randomization
Title
Evaluation of Safety - Study Drug Tolerability
Description
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"
Time Frame
1 Hour Post Dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Carothers
Organizational Affiliation
OptiNose US
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
John Messina
Organizational Affiliation
OptiNose US
Official's Role
Study Chair
Facility Information:
Facility Name
Fundacion Santos y de la Garza Evia, I.B.P
City
Monterrey
State/Province
N.l.
ZIP/Postal Code
64710
Country
Mexico
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate Change in Viral Load After OPN-019 in Adults With COVID-19
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