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

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: Terminated
• Conditions: Covid19
• Intervention / Treatment: Drug: OPN-019

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: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 1 Hour, 3 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours post dosing/randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	Baseline, 24 Hours post dosing/randomization
Maximum log reduction in viral load	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 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	Assess log viral reduction in subgroups by baseline viral load (copies/mL)	Baseline, 24 Hours post dosing/randomization

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of Safety by recording the severity of spontaneously reported adverse events (AEs)	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	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	Measure pulse in beats per minute (bpm)	Baseline, 24 Hours post dosing/randomization
Evaluation of Safety measuring vital signs- Temperature	Measure temperature in °Fahrenheit (°F)	Baseline, 24 Hours post dosing/randomization
Evaluation of Safety measuring vital signs- Respiratory Rate	Measure Respiratory Rate in breaths per minute	Baseline, 24 Hours post dosing/randomization
Evaluation of Safety - Monitoring Concomitant Medication Usage	Assessment for safety from the collection of information for concomitant medications usage	Baseline, 24 Hours post dosing/randomization
Evaluation of Safety - Study Drug Tolerability	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

• Sponsor: Optinose US Inc.
• Investigators: Study Director: Jennifer Carothers, OptiNose US; Study Chair: John Messina, OptiNose US

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2021
• Primary Completion (ACTUAL): November 30, 2021
• Study Completion (ACTUAL): November 30, 2021

Study Registration Dates

• First Submitted: August 24, 2021
• First Submitted That Met QC Criteria: September 3, 2021
• First Posted (ACTUAL): September 5, 2021

Study Record Updates

• Last Update Posted (ACTUAL): May 2, 2022
• Last Update Submitted That Met QC Criteria: April 26, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID 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