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

NCT05035576 | Terminated Phase 1

• 1 other identifier: OPN-PVI-COV-1401
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Cumulative viral load over 6, 8, and 12-hour periods in oropharyngeal swab

  6 Hours, 8 Hours, 12 Hours post Dosing/Randomization

• Cumulative amount of Nasal Swab infectious viral particles

  Baseline, 24 Hours post dosing/randomization

• Number of subjects with viral load of <10^6 copies/mL

  Baseline, 24 Hours post dosing/randomization

• Maximum log reduction in viral load

  Baseline, 24 Hours post dosing/randomization

• Time Comparison-subject virus-free or has viral load of <10^6 copies/ml

  Baseline, 24 Hours post dosing/randomization

Other Outcomes (7)

• Evaluation of Safety by recording the severity of spontaneously reported adverse events (AEs)

  Baseline, 24 Hours post dosing/randomization

• Evaluation of Safety measuring vital signs- Blood Pressure

  Baseline, 24 Hours post dosing/randomization

• Evaluation of Safety measuring vital signs- Pulse

  Baseline, 24 Hours post dosing/randomization

Study Arms (2)

400 mg OPN-019

ACTIVE COMPARATOR

Drug: OPN-019

Standard of Care (SOC)

NO INTERVENTION

Interventions

OPN-019 DRUG

400 mg OPN-019, 2 sprays per nostril (one dose)

400 mg OPN-019

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Optinose US Inc.: lead

Study Sites (1)

Fundacion Santos y de la Garza Evia, I.B.P

Monterrey, N.L., 64710, Mexico

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jennifer Carothers

  OptiNose US

  STUDY DIRECTOR

• John Messina

  OptiNose US

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2021
• First Posted: September 5, 2021
• Study Start: September 1, 2021
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: May 2, 2022

Record last verified: 2022-04

Locations

ME (1)