Clinical trial NCT05035576: 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
Overall status: TERMINATED
Phase: PHASE1
Conditions: Covid19
Lead sponsor: Optinose US Inc.
Sponsor class: INDUSTRY
First posted: 2021-09-05
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in nasal viral load over multiple time points
timeFrame: Baseline, 1 Hour, 3 Hours, 6 Hours, 8 Hours, 12 Hours, 24 Hours post dosing/randomization
Secondary outcomes:
measure: Cumulative viral load over 6, 8, and 12-hour periods in oropharyngeal swab
timeFrame: 6 Hours, 8 Hours, 12 Hours post Dosing/Randomization
measure: Cumulative amount of Nasal Swab infectious viral particles
timeFrame: Baseline, 24 Hours post dosing/randomization
measure: Number of subjects with viral load of <10^6 copies/mL
timeFrame: Baseline, 24 Hours post dosing/randomization
measure: Maximum log reduction in viral load
timeFrame: Baseline, 24 Hours post dosing/randomization
measure: Time Comparison-subject virus-free or has viral load of <10^6 copies/ml
timeFrame: Baseline, 24 Hours post dosing/randomization
measure: Log viral reduction assessment in subgroups-baseline viral load
timeFrame: Baseline, 24 Hours post dosing/randomization
Other outcomes:
measure: Evaluation of Safety by recording the severity of spontaneously reported adverse events (AEs)
timeFrame: Baseline, 24 Hours post dosing/randomization
measure: Evaluation of Safety measuring vital signs- Blood Pressure
timeFrame: Baseline, 24 Hours post dosing/randomization
measure: Evaluation of Safety measuring vital signs- Pulse
timeFrame: Baseline, 24 Hours post dosing/randomization
measure: Evaluation of Safety measuring vital signs- Temperature
timeFrame: Baseline, 24 Hours post dosing/randomization
measure: Evaluation of Safety measuring vital signs- Respiratory Rate
timeFrame: Baseline, 24 Hours post dosing/randomization
measure: Evaluation of Safety - Monitoring Concomitant Medication Usage
timeFrame: Baseline, 24 Hours post dosing/randomization
measure: Evaluation of Safety - Study Drug Tolerability
timeFrame: 1 Hour Post Dose
Locations:
city: Monterrey
country: Mexico
facility: Fundacion Santos y de la Garza Evia, I.B.P
state: N.l.
Study officials:
affiliation: OptiNose US
name: Jennifer Carothers
role: STUDY_DIRECTOR
affiliation: OptiNose US
name: John Messina
role: STUDY_CHAIR
References: