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

Phase 1

Terminated

• Conditions: Covid19
• Interventions: Drug: OPN-019

• Registration Number: NCT05035576
• Lead Sponsor: Optinose US Inc.

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.

Study Timeline

• Study First Submitted: 2021-08-24
• Study Start: 2021-09-01
• Study First Submitted QC: 2021-09-03
• Study First Posted: 2021-09-05
• Primary Completion: 2021-11-30
• Study Completion: 2021-11-30
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-26
• Last Update Posted: 2022-05-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
400 mg OPN-019	OPN-019	-

Primary Outcome Measures

Name	Time	Method
Change in nasal viral load over multiple time points	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.

Secondary Outcome Measures

Name	Time	Method
Cumulative viral load over 6, 8, and 12-hour periods in oropharyngeal swab	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
Cumulative amount of Nasal Swab infectious viral particles	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
Number of subjects with viral load of <10^6 copies/mL	Baseline, 24 Hours post dosing/randomization	Compare the number of subjects who reach a viral load (copies/ml) of \<10\^6
Maximum log reduction in viral load	Baseline, 24 Hours post dosing/randomization	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	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
Log viral reduction assessment in subgroups-baseline viral load	Baseline, 24 Hours post dosing/randomization	Assess log viral reduction in subgroups by baseline viral load (copies/mL)

Trial Locations

Locations (1)

Fundacion Santos y de la Garza Evia, I.B.P; 🇲🇽 Monterrey, N.l., Mexico