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

Optinose

Status and phase: Terminated; Phase 1

Conditions: Covid19

Treatments: Drug: OPN-019

Study type: Interventional

Funder types: Industry

Identifiers

NCT05035576

OPN-PVI-COV-1401

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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8 participants in 2 patient groups

400 mg OPN-019

Active Comparator group

Treatment:

Drug: OPN-019

Standard of Care (SOC)

No Intervention group