Intranasal INNA-051 for Prevention of COVID-19 in Adults

Study Overview
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Brief Summary
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This is a Phase 2, randomized, double-blind, placebo-controlled study of INNA-051 in adults following household contact with an individual with RT-PCR confirmed SARS CoV-2 infection. This study will evaluate 2 active dose levels of INNA-051 and placebo.

Detailed Description
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Adults who have a household member with RT-PCR-confirmed SARS-CoV-2 infection and have been in close contact, and who test negative to SARS-CoV-2, will be randomized. Participants will receive 4 doses of study medication over a 10 day period, and complete symptoms scores and questionnaires. Development of COVID-19 symptoms will require collection of a nasal swab for RT-PCR testing. Telephone visits will occur on Days 2, 4, 10, 21, 28, and 35. Additional visits will occur on Days 7, 14, and 42 (end of study).

Official Title
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A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety, Tolerability, and Efficacy of Intranasal INNA-051 for Prevention of COVID-19 in Adults Following Close Contact With Individuals With SARS-CoV-2 Infection

Conditions
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COVID-19 Pandemic

Intervention / Treatment
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* Drug: INNA-051
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Capable of understanding the written informed consent, provides signed written informed consent, and agrees to comply with protocol requirements. Male or female aged ≥18 years. Must have a symptomatic household contact (index case) with rapid antigen/point of-care or RT-PCR-confirmed SARS-CoV-2 infection and onset of symptoms in the household contact within 5 days prior to screening. Participants of non-childbearing potential. Non-childbearing potential is defined as surgically sterile (history of bilateral tubal ligation, bilateral oophorectomy, hysterectomy, or vasectomy) or postmenopausal (amenorrhea for at least 12 months prior to screening without an alternative medical cause). Exclusion Criteria: Prior exposure to INNA-051. Previous receipt of any full primary series SARS-CoV-2 vaccine or receipt of a booster vaccination following a full primary series within 12 months of screening. Any symptoms of COVID-19 within 72 hours prior to screening. Symptoms may include fever (≥38°C), cough, sore throat, malaise, headache, muscle pain, nausea, vomiting, diarrhea, loss of taste and/or smell, shortness of breath, or difficulty breathing. History of RT-PCR-confirmed SARS-CoV-2 infection within 6 months prior to screening. Positive point-of-care rapid SARS-CoV-2 diagnostic test at the time of screening. Body mass index ≥35 kg/m2. History of human immunodeficiency virus, current chronic hepatitis B virus or hepatitis C virus infection or current tuberculosis. History of chronic kidney disease (Stage 3 or higher). Chronic lung disease (chronic obstructive pulmonary disease, moderate-to-severe poorly controlled asthma [as evident within the last month of awakening with asthma symptoms 1 or more times/week or use of short-acting beta-agonists 3 or more times/week], interstitial lung disease, cystic fibrosis, pulmonary hypertension). History of significant cardiovascular disease (e.g., congestive heart failure, cardiomyopathy, ischemic heart disease) or history of myocarditis or pericarditis. Current uncontrolled hypertension defined as average of 3 systolic blood pressure readings of ≥140 mmHg or an average of 3 diastolic blood pressure ≥90 mmHg. History of chronic liver disease or documented evidence of liver fibrosis or cirrhosis. History of hemoglobinopathy (sickle cell disease, thalassemia). Chronic use of inhaled substances including tobacco, nicotine vapor, or cannabis (average of ≥5 cigarettes a day for ≥1 month within 1 year of screening or a 10 pack year history or equivalent). History of neurological or neurodevelopmental conditions (e.g., Down's syndrome, dementia, migraine, epilepsy, stroke, seizure in the last 3 years, encephalopathy, focal neurologic deficits, Guillain-Barré syndrome, encephalomyelitis, or transverse myelitis). History of malignancy in the last 5 years, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. History of immunodeficiency or chronic use (more than 14 continuous days) of any medication that may be associated with changes in the immune function including, but not limited to, systemic corticosteroids exceeding 10 mg/day of prednisone equivalent, allergy injections, immunoglobulin, interferon, immunomodulators, cytotoxic drugs, or other similar or toxic drugs within 6 months of screening. Note: The use of low-dose topical and ophthalmic steroid preparations is permitted. Use of nasal sprays (including but not limited to nasal glucocorticoids), intranasal washes, or other intranasal applications within 7 days prior to screening, or planned use during the study period. Known allergy or sensitivity or contraindication to study drug or its excipients. Treatment with any other investigational therapy or device within 30 days or within 5 half-lives, whichever is longer, prior to screening. Female participants who are pregnant or trying to become pregnant, or who are breastfeeding. Known history of substance abuse that in the investigator's judgment would prevent participant from providing informed consent or being able to comply with study procedures. Other severe, acute, or chronic medical or psychiatric condition(s) that may increase the risk associated with study participation or interfere with the participant's ability to comply with study procedures

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised double blind placebo controlled parallel arm
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: INNA-051 arm 1<br>INNA-051 intranasal spray low dose administered once on each of Days 1, 4, 7 and 10 | Drug: INNA-051<br>* Liquid for intranasal administration<br>|
| Experimental: INNA-051 arm 2<br>INNA-051 intranasal spray high dose administered once on each of Days 1, 4, 7 and 10 | Drug: INNA-051<br>* Liquid for intranasal administration<br>|
| Placebo Comparator: Placebo<br>Placebo intranasal spray high dose administered once on each of Days 1, 4, 7 and 10 | Other: Placebo<br>* Liquid for intranasal administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the ability of INNA-051 to reduce the incidence of symptomatic RT-PCR confirmed SARS-CoV-2 infection | Incidence of symptomatic RT PCR confirmed SARS CoV 2 infection | To Day 14 | 
| Evaluate the safety and tolerability of INNA 051. | Treatment emergent adverse events | To Day 42 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the ability of INNA 051 to reduce the severity of symptoms in adults who develop RT PCR confirmed SARS CoV-2 infection after randomization | Incidences of RT PCR confirmed moderate or severe SARS-CoV-2 infection, or COVID 19 related death | To Day 14 and to Day 28 | 
| Evaluate the ability of INNA 051 to reduce the severity of symptoms in adults who develop RT PCR confirmed SARS CoV-2 infection after randomization | Incidences of RT-PCR confirmed severe SARS-CoV-2 infection, or COVID-19-related death | To Day 14 and to Day 28 | 
| Evaluate the ability of INNA 051 to reduce the severity of symptoms in adults who develop RT PCR confirmed SARS CoV-2 infection after randomization | Modified FLU-PRO© total scores | On Day 14 and Day 28 | 
| Evaluate the ability of INNA 051 to reduce the severity of symptoms in adults who develop RT PCR confirmed SARS CoV-2 infection after randomization | Modified FLU-PRO subscale scores for symptom severity by body system (nose, throat, eyes, chest/respiratory and gastrointestinal) in participants with RT PCR confirmed SARS CoV-2 infection | On Day 14 and Day 28 | 
| Evaluate the ability of INNA 051 to reduce the incidence of RT PCR confirmed SARS CoV-2 infection | Incidence of symptomatic RT-PCR-confirmed SARS CoV-2 infection confirmed SARS CoV-2 infection | To Day 28 | 
| Evaluate the ability of INNA 051 to reduce the incidence of RT PCR confirmed SARS CoV-2 infection | Incidence of RT PCR confirmed SARS CoV-2 infection, through Day 14 and Day 28 | To Day 14 and to Day 28 | 
| Evaluate the ability of INNA 051 to reduce COVID 19 related healthcare utilization | Incidences of COVID 19 related emergency room visits, hospitalizations, or COVID 19 related death among participants with RT PCR confirmed SARS CoV-2 infection | To Day 14 and to Day 28 | 
| Evaluate the ability of INNA 051 to reduce COVID 19 related healthcare utilization | 2. Incidences of COVID 19 related medically attended visits (telemedicine, physician office, urgent care center, emergency room, hospitalization) or COVID 19 related death among participants with RT PCR-confirmed SARS CoV-2 infection | To Day 14 and to Day 28 |