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

NCT05118763 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: INNA-051-COVID-PEP-01
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

COVID-19 Pandemic

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• 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

  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

  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

  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

  On Day 14 and Day 28

• Evaluate the ability of INNA 051 to reduce the incidence of RT PCR confirmed SARS CoV-2 infection

  To Day 28

Study Arms (3)

INNA-051 arm 1

EXPERIMENTAL

INNA-051 intranasal spray low dose administered once on each of Days 1, 4, 7 and 10

Drug: INNA-051

INNA-051 arm 2

EXPERIMENTAL

INNA-051 intranasal spray high dose administered once on each of Days 1, 4, 7 and 10

Drug: INNA-051

Placebo

PLACEBO COMPARATOR

Placebo intranasal spray high dose administered once on each of Days 1, 4, 7 and 10

Other: Placebo

Interventions

INNA-051 DRUG

Liquid for intranasal administration

INNA-051 arm 1; INNA-051 arm 2

Placebo OTHER

Liquid for intranasal administration

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• ENA Respiratory Pty Ltd: lead

MeSH Terms

Conditions

COVID-19

Interventions

INNA-051

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 Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomised double blind placebo controlled parallel arm

Study Record Dates

• First Submitted: October 27, 2021
• First Posted: November 12, 2021
• Study Start: March 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: April 14, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share