COVID-19 PandemicPhase 2NCT05118763
Intranasal INNA-051 for Prevention of COVID-19 in Adults
A Phase 2 study testing INNA-051 in people with COVID-19 Pandemic, run by ENA Respiratory Pty Ltd.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Pandemic
- What is being tested?
- INNA-051
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2022to 31 Dec 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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
About this study
Official title: 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
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.
Read the detailed description
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).
- Conditions
- COVID-19 Pandemic
- Being tested
- INNA-051, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INNA-051Drug
Liquid for intranasal administration
PlaceboOther
Liquid for intranasal administration
| Study group | Role | What they receive |
|---|---|---|
| INNA-051 arm 1 | Experimental | INNA-051 intranasal spray low dose administered once on each of Days 1, 4, 7 and 10 Receives: 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 Receives: Drug: INNA-051 |
| Placebo | Placebo comparator | Placebo intranasal spray high dose administered once on each of Days 1, 4, 7 and 10 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: To Day 14
Evaluate the safety and tolerability of INNA 051.
Treatment emergent adverse events
Measured: 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
Incidences of RT PCR confirmed moderate or severe SARS-CoV-2 infection, or COVID 19 related death
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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 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
Measured: To Day 14 and to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2021
- Study start1 Mar 2022 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PandemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised double blind placebo controlled parallel arm
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- ENA Respiratory Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05118763
- Sponsor's protocol ID
- INNA-051-COVID-PEP-01
- Status last verified
- Apr 2022
- First submitted
- 27 Oct 2021
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No plan
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05118763
- Acronym / sponsor ID
- INNA-051-COVID-PEP-01
- Conditions
- COVID-19 Pandemic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ENA Respiratory Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2022 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 12 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomised double blind placebo controlled parallel arm
| Arm | Type | Receives |
|---|---|---|
| INNA-051 arm 1 | Experimental | Drug: INNA-051INNA-051 intranasal spray low dose administered once on each of Days 1, 4, 7 and 10 |
| INNA-051 arm 2 | Experimental | Drug: INNA-051INNA-051 intranasal spray high dose administered once on each of Days 1, 4, 7 and 10 |
| Placebo | Placebo comparator | Other: PlaceboPlacebo intranasal spray high dose administered once on each of Days 1, 4, 7 and 10 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INNA-051Liquid for intranasal administration | Drug | INNA-051 arm 1, INNA-051 arm 2 |
| PlaceboLiquid for intranasal administration | Other | Placebo |
Primary outcome
Evaluate the ability of INNA-051 to reduce the incidence of symptomatic RT-PCR confirmed SARS-CoV-2 infection
Time frame: To Day 14
Incidence of symptomatic RT PCR confirmed SARS CoV 2 infection
Evaluate the safety and tolerability of INNA 051.
Time frame: To Day 42
Treatment emergent adverse events
8 secondary outcomes
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: On Day 14 and Day 28
Evaluate the ability of INNA 051 to reduce the incidence of RT PCR confirmed SARS CoV-2 infection
Time frame: To Day 28
Evaluate the ability of INNA 051 to reduce the incidence of RT PCR confirmed SARS CoV-2 infection
Time frame: To Day 14 and to Day 28
Evaluate the ability of INNA 051 to reduce COVID 19 related healthcare utilization
Time frame: To Day 14 and to Day 28
Evaluate the ability of INNA 051 to reduce COVID 19 related healthcare utilization
Time frame: To Day 14 and to Day 28
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
- Individual participant dataSharing planned: No. No plan
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing INNA-051 in people with COVID-19 Pandemic, run by ENA Respiratory Pty Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the ability of INNA-051 to reduce the incidence of symptomatic RT-PCR confirmed SARS-CoV-2 infection (time frame: To Day 14). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2022.