COVID-19Phase 2NCT05639166
Study in Adults to Assess the Safety and Efficacy of Inhaled IBIO123, for Post-exposure Prophylaxis of COVID-19
A Phase 2 study testing IBIO123 in people with COVID-19, run by Immune Biosolutions Inc at 5 sites in 2 countries.
Trial summary
This is a Phase 2, randomized, double-blind, multicentre, placebo-controlled study in adults to assess the safety and efficacy of inhaled IBIO123, for post-exposure prophylaxis of COVID-19. 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
- What is being tested?
- IBIO123
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 18 Feb 2023to 16 May 2023
- 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
- Are ≥18 years of age at the time of randomization
- Subject has a household contact with a confirmed COVID-19 cohabiting individual as subject. Initial diagnosis of the COVID-19 positive individual has been within 3 days of screening. COVID-19 positive result (PCR or Antigen) must have been performed by an accredited lab or medical professional. Current and uninterrupted household contacts were defined as family members or close relatives who had unprotected contact with the index case.
- Subject must have a negative result with the study provided rapid antigen test at baseline and be COVID-19 symptom free.
- Are men or non-pregnant women. Reproductive and Contraceptive agreements and guidance is provided in Appendix 2. Contraceptive use by men or women should be consistent with local regulations for those participating in clinical studies.
- Understand and agree to comply with planned study procedures
- Agree to the collection of nasopharyngeal swabs
- The participant or legally authorized representative gives signed informed consent as described in Section 10.1.1.2 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Who cannot join
- A positive COVID-19 result (PCR or antigen test) within 30 days of screening.
- Presence of typical COVID-19 symptoms which cannot be explained by another underlying condition (fever >38°C, Oxygen saturation (SpO2) below 93%, dyspnea, difficulty breathing, chills, ageusia, anosmia, cough, myalgia) in the past 48 hours prior to screening.
- Hypersensitivity to any component of IBIO123
- Participants who have been previously administered IBIO123.
- Have received treatment with a SARS-CoV-2 specific monoclonal antibody
- Have participated, within the last 30 days, in a clinical study involving an investigational intervention. If the previous investigational intervention has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed.
- Are pregnant or breast feeding
- Are investigator site personnel directly affiliated with this study.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Ukraine4 sites
Central City Clinical Hospital of Chernivtsi City Council
Chernivtsi, Chernivetska, 58005
City Clinical Hospital #1 of Ivano-Frankivsk City Council
Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018
Central C.H. of Ivano-Frankivsk
Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76025
Volyn Regional Clinical Hospital
Lutsk, Volyn Oblast, 43005
About this study
Official title: A Phase 2, Randomized, Double-blind, Multicentre, Placebo-controlled Study in Adults to Assess the Safety and Efficacy of Inhaled IBIO123, for Post-exposure Prophylaxis of COVID-19
This is a Phase 2, randomized, double-blind, multicentre, placebo-controlled study in adults to assess the safety and efficacy of inhaled IBIO123, for post-exposure prophylaxis of COVID-19.
This study aims to evaluate the efficacy and the safety of IBIO123 and the prophylaxis effect of IBIO123 in participants exposed to COVID-19 in the setting of current and uninterrupted household contacts.
Read the detailed description
This is a randomized, double-blind, multicentre, placebo-controlled study eligible patients will be randomized in a 1:1 ratio to receive either 10mg of IBIO123 or matching vehicle (placebo). IBIO123 will be administered by inhalation via an Aerogen Ultra mesh nebulizer according to the manufacturer's recommendation. Patients will be followed up for a total period of 14 days after the administration of study intervention to detect an infection to SARS-CoV-2.
This study will enroll a total of 140 participants (70 participants on IBIO123 \& 70 participants on Placebo).
- Conditions
- COVID-19
- Being tested
- IBIO123, Placebo
- Keywords
- IBIO, IBIO123, Prophylaxis, Inhalation, monoclonal antibodies, Prevention
- Medical subject headings
- COVID-19, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBIO123Biological
IBIO123 10 mg
PlaceboOther
Matching Placebo
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | IBIO123 10 mg Receives: Biological: IBIO123 |
| Placebo | Placebo comparator | Matching Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize the effect of IBIO123 compared to placebo on laboratory-confirmed COVID-19 infections between baseline and Day 14
- Proportion of participants who had a laboratory-confirmed COVID-19 infection between baseline and Day 14
Measured: From Baseline to Day 14
Secondary outcomes (6)
Characterize the effect of IBIO123 compared to placebo on laboratory-confirmed COVID-19 infections between baseline and Day 7
Proportion of participants who had a laboratory-confirmed COVID-19 infection between baseline and Day 7
Measured: From Baseline to Day 7
Characterize the effect of IBIO123 compared to placebo on laboratory-confirmed COVID-19 asymptomatic infections between baseline and Day 7
Proportion of participants who had a laboratory-confirmed asymptomatic COVID-19 infection between baseline and Day 7
Measured: From Baseline to Day 7
Characterize the effect of IBIO123 compared to placebo on laboratory-confirmed COVID-19 asymptomatic infections between baseline and Day 14
Proportion of participants who had a laboratory-confirmed asymptomatic COVID-19 infection between baseline and Day 14
Measured: From Baseline to Day 14
Characterize the effect of IBIO123 compared to placebo on overall participant clinical status
Proportion (percentage) of participants who experience these events by Day 14
- Hospitalisation
- Mortality
Measured: From Baseline to Day 14
Characterize the effect of IBIO123 compared to placebo on SARS-CoV-2 related symptoms
- Time to symptom onset
- Proportion of participants demonstrating symptom resolution on Days 7 \& 14.
- Proportion of participants demonstrating Mild, Moderate and Severe symptoms between baseline to Day 7 and day 14
Measured: From Baseline to Day 14
Characterize the effect of IBIO123 compared to placebo on safety and tolerability
Safety assessments such as adverse events (AEs) and Serious adverse events (SAEs)
Measured: From Baseline to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start18 Feb 2023
- Primary completion16 May 2023
- Study completion16 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Immune Biosolutions Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sebastien Labbe, PhD, Study director, Immune Biosolutions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05639166
- Sponsor's protocol ID
- IBIO-INH-003
- Status last verified
- May 2023
- First submitted
- 3 Dec 2022
- Last updated
- 22 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-blind, Multicentre, Placebo-controlled Study in Adults to Assess the Safety and Efficacy of Inhaled IBIO123, for Post-exposure Prophylaxis of COVID-19
- ClinicalTrials.gov ID
- NCT05639166
- Acronym / sponsor ID
- IBIO-INH-003
- Conditions
- COVID-19
- Keywords
- IBIO, IBIO123, Prophylaxis, Inhalation, monoclonal antibodies, Prevention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Immune Biosolutions IncIndustry (pharma, biotech, devices)
- Study start
- 18 Feb 2023 (actual)
- Primary completion
- 16 May 2023 (actual)
- Study completion
- 16 May 2023 (actual)
- First posted
- 6 Dec 2022 (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, multicentre, placebo-controlled study in adults to assess the safety and efficacy of inhaled IBIO123, for post-exposure prophylaxis of COVID-19.
This study aims to evaluate the efficacy and the safety of IBIO123 and the prophylaxis effect of IBIO123 in participants exposed to COVID-19 in the setting of current and uninterrupted household contacts.
Detailed description
This is a randomized, double-blind, multicentre, placebo-controlled study eligible patients will be randomized in a 1:1 ratio to receive either 10mg of IBIO123 or matching vehicle (placebo). IBIO123 will be administered by inhalation via an Aerogen Ultra mesh nebulizer according to the manufacturer's recommendation. Patients will be followed up for a total period of 14 days after the administration of study intervention to detect an infection to SARS-CoV-2.
This study will enroll a total of 140 participants (70 participants on IBIO123 \& 70 participants on Placebo).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Biological: IBIO123IBIO123 10 mg |
| Placebo | Placebo comparator | Other: PlaceboMatching Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Are ≥18 years of age at the time of randomization
- Subject has a household contact with a confirmed COVID-19 cohabiting individual as subject. Initial diagnosis of the COVID-19 positive individual has been within 3 days of screening. COVID-19 positive result (PCR or Antigen) must have been performed by an accredited lab or medical professional. Current and uninterrupted household contacts were defined as family members or close relatives who had unprotected contact with the index case.
- Subject must have a negative result with the study provided rapid antigen test at baseline and be COVID-19 symptom free.
- Are men or non-pregnant women. Reproductive and Contraceptive agreements and guidance is provided in Appendix 2. Contraceptive use by men or women should be consistent with local regulations for those participating in clinical studies.
- Understand and agree to comply with planned study procedures
Key exclusion criteria (8 listed)
- A positive COVID-19 result (PCR or antigen test) within 30 days of screening.
- Presence of typical COVID-19 symptoms which cannot be explained by another underlying condition (fever >38°C, Oxygen saturation (SpO2) below 93%, dyspnea, difficulty breathing, chills, ageusia, anosmia, cough, myalgia) in the past 48 hours prior to screening.
- Hypersensitivity to any component of IBIO123
- Participants who have been previously administered IBIO123.
- Have received treatment with a SARS-CoV-2 specific monoclonal antibody
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 |
|---|---|---|
| IBIO123IBIO123 10 mg | Biological | Active |
| PlaceboMatching Placebo | Other | Placebo |
Primary outcome
Characterize the effect of IBIO123 compared to placebo on laboratory-confirmed COVID-19 infections between baseline and Day 14
Time frame: From Baseline to Day 14
• Proportion of participants who had a laboratory-confirmed COVID-19 infection between baseline and Day 14
6 secondary outcomes
Characterize the effect of IBIO123 compared to placebo on laboratory-confirmed COVID-19 infections between baseline and Day 7
Time frame: From Baseline to Day 7
Characterize the effect of IBIO123 compared to placebo on laboratory-confirmed COVID-19 asymptomatic infections between baseline and Day 7
Time frame: From Baseline to Day 7
Characterize the effect of IBIO123 compared to placebo on laboratory-confirmed COVID-19 asymptomatic infections between baseline and Day 14
Time frame: From Baseline to Day 14
Characterize the effect of IBIO123 compared to placebo on overall participant clinical status
Time frame: From Baseline to Day 14
Characterize the effect of IBIO123 compared to placebo on SARS-CoV-2 related symptoms
Time frame: From Baseline to Day 14
Characterize the effect of IBIO123 compared to placebo on safety and tolerability
Time frame: From Baseline to Day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2023.
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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.
Sebastien Labbe, PhD study director
Immune Biosolutions
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IBIO123 in people with COVID-19, run by Immune Biosolutions Inc at 5 sites in 2 countries.
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 7 inclusion and 8 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: finished, as of the sponsor's last update on 22 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Ukraine, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Characterize the effect of IBIO123 compared to placebo on laboratory-confirmed COVID-19 infections between baseline and Day 14 (time frame: From Baseline to Day 14). 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 22 May 2023.