AzTrials
AzTrials

COVID-19Phase 1/2NCT05303376

Phase 1&2 Study to Evaluate the Safety & Efficacy of Inhaled IBIO123 in Severe COVID-19 Illness

A Phase 1/2 study testing IBIO123 in people with COVID-19, run by Immune Biosolutions Inc at 5 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a Phase 1 and phase 2, adaptive, placebo-controlled, double-blind, randomized single-dose study in participants with Severe COVID-19 illness. Read more about this study

Who is it for?
Ages 18 years and older
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
123 participants
Where
5 sitesin 2 countries
Study dates
22 Feb 2022to 27 Jun 2023
Phase
Phase 1/2
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age
  • Are ≥18 years of age at the time of randomization
  • Disease Characteristics
  • Are currently hospitalized since less or equal than 3 days for COVID-19 respiratory illness
  • Must have a positive SARS-CoV-2 viral infection determination prior to randomisation. For the phase 2 portion of the study only, the test must be performed within 24 hours before randomisation. Test can be a PCR or an antigen test originated from the institution or any government approved testing site. If the original test result is greater than 24 hours from randomisation, a rapid antigen must be performed at bedside by the study team to determine eligibility
  • Sex
Show all 12Show fewer
  • 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.
  • Study Procedures
  • Understand and agree to comply with planned study procedures
  • Agree to the collection of nasopharyngeal swabs and venous blood
  • Informed Consent
  • The participant or legally authorized representative give signed informed consent

Who cannot join

  • Medical Conditions
  • COVID-19 onset of symptoms began more than 10 days before randomisation
  • Currently intubated or intubation is planned within the next 24 hours
  • Have known allergies to any of the components used in the formulation of the interventions
  • Suspected or proven serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking intervention
  • Have any co-morbidity requiring surgery within <7 days, or that is considered life- threatening within 29 days
Show all 13Show fewer
  • Have any serious concomitant systemic disease, condition, or disorder that, in the opinion of the investigator, should preclude participation in this study.
  • Other Exclusions
  • 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 concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
  • 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

Ukraine3 sites

  • Central City Clinical Hospital of Ivano-Frankivsk City Council

    Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76000

  • City Clinical Hospital #1 of Ivano-Frankivsk City Council

    Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018

  • Hospital №1" of the Zhytomyr City Council

    Zhytomyr, Zhytomyr Oblast, 10002

Other trials in Ukraine

South Africa2 sites

  • JOHESE UNITAS Hospital

    Lyttelton, Centurion, 0157

  • JOHESE ZAH Hospital

    Pretoria, Gauteng, 0002

Other trials in South Africa

About this study

Official title: A Randomized, Double-blind, Placebo-Controlled, Escalating Single Dose, Phase 1 & Phase 2 Study to Evaluate the Safety and Efficacy of Inhaled IBIO123 in Participants With Severe COVID-19 Illness

This is a Phase 1 and phase 2, adaptive, placebo-controlled, double-blind, randomized single-dose study in participants with Severe COVID-19 illness.

Read the detailed description

In Phase 1, in hospital in a continuous observation setting the first cohort will recruit a total of 8 participants who will receive a single inhaled administration of the study treatment. This cohort will consist of 6 participants on active treatment at a dose of 5mg (0.5cc) of IBIO123 and 2 participants on placebo (0.5cc). Participants will be followed for a total duration of 7 days which is greater than 5 expected half-lives of the study drug in lungs. Therefore, after 7 days, negligible amount of the study drug should remain in the lungs of participants. Safety data will be collected and reviewed by a Data Monitoring Committee (DMC). If no stopping rules have been met, the DMC will recommend the dosing of the second cohort at the expected therapeutic dose of 10mg. If stopping rules have been met the DMC will recommend the termination of the study.

The second cohort will be recruited in hospital in continuous observation setting and recruit a total of 8 participants who will receive a single inhaled administration of the study treatment. This cohort will consist of 6 participants on active treatment at a dose of 10mg of IBIO123 (1 cc) and 2 participants on placebo (1 cc).

Participants will be followed for a total duration of 7 days which is greater than 5 expected half-lives of the study drug in lungs. Therefore, after 7 days, negligible amount of the study drug should remain in the lungs of participants. Safety data will be collected and reviewed by a Data Monitoring Committee (DMC). If no stopping rules have been met the DMC will recommend the phase 2 dose of 10mg. If stopping rules have been met the DMC will recommend a phase 2 dose of 5 mg.

In Phase 2, in the lead-in portion of the phase 2, the DMC will meet 7 days after the first 9 subjects (3 Placebo and 6 Active) have completed their day 7 visit to review safety information of these subjects that have been dosed with 10mg of IBIO123 on Days 1 and 3. If this dose regimen is deemed safe by the DMC, the phase 2 study enrolment will pursue and be completed at 10mg on Day 1 and 10 mg on Day 3. If stopping rules were obtained during the Safety review, the study enrolment will be pursued with a single dose of 10mg of IBIO 123 on Day 1.

Conditions
COVID-19
Being tested
IBIO123, Placebo
Keywords
SARS-CoV-2, Monoclonal antibodies, Inhalation, IBIO, IBIO123, Severe, Hospitalized
Medical subject headings
COVID-19, Respiratory Aspiration, Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IBIO123Biological

    5 or 10 mg

  • PlaceboOther

    matching placebo

Study groups in NCT05303376
Study groupRoleWhat they receive
ActiveExperimentalNot described
Receives: Biological: IBIO123
PlaceboPlacebo comparatorNot described
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 1: Characterize the effect of IBIO123 compared to placebo on safety and tolerability

    • Safety assessments such as AEs and SAEs

    Measured: Baseline to Day 7

  2. Phase 2: Characterize the effect of IBIO123 compared to placebo on SARS-CoV-2 viral load and viral clearance

    • Change from baseline to Day 5 (± 2 days) in SARS-CoV-2 viral load

    Measured: Baseline to Day 5

Secondary outcomes (8)

  1. Phase 1: Characterize the effect of IBIO123 compared to placebo on SARS-CoV-2 viral load and viral clearance

    • Change from baseline to Day 7 (± 2 days) in SARS-CoV-2 viral load

    Measured: Baseline to Day 7

  2. Phase 2: Characterize the effect of IBIO123 compared to placebo on COVID-19 clinical progression

    • Change over time from baseline to Day 29 (± 2 days) in COVID-19 WHO Clinical Progression Scale

    Measured: Baseline to Day 29

  3. Phase 2: Characterize the effect of IBIO123 compared to placebo on overall participant clinical status

    • Proportion (percentage) of participants who experience these events by Day 29
    • ICU admission
    • intubation
    • Mortality
    • Discharge from Hospitalisation

    Measured: Baseline to Day 29

  4. Phase 2: Characterize the effect of IBIO123 compared to placebo on safety and tolerability

    • Safety assessments such as AEs and SAEs

    Measured: Baseline to Day 29

  5. Phase 2: Characterize the effect of IBIO123 compared to placebo on length of stay in hospital

    • Mean duration of hospitalisation and ICU care (days)

    Measured: Baseline to Day 29

  6. Phase 2: Characterize the effect of IBIO123 compared to placebo on oxygen supplementation and ventilation needs

    Mean duration of oxygen treatment (days) and Incidence of Intubation and Mean duration of Intubation (days)

    Measured: Baseline to Day 29

  7. Phase 2: Characterize the pharmacokinetics of IBIO123

    IBIO123 mean plasma concentration

    Measured: Days 1, 3, 7 and 29

  8. Phase 2: Characterize the immunogenicity of IBIO123

    Assessment of Anti-drug antibodies of IBIO123 at Day 1 and 29

    Measured: Baseline to Day 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2022
  2. Study start22 Feb 2022
  3. Primary completion27 Jun 2023
  4. Study completion27 Jun 2023

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
123 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05303376
Sponsor's protocol ID
IBIO-INH-002
Status last verified
Sep 2023
First submitted
24 Mar 2022
Last updated
13 Sep 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 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 12 inclusion and 13 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 13 Sep 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Phase 1: Characterize the effect of IBIO123 compared to placebo on safety and tolerability (time frame: Baseline to Day 7). 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?

On the ClinicalTrials.gov record for NCT05303376.

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 13 Sep 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
Clinical Trial NCT05303376 | AzTrials