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COVID-19Phase 1/2NCT05298813

Phase 1/2 Study to Evaluate the Efficacy and Safety of Inhaled IBIO123 in Participants With Mild to Moderate COVID-19 Illness

A Phase 1/2 study testing IBIO123 in people with COVID-19, run by Immune Biosolutions Inc at 11 sites in 2 countries.

Completed

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

Official record
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Trial summary

This is a Phase 1/2, randomized, double-blind, placebo-controlled, single-dose escalating-dose study in participants with mild to moderate 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
162 participants
Where
11 sitesin 2 countries
Study dates
29 Sep 2021to 4 Jan 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 not hospitalized
  • Have one or more mild or moderate COVID-19 symptoms:
  • Fever ii. Cough iii. Sore throat iv. Malaise v. Headache vi. Muscle pain vii. Gastrointestinal symptoms, or viii. Shortness of breath with exertion
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  • Must have sample collection for first positive SARS-CoV-2 viral infection determination
  • ≤3 days prior to start of the inhalation.
  • Sex
  • Are men or non-pregnant women Reproductive and Contraceptive agreements and guidance is provided in Section 10.4, Appendix 4. 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 gives signed informed consent as described in Section 14.1.3 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Who cannot join

  • Medical Conditions
  • Have SpO2 ≤ 93% on room air, respiratory rate ≥30 per minute, resting heart rate ≥125 per minute.
  • Require mechanical ventilation or anticipated impending need for mechanical ventilation
  • Have known allergies to any of the components used in the formulation of the interventions.
  • Have hemodynamic instability requiring use of pressors within 24 hours of randomization.
  • 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.
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  • Have any co-morbidity requiring surgery or that is considered life- threatening within 29 days prior to dosing.
  • 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 a history of a positive SARS-CoV-2 test prior to the one serving as eligibility for this study.
  • Have received an investigational intervention for SARS-CoV-2 prophylaxis within 30 days before dosing.
  • 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

11 sites in 2 countries.

11 sites in 2 countries

South Africa6 sites

  • FARMOVS

    Bloemfontein, Free State, 9301

  • Durban International Clinical Research, Enhancing Care Foundation

    Durban, KwaZulu-Natal, 4052

  • Clinical Research Institute of South Africa - CRISA

    KwaDukuza, KwaZulu-Natal, 4449

  • Newton Clinical Trial Centre

    Newtown, Gauteng, 2001

  • Johese Clinical Research ZAH

    Pretoria, Gauteng, 0002

  • Jongaie Research

    Pretoria West, Gauteng, 0183

Other trials in South Africa

Brazil5 sites

  • Clinica Supera Oncologia

    Chapecó, Santa Catarina, 89801-355

  • Instituto Brasil de Pesquisa Clinica

    Glória, Rio de Janeiro, 20.241-180

  • Santa Casa de Misercórdia de Passos

    Passos, Minas Gerais, 37900-512

  • Instituto Brasileiro de Controle do Câncer / Sao Camilo Oncologia

    Pompéia, São Paulo, 05012-020

  • Pesquisare Saúde

    Santo André, São Paulo, 09080-000

Other trials in Brazil

About this study

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

This is a Phase 1/2, randomized, double-blind, placebo-controlled, single-dose escalating-dose study in participants with mild to moderate COVID-19 illness.

Read the detailed description

Participants will be randomized to placebo or IBIO123.

In the phase 1 portion of the study, a total of 24 patients will be enrolled in 3 cohorts of 8 patients each. Six (6) of the 8 patients in each cohort will receive IBIO123 and 2 patients will receive placebo. The first cohort will be dosed with 1 mg. Subsequent cohorts will receive 5 mg, and 10 mg of IBIO123 or matching placebo and will be dosed at least 1 week apart to allow for review of safety and tolerability data for each prior cohort.

In the phase 2 portion of the study, as dose levels in phase 1 are determined to be safe, these dose levels may be introduced in phase 2 of Study IBIO-INH-001. This table describes the planned treatment arms. The Phase 2 portion of the study will enroll a total of approximately 200 participants (150 participants on study drug \& 50 participants on Placebo).

Conditions
COVID-19
Being tested
IBIO123, Placebo
Keywords
IBIO, IBIO123, mild COVID-19, moderate COVID-19, monoclonal antibodies, inhalation
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 1 mg, 5 mg and 10 mg

  • PlaceboOther

    Matching Placebo

Study groups in NCT05298813
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: From Baseline to Day 29

  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 7 in SARS-CoV-2 viral load

    Measured: From Baseline to Day 7

Secondary outcomes (7)

  1. Characterize the effect of IBIO123 compared to placebo on overall participant clinical status

    Proportion (percentage) of participants who experience these events by Day 29:

    • COVID-19 related hospitalization (defined as ≥24 hours of acute care)
    • a COVID-19 related emergency room visit, or death

    Measured: From Baseline to Day 29

  2. Characterize the effect of IBIO123 compared to placebo on SARS-CoV-2 viral load among participants with ≤8 days since symptom onset

    Change from baseline to Day 7 in SARS-CoV-2 viral load among participants enrolled with ≤ 8 days of symptoms prior to randomization

    Measured: From Baseline to Day 7

  3. Characterize the effect of IBIO123 compared to placebo on Baseline SARS-CoV-2 related symptoms

    • Time to symptom reduction or resolution and proportion of patients

    Measured: From Baseline to Day 29

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

    • Proportion of participants who achieve SARS-CoV-2 clearance

    Measured: From Baseline to Day 29

  5. Characterize the pharmacokinetics of IBIO123

    IBIO123 mean plasma concentration

    Measured: Days 1, 3, 7, and 29

  6. 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 in SARS-CoV-2 viral load

    Measured: From Baseline to Day 7

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

    Safety assessments such as AEs and SAEs

    Measured: From 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 posted28 Mar 2022
  2. Study start29 Sep 2021
  3. Primary completion4 Jan 2023
  4. Study completion4 Jan 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
162 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05298813
Sponsor's protocol ID
IBIO-INH-001
Status last verified
Apr 2023
First submitted
23 Mar 2022
Last updated
1 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Maranda B, Labbe SM, Lurquin M, Brabant P, Fugere A, Larrivee JF, Grbic D, Leroux A, Leduc F, Finzi A, Gaudreau S, Swart Y; IBIO-INH-001 Investigators. Safety and efficacy of inhaled IBIO123 for mild-to-moderate COVID-19: a randomised, double-blind, dose-ascending, placebo-controlled, phase 1/2 trial. Lancet Infect Dis. 2024 Jan;24(1):25-35. doi: 10.1016/S1473-3099(23)00393-6. Epub 2023 Aug 21.

    PubMed 37619584

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 11 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 14 inclusion and 16 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 1 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 11 sites in South Africa, Brazil. 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: From Baseline to Day 29). 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 NCT05298813, which also lists 1 linked publication.

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 1 May 2023.

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