search
Back to results

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

Primary Purpose

COVID-19

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
IBIO123
Placebo
Sponsored by
Immune Biosolutions Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring SARS-CoV-2, Monoclonal antibodies, Inhalation, IBIO, IBIO123, Severe, Hospitalized

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age

  1. Are ≥18 years of age at the time of randomization

    Disease Characteristics

  2. Are currently hospitalized since less or equal than 3 days for COVID-19 respiratory illness

  3. 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

  4. 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

  5. Understand and agree to comply with planned study procedures

  6. Agree to the collection of nasopharyngeal swabs and venous blood

    Informed Consent

  7. The participant or legally authorized representative give signed informed consent

    Exclusion Criteria:

    Medical Conditions

  8. COVID-19 onset of symptoms began more than 10 days before randomisation
  9. Currently intubated or intubation is planned within the next 24 hours
  10. Have known allergies to any of the components used in the formulation of the interventions
  11. 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
  12. Have any co-morbidity requiring surgery within <7 days, or that is considered life- threatening within 29 days

  13. Have any serious concomitant systemic disease, condition, or disorder that, in the opinion of the investigator, should preclude participation in this study.

    Other Exclusions

  14. Have received treatment with a SARS-CoV-2 specific monoclonal antibody
  15. 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.
  16. Are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
  17. Are pregnant or breast feeding
  18. Are investigator site personnel directly affiliated with this study

Sites / Locations

  • JOHESE UNITAS Hospital
  • JOHESE ZAH Hospital
  • Central City Clinical Hospital of Ivano-Frankivsk City Council
  • City Clinical Hospital #1 of Ivano-Frankivsk City Council
  • Hospital №1" of the Zhytomyr City Council

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Phase 1: Characterize the effect of IBIO123 compared to placebo on safety and tolerability
• Safety assessments such as AEs and SAEs
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

Secondary Outcome Measures

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
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
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
Phase 2: Characterize the effect of IBIO123 compared to placebo on safety and tolerability
• Safety assessments such as AEs and SAEs
Phase 2: Characterize the effect of IBIO123 compared to placebo on length of stay in hospital
• Mean duration of hospitalisation and ICU care (days)
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)
Phase 2: Characterize the pharmacokinetics of IBIO123
IBIO123 mean plasma concentration
Phase 2: Characterize the immunogenicity of IBIO123
Assessment of Anti-drug antibodies of IBIO123 at Day 1 and 29

Full Information

First Posted
March 24, 2022
Last Updated
September 10, 2023
Sponsor
Immune Biosolutions Inc
search

1. Study Identification

Unique Protocol Identification Number
NCT05303376
Brief Title
Phase 1&2 Study to Evaluate the Safety & Efficacy of Inhaled IBIO123 in Severe COVID-19 Illness
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
February 22, 2022 (Actual)
Primary Completion Date
June 27, 2023 (Actual)
Study Completion Date
June 27, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Immune Biosolutions Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
SARS-CoV-2, Monoclonal antibodies, Inhalation, IBIO, IBIO123, Severe, Hospitalized

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
123 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
IBIO123
Intervention Description
5 or 10 mg
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
matching placebo
Primary Outcome Measure Information:
Title
Phase 1: Characterize the effect of IBIO123 compared to placebo on safety and tolerability
Description
• Safety assessments such as AEs and SAEs
Time Frame
Baseline to Day 7
Title
Phase 2: Characterize the effect of IBIO123 compared to placebo on SARS-CoV-2 viral load and viral clearance
Description
• Change from baseline to Day 5 (± 2 days) in SARS-CoV-2 viral load
Time Frame
Baseline to Day 5
Secondary Outcome Measure Information:
Title
Phase 1: Characterize the effect of IBIO123 compared to placebo on SARS-CoV-2 viral load and viral clearance
Description
• Change from baseline to Day 7 (± 2 days) in SARS-CoV-2 viral load
Time Frame
Baseline to Day 7
Title
Phase 2: Characterize the effect of IBIO123 compared to placebo on COVID-19 clinical progression
Description
• Change over time from baseline to Day 29 (± 2 days) in COVID-19 WHO Clinical Progression Scale
Time Frame
Baseline to Day 29
Title
Phase 2: Characterize the effect of IBIO123 compared to placebo on overall participant clinical status
Description
• Proportion (percentage) of participants who experience these events by Day 29 ICU admission intubation Mortality Discharge from Hospitalisation
Time Frame
Baseline to Day 29
Title
Phase 2: Characterize the effect of IBIO123 compared to placebo on safety and tolerability
Description
• Safety assessments such as AEs and SAEs
Time Frame
Baseline to Day 29
Title
Phase 2: Characterize the effect of IBIO123 compared to placebo on length of stay in hospital
Description
• Mean duration of hospitalisation and ICU care (days)
Time Frame
Baseline to Day 29
Title
Phase 2: Characterize the effect of IBIO123 compared to placebo on oxygen supplementation and ventilation needs
Description
Mean duration of oxygen treatment (days) and Incidence of Intubation and Mean duration of Intubation (days)
Time Frame
Baseline to Day 29
Title
Phase 2: Characterize the pharmacokinetics of IBIO123
Description
IBIO123 mean plasma concentration
Time Frame
Days 1, 3, 7 and 29
Title
Phase 2: Characterize the immunogenicity of IBIO123
Description
Assessment of Anti-drug antibodies of IBIO123 at Day 1 and 29
Time Frame
Baseline to Day 29

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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 Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sebastien Labbe, PhD
Organizational Affiliation
Immune Biosolutions
Official's Role
Study Director
Facility Information:
Facility Name
JOHESE UNITAS Hospital
City
Lyttelton
State/Province
Centurion
ZIP/Postal Code
0157
Country
South Africa
Facility Name
JOHESE ZAH Hospital
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0002
Country
South Africa
Facility Name
Central City Clinical Hospital of Ivano-Frankivsk City Council
City
Ivano-Frankivs'k
State/Province
Ivano-Frankivsk Oblast
ZIP/Postal Code
76000
Country
Ukraine
Facility Name
City Clinical Hospital #1 of Ivano-Frankivsk City Council
City
Ivano-Frankivs'k
State/Province
Ivano-Frankivsk Oblast
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
Hospital №1" of the Zhytomyr City Council
City
Zhytomyr
State/Province
Zhytomyrs'ka Oblast
ZIP/Postal Code
10002
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs