This is a Phase 1 and phase 2, adaptive, placebo-controlled, double-blind, randomized single-dose study in participants with Severe COVID-19 illness.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
123
JOHESE UNITAS Hospital
Lyttelton, Centurion, South Africa
JOHESE ZAH Hospital
Pretoria, Gauteng, South Africa
Central City Clinical Hospital of Ivano-Frankivsk City Council
Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine
City Clinical Hospital #1 of Ivano-Frankivsk City Council
Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine
Phase 1: Characterize the effect of IBIO123 compared to placebo on safety and tolerability
• Safety assessments such as AEs and SAEs
Time frame: Baseline to Day 7
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
Time frame: Baseline to Day 5
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
Time frame: Baseline to Day 7
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
Time frame: Baseline to Day 29
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
Time frame: Baseline to Day 29
Phase 2: Characterize the effect of IBIO123 compared to placebo on safety and tolerability
• Safety assessments such as AEs and SAEs
Time frame: Baseline to Day 29
Phase 2: Characterize the effect of IBIO123 compared to placebo on length of stay in hospital
• Mean duration of hospitalisation and ICU care (days)
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Hospital №1" of the Zhytomyr City Council
Zhytomyr, Zhytomyr Oblast, Ukraine
Time frame: Baseline to Day 29
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)
Time frame: Baseline to Day 29
Phase 2: Characterize the pharmacokinetics of IBIO123
IBIO123 mean plasma concentration
Time frame: Days 1, 3, 7 and 29
Phase 2: Characterize the immunogenicity of IBIO123
Assessment of Anti-drug antibodies of IBIO123 at Day 1 and 29
Time frame: Baseline to Day 29