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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- COVID-19
- Sponsor
- Immune Biosolutions Inc
- Enrollment
- 162
- Locations
- 11
- Primary Endpoint
- Phase 2: Characterize the effect of IBIO123 compared to placebo on SARS-CoV-2 viral load and viral clearance
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief 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.
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •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:
- •i. Fever ii. Cough iii. Sore throat iv. Malaise v. Headache vi. Muscle pain vii. Gastrointestinal symptoms, or viii. Shortness of breath with exertion
- •Must have sample collection for first positive SARS-CoV-2 viral infection determination
- •≤3 days prior to start of the inhalation.
- •Are men or non-pregnant women Reproductive and Contraceptive agreements and guidance is provided in Section 10.4, Appendix
- •Contraceptive use by men or women should be consistent with local regulations for those participating in clinical studies.
- •Study Procedures
Exclusion Criteria
- •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.
- •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.
Outcomes
Primary Outcomes
Phase 2: Characterize the effect of IBIO123 compared to placebo on SARS-CoV-2 viral load and viral clearance
Time Frame: From Baseline to Day 7
Change from baseline to Day 7 in SARS-CoV-2 viral load
Phase 1 : Characterize the effect of IBIO123 compared to placebo on safety and tolerability
Time Frame: From Baseline to Day 29
Safety assessments such as AEs and SAEs
Secondary Outcomes
- Characterize the effect of IBIO123 compared to placebo on overall participant clinical status(From Baseline to Day 29)
- Characterize the effect of IBIO123 compared to placebo on Baseline SARS-CoV-2 related symptoms(From Baseline to Day 29)
- Characterize the effect of IBIO123 compared to placebo on SARS-CoV-2 viral load and viral clearance(From Baseline to Day 29)
- Characterize the pharmacokinetics of IBIO123(Days 1, 3, 7, and 29)
- Phase 1: Characterize the effect of IBIO123 compared to placebo on SARS-CoV-2 viral load and viral clearance(From Baseline to Day 7)
- Phase 2 : Characterize the effect of IBIO123 compared to placebo on safety and tolerability(From Baseline to Day 29)
- Characterize the effect of IBIO123 compared to placebo on SARS-CoV-2 viral load among participants with ≤8 days since symptom onset(From Baseline to Day 7)