Clinical trial NCT05298813: Phase 1/2 Study to Evaluate the Efficacy and Safety of Inhaled IBIO123 in Participants With Mild to Moderate COVID-19 Illness
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: COVID-19
Keywords: IBIO
IBIO123
mild COVID-19
moderate COVID-19
monoclonal antibodies
inhalation
Lead sponsor: Immune Biosolutions Inc
Sponsor class: INDUSTRY
First posted: 2022-03-28
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: Inclusion Criteria:

Age

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

   Disease Characteristics
2. Are currently not hospitalized
3. 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
4. Must have sample collection for first positive SARS-CoV-2 viral infection determination

   ≤3 days prior to start of the inhalation.

   Sex
5. 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
6. Understand and agree to comply with planned study procedures
7. Agree to the collection of nasopharyngeal swabs and venous blood Informed Consent
8. 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.

   Exclusion Criteria:

   Medical Conditions
9. Have SpO2 ≤ 93% on room air, respiratory rate ≥30 per minute, resting heart rate ≥125 per minute.
10. Require mechanical ventilation or anticipated impending need for mechanical ventilation
11. Have known allergies to any of the components used in the formulation of the interventions.
12. Have hemodynamic instability requiring use of pressors within 24 hours of randomization.
13. 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.
14. Have any co-morbidity requiring surgery or that is considered life- threatening within 29 days prior to dosing.
15. Have any serious concomitant systemic disease, condition or disorder that, in the opinion of the investigator, should preclude participation in this study.

    Other Exclusions
16. Have a history of a positive SARS-CoV-2 test prior to the one serving as eligibility for this study.
17. Have received an investigational intervention for SARS-CoV-2 prophylaxis within 30 days before dosing.
18. Have received treatment with a SARS-CoV-2 specific monoclonal antibody.
19. 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.
20. Are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
21. Are pregnant or breast feeding.
22. Are investigator site personnel directly affiliated with this study.

Primary outcomes:
measure: Phase 1 : Characterize the effect of IBIO123 compared to placebo on safety and tolerability
timeFrame: From Baseline to Day 29
measure: Phase 2: Characterize the effect of IBIO123 compared to placebo on SARS-CoV-2 viral load and viral clearance
timeFrame: From Baseline to Day 7
Secondary outcomes:
measure: Characterize the effect of IBIO123 compared to placebo on overall participant clinical status
timeFrame: From Baseline to Day 29
measure: Characterize the effect of IBIO123 compared to placebo on SARS-CoV-2 viral load among participants with ≤8 days since symptom onset
timeFrame: From Baseline to Day 7
measure: Characterize the effect of IBIO123 compared to placebo on Baseline SARS-CoV-2 related symptoms
timeFrame: From Baseline to Day 29
measure: Characterize the effect of IBIO123 compared to placebo on SARS-CoV-2 viral load and viral clearance
timeFrame: From Baseline to Day 29
measure: Characterize the pharmacokinetics of IBIO123
timeFrame: Days 1, 3, 7, and 29
measure: Phase 1: Characterize the effect of IBIO123 compared to placebo on SARS-CoV-2 viral load and viral clearance
timeFrame: From Baseline to Day 7
measure: Phase 2 : Characterize the effect of IBIO123 compared to placebo on safety and tolerability
timeFrame: From Baseline to Day 29
Other outcomes:
Locations:
city: Passos
country: Brazil
facility: Santa Casa de Misercórdia de Passos
state: Minas Gerais
city: Gloria
country: Brazil
facility: Instituto Brasil de Pesquisa Clinica
state: Rio De Janeiro
city: Chapecó
country: Brazil
facility: Clinica Supera Oncologia
state: Santa Catarina
city: Pompeia
country: Brazil
facility: Instituto Brasileiro de Controle do Câncer / Sao Camilo Oncologia
state: Sao Paulo
city: Santo André
country: Brazil
facility: Pesquisare Saúde
state: Sao Paulo
city: Bloemfontein
country: South Africa
facility: FARMOVS
state: Free State
city: Newtown
country: South Africa
facility: Newton Clinical Trial Centre
state: Gauteng
city: Pretoria West
country: South Africa
facility: Jongaie Research
state: Gauteng
city: Pretoria
country: South Africa
facility: Johese Clinical Research ZAH
state: Gauteng
city: Durban
country: South Africa
facility: Durban International Clinical Research, Enhancing Care Foundation
state: Kwazulu-Natal
city: Stanger
country: South Africa
facility: Clinical Research Institute of South Africa - CRISA
state: Kwazulu-Natal
Study officials:
affiliation: Immune Biosolutions
name: Sebastien Labbe, PhD
role: STUDY_DIRECTOR
References: