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

NCT05298813 | Completed Phase 1 DMC

• 1 other identifier: IBIO-INH-001
• Study Type: interventional
• Target: 162
• Locations: 2 countries
• Sites: 11

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.

Conditions

COVID-19

Keywords

IBIO; IBIO123; mild COVID-19; moderate COVID-19; monoclonal antibodies; inhalation

Outcome Measures

Primary Outcomes (2)

• Phase 1 : Characterize the effect of IBIO123 compared to placebo on safety and tolerability

  Safety assessments such as AEs and SAEs

  From Baseline to Day 29

• 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

  From Baseline to Day 7

Secondary Outcomes (7)

• 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 SARS-CoV-2 viral load among participants with ≤8 days since symptom onset

  From Baseline to Day 7

• 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

Study Arms (2)

Active

EXPERIMENTAL

Biological: IBIO123

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

IBIO123 BIOLOGICAL

IBIO123 1 mg, 5 mg and 10 mg

Active

Placebo OTHER

Matching Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Immune Biosolutions Inc: lead

Study Sites (11)

Santa Casa de Misercórdia de Passos

Passos, Minas Gerais, 37900-512, Brazil

Location

Instituto Brasil de Pesquisa Clinica

Glória, Rio de Janeiro, 20.241-180, Brazil

Location

Clinica Supera Oncologia

Chapecó, Santa Catarina, 89801-355, Brazil

Location

Instituto Brasileiro de Controle do Câncer / Sao Camilo Oncologia

Pompéia, São Paulo, 05012-020, Brazil

Location

Pesquisare Saúde

Santo André, São Paulo, 09080-000, Brazil

Location

FARMOVS

Bloemfontein, Free State, 9301, South Africa

Location

Newton Clinical Trial Centre

Newtown, Gauteng, 2001, South Africa

Location

Johese Clinical Research ZAH

Pretoria, Gauteng, 0002, South Africa

Location

Jongaie Research

Pretoria West, Gauteng, 0183, South Africa

Location

Durban International Clinical Research, Enhancing Care Foundation

Durban, KwaZulu-Natal, 4052, South Africa

Location

Clinical Research Institute of South Africa - CRISA

KwaDukuza, KwaZulu-Natal, 4449, South Africa

Location

Related Publications (1)

• 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.

  PMID: 37619584 DERIVED

MeSH Terms

Conditions

COVID-19; Respiratory Aspiration

Interventions

IBIO123

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sebastien Labbe, PhD

  Immune Biosolutions

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2022
• First Posted: March 28, 2022
• Study Start: September 29, 2021
• Primary Completion: January 4, 2023
• Study Completion: January 4, 2023
• Last Updated: May 1, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (5); ZA (6)