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

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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Other: Placebo; Biological: IBIO123

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).

• Study Type: Interventional
• Enrollment (Actual): 162
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Brazil
  • Minas Gerais
    • Passos, Minas Gerais, Brazil, 37900-512
      • Santa Casa de Misercórdia de Passos
  • Rio De Janeiro
    • Gloria, Rio De Janeiro, Brazil, 20.241-180
      • Instituto Brasil de Pesquisa Clinica
  • Santa Catarina
    • Chapecó, Santa Catarina, Brazil, 89801-355
      • Clínica Supera Oncologia
  • Sao Paulo
    • Pompeia, Sao Paulo, Brazil, 05012-020
      • Instituto Brasileiro de Controle do Câncer / Sao Camilo Oncologia
    • Santo André, Sao Paulo, Brazil, 09080-000
      • Pesquisare Saude
• South Africa
  • Free State
    • Bloemfontein, Free State, South Africa, 9301
      • FARMOVS
  • Gauteng
    • Newtown, Gauteng, South Africa, 2001
      • Newton Clinical Trial Centre
    • Pretoria, Gauteng, South Africa, 0002
      • Johese Clinical Research ZAH
    • Pretoria West, Gauteng, South Africa, 0183
      • Jongaie Research
  • Kwazulu-Natal
    • Durban, Kwazulu-Natal, South Africa, 4052
      • Durban International Clinical Research, Enhancing Care Foundation
    • Stanger, Kwazulu-Natal, South Africa, 4449
      • Clinical Research Institute of South Africa - CRISA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; Matching Placebo
Experimental: Active	Biological: IBIO123; IBIO123 1 mg, 5 mg and 10 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characterize the effect of IBIO123 compared to placebo on overall participant clinical status	Proportion (percentage) of participants who experience these events by Day 29: COVID-19 related hospitalization (defined as ≥24 hours of acute care); a COVID-19 related emergency room visit, or death	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	Change from baseline to Day 7 in SARS-CoV-2 viral load among participants enrolled with ≤ 8 days of symptoms prior to randomization	From Baseline to Day 7
Characterize the effect of IBIO123 compared to placebo on Baseline SARS-CoV-2 related symptoms	• Time to symptom reduction or resolution and proportion of patients	From Baseline to Day 29
Characterize the effect of IBIO123 compared to placebo on SARS-CoV-2 viral load and viral clearance	• Proportion of participants who achieve SARS-CoV-2 clearance	From Baseline to Day 29
Characterize the pharmacokinetics of IBIO123	IBIO123 mean plasma concentration	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	Change from baseline to Day 7 in SARS-CoV-2 viral load	From Baseline to Day 7
Phase 2 : Characterize the effect of IBIO123 compared to placebo on safety and tolerability	Safety assessments such as AEs and SAEs	From Baseline to Day 29

Collaborators and Investigators

• Sponsor: Immune Biosolutions Inc

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2021
• Primary Completion (Actual): January 4, 2023
• Study Completion (Actual): January 4, 2023

Study Registration Dates

• First Submitted: March 23, 2022
• First Submitted That Met QC Criteria: March 24, 2022
• First Posted (Actual): March 28, 2022

Study Record Updates

• Last Update Posted (Actual): May 1, 2023
• Last Update Submitted That Met QC Criteria: April 28, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: inhalation; IBIO; IBIO123; monoclonal antibodies; mild COVID-19; moderate COVID-19
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: IBIO-INH-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No