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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05298813
• Other study ID #: IBIO-INH-001
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: September 29, 2021
• Est. completion date: January 4, 2023

Study information

• Verified date: April 2023
• Source: Immune Biosolutions Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: January 4, 2023
• Est. primary completion date: January 4, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Biological:
• IBIO123
IBIO123 1 mg, 5 mg and 10 mg

Other:
• Placebo
Matching Placebo

Locations

Country	Name	City	State
Brazil	Clinica Supera Oncologia	Chapecó	Santa Catarina
Brazil	Instituto Brasil de Pesquisa Clinica	Gloria	Rio De Janeiro
Brazil	Santa Casa de Misercórdia de Passos	Passos	Minas Gerais
Brazil	Instituto Brasileiro de Controle do Câncer / Sao Camilo Oncologia	Pompeia	Sao Paulo
Brazil	Pesquisare Saúde	Santo André	Sao Paulo
South Africa	FARMOVS	Bloemfontein	Free State
South Africa	Durban International Clinical Research, Enhancing Care Foundation	Durban	Kwazulu-Natal
South Africa	Newton Clinical Trial Centre	Newtown	Gauteng
South Africa	Johese Clinical Research ZAH	Pretoria	Gauteng
South Africa	Jongaie Research	Pretoria West	Gauteng
South Africa	Clinical Research Institute of South Africa - CRISA	Stanger	Kwazulu-Natal

Sponsors (1)

Lead Sponsor	Collaborator
Immune Biosolutions Inc

Countries where clinical trial is conducted

Brazil,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Characterize the pharmacokinetics of IBIO123	IBIO123 mean plasma concentration	Days 1, 3, 7, and 29
Secondary	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
Secondary	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