Study in Adults to Assess the Safety and Efficacy of Inhaled IBIO123, for Post-exposure Prophylaxis of COVID-19

NCT05639166 | Completed Phase 2

• 1 other identifier: IBIO-INH-003
• Study Type: interventional
• Target: 200
• Locations: 2 countries
• Sites: 5

Brief Summary

This is a Phase 2, randomized, double-blind, multicentre, placebo-controlled study in adults to assess the safety and efficacy of inhaled IBIO123, for post-exposure prophylaxis of COVID-19. This study aims to evaluate the efficacy and the safety of IBIO123 and the prophylaxis effect of IBIO123 in participants exposed to COVID-19 in the setting of current and uninterrupted household contacts.

Conditions

COVID-19

Keywords

IBIO; IBIO123; Prophylaxis; Inhalation; monoclonal antibodies; Prevention

Outcome Measures

Primary Outcomes (1)

• Characterize the effect of IBIO123 compared to placebo on laboratory-confirmed COVID-19 infections between baseline and Day 14

  • Proportion of participants who had a laboratory-confirmed COVID-19 infection between baseline and Day 14

  From Baseline to Day 14

Secondary Outcomes (6)

• Characterize the effect of IBIO123 compared to placebo on laboratory-confirmed COVID-19 infections between baseline and Day 7

  From Baseline to Day 7

• Characterize the effect of IBIO123 compared to placebo on laboratory-confirmed COVID-19 asymptomatic infections between baseline and Day 7

  From Baseline to Day 7

• Characterize the effect of IBIO123 compared to placebo on laboratory-confirmed COVID-19 asymptomatic infections between baseline and Day 14

  From Baseline to Day 14

• Characterize the effect of IBIO123 compared to placebo on overall participant clinical status

  From Baseline to Day 14

• Characterize the effect of IBIO123 compared to placebo on SARS-CoV-2 related symptoms

  From Baseline to Day 14

Study Arms (2)

Active

EXPERIMENTAL

IBIO123 10 mg

Biological: IBIO123

Placebo

PLACEBO COMPARATOR

Matching Placebo

Other: Placebo

Interventions

IBIO123 BIOLOGICAL

IBIO123 10 mg

Active

Placebo OTHER

Matching Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are ≥18 years of age at the time of randomization
• Subject has a household contact with a confirmed COVID-19 cohabiting individual as subject. Initial diagnosis of the COVID-19 positive individual has been within 3 days of screening. COVID-19 positive result (PCR or Antigen) must have been performed by an accredited lab or medical professional. Current and uninterrupted household contacts were defined as family members or close relatives who had unprotected contact with the index case.
• Subject must have a negative result with the study provided rapid antigen test at baseline and be COVID-19 symptom free.
• Are men or non-pregnant women. Reproductive and Contraceptive agreements and guidance is provided in Appendix 2. Contraceptive use by men or women should be consistent with local regulations for those participating in clinical studies.
• Understand and agree to comply with planned study procedures
• Agree to the collection of nasopharyngeal swabs
• The participant or legally authorized representative gives signed informed consent as described in Section 10.1.1.2 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

You may not qualify if:

• A positive COVID-19 result (PCR or antigen test) within 30 days of screening.
• Presence of typical COVID-19 symptoms which cannot be explained by another underlying condition (fever \>38°C, Oxygen saturation (SpO2) below 93%, dyspnea, difficulty breathing, chills, ageusia, anosmia, cough, myalgia) in the past 48 hours prior to screening.
• Hypersensitivity to any component of IBIO123
• Participants who have been previously administered IBIO123.
• 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 pregnant or breast feeding
• Are investigator site personnel directly affiliated with this study.

Sponsors & Collaborators

• Immune Biosolutions Inc: lead

Study Sites (5)

Jongaie Research

Pretoria West, Pretoria, 0183, South Africa

Location

Central City Clinical Hospital of Chernivtsi City Council

Chernivtsi, Chernivetska, 58005, Ukraine

Location

City Clinical Hospital #1 of Ivano-Frankivsk City Council

Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018, Ukraine

Location

Central C.H. of Ivano-Frankivsk

Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76025, Ukraine

Location

Volyn Regional Clinical Hospital

Lutsk, Volyn Oblast, 43005, Ukraine

Location

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 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2022
• First Posted: December 6, 2022
• Study Start: February 18, 2023
• Primary Completion: May 16, 2023
• Study Completion: May 16, 2023
• Last Updated: May 22, 2023

Record last verified: 2023-05

Locations

ZA (1); UA (4)