NCT05303376

Brief Summary

This is a Phase 1 and phase 2, adaptive, placebo-controlled, double-blind, randomized single-dose study in participants with Severe COVID-19 illness.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P75+ for phase_1 covid19

Timeline
Completed

Started Feb 2022

Typical duration for phase_1 covid19

Geographic Reach
2 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 22, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 24, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2023

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

1.3 years

First QC Date

March 24, 2022

Last Update Submit

September 10, 2023

Conditions

COVID-19

Keywords

SARS-CoV-2Monoclonal antibodiesInhalationIBIOIBIO123SevereHospitalized

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

    Baseline to Day 7

  • Phase 2: Characterize the effect of IBIO123 compared to placebo on SARS-CoV-2 viral load and viral clearance

    • Change from baseline to Day 5 (± 2 days) in SARS-CoV-2 viral load

    Baseline to Day 5

Secondary Outcomes (8)

  • Phase 1: Characterize the effect of IBIO123 compared to placebo on SARS-CoV-2 viral load and viral clearance

    Baseline to Day 7

  • Phase 2: Characterize the effect of IBIO123 compared to placebo on COVID-19 clinical progression

    Baseline to Day 29

  • Phase 2: Characterize the effect of IBIO123 compared to placebo on overall participant clinical status

    Baseline to Day 29

  • Phase 2: Characterize the effect of IBIO123 compared to placebo on safety and tolerability

    Baseline to Day 29

  • Phase 2: Characterize the effect of IBIO123 compared to placebo on length of stay in hospital

    Baseline to Day 29

  • +3 more secondary outcomes

Study Arms (2)

Active

EXPERIMENTAL
Biological: IBIO123

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

IBIO123BIOLOGICAL

5 or 10 mg

Active
PlaceboOTHER

matching placebo

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age
  • Are ≥18 years of age at the time of randomization
  • Disease Characteristics
  • Are currently hospitalized since less or equal than 3 days for COVID-19 respiratory illness
  • Must have a positive SARS-CoV-2 viral infection determination prior to randomisation. For the phase 2 portion of the study only, the test must be performed within 24 hours before randomisation. Test can be a PCR or an antigen test originated from the institution or any government approved testing site. If the original test result is greater than 24 hours from randomisation, a rapid antigen must be performed at bedside by the study team to determine eligibility
  • Sex
  • 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.
  • 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 give signed informed consent

You may not qualify if:

  • Medical Conditions
  • COVID-19 onset of symptoms began more than 10 days before randomisation
  • Currently intubated or intubation is planned within the next 24 hours
  • Have known allergies to any of the components used in the formulation of the interventions
  • 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 within \<7 days, or that is considered life- threatening within 29 days
  • Have any serious concomitant systemic disease, condition, or disorder that, in the opinion of the investigator, should preclude participation in this study.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

JOHESE UNITAS Hospital

Lyttelton, Centurion, 0157, South Africa

Location

JOHESE ZAH Hospital

Pretoria, Gauteng, 0002, South Africa

Location

Central City Clinical Hospital of Ivano-Frankivsk City Council

Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76000, Ukraine

Location

City Clinical Hospital #1 of Ivano-Frankivsk City Council

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

Location

Hospital №1" of the Zhytomyr City Council

Zhytomyr, Zhytomyr Oblast, 10002, Ukraine

Location

MeSH Terms

Conditions

COVID-19Respiratory AspirationLymphoma, Follicular

Interventions

IBIO123

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesRespiration DisordersPathologic ProcessesPathological Conditions, Signs and SymptomsLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

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 24, 2022

First Posted

March 31, 2022

Study Start

February 22, 2022

Primary Completion

June 27, 2023

Study Completion

June 27, 2023

Last Updated

September 13, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

ZA(2)UA(3)