Status:
COMPLETED
Phase 1&2 Study to Evaluate the Safety & Efficacy of Inhaled IBIO123 in Severe COVID-19 Illness
Lead Sponsor:
Immune Biosolutions Inc
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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.
Detailed Description
In Phase 1, in hospital in a continuous observation setting the first cohort will recruit a total of 8 participants who will receive a single inhaled administration of the study treatment. This cohort...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
- Other Exclusions
- 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
Key Trial Info
Start Date :
February 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 27 2023
Estimated Enrollment :
123 Patients enrolled
Trial Details
Trial ID
NCT05303376
Start Date
February 22 2022
End Date
June 27 2023
Last Update
September 13 2023
Active Locations (5)
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1
JOHESE UNITAS Hospital
Lyttelton, Centurion, South Africa, 0157
2
JOHESE ZAH Hospital
Pretoria, Gauteng, South Africa, 0002
3
Central City Clinical Hospital of Ivano-Frankivsk City Council
Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine, 76000
4
City Clinical Hospital #1 of Ivano-Frankivsk City Council
Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine, 76018