Status:
COMPLETED
Phase 1/2 Study to Evaluate the Efficacy and Safety of Inhaled IBIO123 in Participants With Mild to Moderate 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 1/2, randomized, double-blind, placebo-controlled, single-dose escalating-dose study in participants with mild to moderate COVID-19 illness.
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 ...
Eligibility Criteria
Inclusion
- Age
- Are ≥18 years of age at the time of randomization
- Disease Characteristics
- Are currently not hospitalized
- 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
- Must have sample collection for first positive SARS-CoV-2 viral infection determination
- ≤3 days prior to start of the inhalation.
- Sex
- 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
- 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 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
- Medical Conditions
- Have SpO2 ≤ 93% on room air, respiratory rate ≥30 per minute, resting heart rate ≥125 per minute.
- Require mechanical ventilation or anticipated impending need for mechanical ventilation
- Have known allergies to any of the components used in the formulation of the interventions.
- Have hemodynamic instability requiring use of pressors within 24 hours of randomization.
- 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 or that is considered life- threatening within 29 days prior to dosing.
- 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 a history of a positive SARS-CoV-2 test prior to the one serving as eligibility for this study.
- Have received an investigational intervention for SARS-CoV-2 prophylaxis within 30 days before dosing.
- 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 :
September 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 4 2023
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT05298813
Start Date
September 29 2021
End Date
January 4 2023
Last Update
May 1 2023
Active Locations (11)
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1
Santa Casa de Misercórdia de Passos
Passos, Minas Gerais, Brazil, 37900-512
2
Instituto Brasil de Pesquisa Clinica
Glória, Rio de Janeiro, Brazil, 20.241-180
3
Clinica Supera Oncologia
Chapecó, Santa Catarina, Brazil, 89801-355
4
Instituto Brasileiro de Controle do Câncer / Sao Camilo Oncologia
Pompéia, São Paulo, Brazil, 05012-020