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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.
This is a randomized, double-blind, multicentre, placebo-controlled study eligible patients will be randomized in a 1:1 ratio to receive either 10mg of IBIO123 or matching vehicle (placebo). IBIO123 will be administered by inhalation via an Aerogen Ultra mesh nebulizer according to the manufacturer's recommendation. Patients will be followed up for a total period of 14 days after the administration of study intervention to detect an infection to SARS-CoV-2.
This study will enroll a total of 140 participants (70 participants on IBIO123 & 70 participants on Placebo).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental | IBIO123 10 mg |
|
| Placebo | Placebo Comparator | Matching Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBIO123 | Biological | IBIO123 10 mg |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Characterize the effect of IBIO123 compared to placebo on laboratory-confirmed COVID-19 infections between baseline and Day 7 | Proportion of participants who had a laboratory-confirmed COVID-19 infection 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sebastien Labbe, PhD | Immune Biosolutions | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jongaie Research | Pretoria West | Pretoria | 0183 | South Africa | ||
| Central City Clinical Hospital of Chernivtsi City Council |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000722674 | IBIO123 |
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| Other |
Matching Placebo |
|
Proportion of participants who had a laboratory-confirmed asymptomatic COVID-19 infection 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 | Proportion of participants who had a laboratory-confirmed asymptomatic COVID-19 infection between baseline and Day 14 | From Baseline to Day 14 |
| Characterize the effect of IBIO123 compared to placebo on overall participant clinical status | Proportion (percentage) of participants who experience these events by Day 14
| From Baseline to Day 14 |
| Characterize the effect of IBIO123 compared to placebo on SARS-CoV-2 related symptoms |
| From Baseline to Day 14 |
| Characterize the effect of IBIO123 compared to placebo on safety and tolerability | Safety assessments such as adverse events (AEs) and Serious adverse events (SAEs) | From Baseline to Day 14 |
| Chernivtsi |
| Chernivetska |
| 58005 |
| Ukraine |
| City Clinical Hospital #1 of Ivano-Frankivsk City Council | Ivano-Frankivsk | Ivano-Frankivsk Oblast | 76018 | Ukraine |
| Central C.H. of Ivano-Frankivsk | Ivano-Frankivsk | Ivano-Frankivsk Oblast | 76025 | Ukraine |
| Volyn Regional Clinical Hospital | Lutsk | Volyn Oblast | 43005 | Ukraine |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |