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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
200
Jongaie Research
Pretoria West, Pretoria, South Africa
Central City Clinical Hospital of Chernivtsi City Council
Chernivtsi, Chernivetska, Ukraine
City Clinical Hospital #1 of Ivano-Frankivsk City Council
Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine
Central C.H. of Ivano-Frankivsk
Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine
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
Time frame: From Baseline to Day 14
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
Time frame: 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
Proportion of participants who had a laboratory-confirmed asymptomatic COVID-19 infection between baseline and Day 7
Time frame: 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
Time frame: 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 * Hospitalisation * Mortality
Time frame: From Baseline to Day 14
Characterize the effect of IBIO123 compared to placebo on SARS-CoV-2 related symptoms
* Time to symptom onset * Proportion of participants demonstrating symptom resolution on Days 7 \& 14. * Proportion of participants demonstrating Mild, Moderate and Severe symptoms between baseline to Day 7 and day 14
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Volyn Regional Clinical Hospital
Lutsk, Volyn Oblast, Ukraine
Time frame: 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)
Time frame: From Baseline to Day 14