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.
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 cohort will receive IBIO123 and 2 patients will receive placebo. The first cohort will be dosed with 1 mg. Subsequent cohorts will receive 5 mg, and 10 mg of IBIO123 or matching placebo and will be dosed at least 1 week apart to allow for review of safety and tolerability data for each prior cohort. In the phase 2 portion of the study, as dose levels in phase 1 are determined to be safe, these dose levels may be introduced in phase 2 of Study IBIO-INH-001. This table describes the planned treatment arms. The Phase 2 portion of the study will enroll a total of approximately 200 participants (150 participants on study drug \& 50 participants on Placebo).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
162
Santa Casa de Misercórdia de Passos
Passos, Minas Gerais, Brazil
Instituto Brasil de Pesquisa Clinica
Glória, Rio de Janeiro, Brazil
Clinica Supera Oncologia
Chapecó, Santa Catarina, Brazil
Phase 1 : Characterize the effect of IBIO123 compared to placebo on safety and tolerability
Safety assessments such as AEs and SAEs
Time frame: From Baseline to Day 29
Phase 2: Characterize the effect of IBIO123 compared to placebo on SARS-CoV-2 viral load and viral clearance
Change from baseline to Day 7 in SARS-CoV-2 viral load
Time frame: From Baseline to Day 7
Characterize the effect of IBIO123 compared to placebo on overall participant clinical status
Proportion (percentage) of participants who experience these events by Day 29: * COVID-19 related hospitalization (defined as ≥24 hours of acute care) * a COVID-19 related emergency room visit, or death
Time frame: From Baseline to Day 29
Characterize the effect of IBIO123 compared to placebo on SARS-CoV-2 viral load among participants with ≤8 days since symptom onset
Change from baseline to Day 7 in SARS-CoV-2 viral load among participants enrolled with ≤ 8 days of symptoms prior to randomization
Time frame: From Baseline to Day 7
Characterize the effect of IBIO123 compared to placebo on Baseline SARS-CoV-2 related symptoms
• Time to symptom reduction or resolution and proportion of patients
Time frame: From Baseline to Day 29
Characterize the effect of IBIO123 compared to placebo on SARS-CoV-2 viral load and viral clearance
• Proportion of participants who achieve SARS-CoV-2 clearance
Time frame: From Baseline to Day 29
Characterize the pharmacokinetics of IBIO123
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Instituto Brasileiro de Controle do Câncer / Sao Camilo Oncologia
Pompéia, São Paulo, Brazil
Pesquisare Saúde
Santo André, São Paulo, Brazil
FARMOVS
Bloemfontein, Free State, South Africa
Newton Clinical Trial Centre
Newtown, Gauteng, South Africa
Johese Clinical Research ZAH
Pretoria, Gauteng, South Africa
Jongaie Research
Pretoria West, Gauteng, South Africa
Durban International Clinical Research, Enhancing Care Foundation
Durban, KwaZulu-Natal, South Africa
...and 1 more locations
IBIO123 mean plasma concentration
Time frame: Days 1, 3, 7, and 29
Phase 1: Characterize the effect of IBIO123 compared to placebo on SARS-CoV-2 viral load and viral clearance
Change from baseline to Day 7 in SARS-CoV-2 viral load
Time frame: From Baseline to Day 7
Phase 2 : Characterize the effect of IBIO123 compared to placebo on safety and tolerability
Safety assessments such as AEs and SAEs
Time frame: From Baseline to Day 29