Evaluation of Safety and Tolerability of COR-101 in Hospitalized Patients With Moderate to Severe COVID-19

Study Overview
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Brief Summary
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Primary objectives Part 1: - To evaluate the safety and tolerability of COR-101 compared to placebo Secondary objectives Part 1: To evaluate the preliminary efficacy of COR-101 compared to placebo in hospitalized patients with moderate to severe COVID-19 To assess the pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of COR-101

Official Title
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Randomized, Double-blind, Placebo Controlled, Parallel Group, Multi-centre, First-in-human, Phase Ib/II Study to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Efficacy of COR-101 in Hospitalized Patients

Conditions
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Covid19

Intervention / Treatment
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* Drug: COR-101
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Hospitalized for COVID-19 illness for ≤72 hours Positive SARS-CoV-2 test by standard RT-PCR assay or equivalent test Presence of moderate to severe clinical signs indicative of moderate or severe illness with COVID19 prior to study treatment Key Exclusion Criteria: Diagnosis of asymptomatic COVID-19, mild COVID-19, or critical COVID-19 In the opinion of the investigator, is not likely to survive for >48 hours beyond Day 1 New onset stroke or seizure disorder during hospitalization and prior to Day 1 History of relevant CNS pathology or current relevant CNS pathology

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>COR-101 low dose | Drug: COR-101<br>* Administered intravenously (IV) single dose<br>Drug: Placebo<br>* Administered intravenously (IV) single dose<br>|
| Experimental: Cohort 2<br>COR-101 mid dose 1 | Drug: COR-101<br>* Administered intravenously (IV) single dose<br>Drug: Placebo<br>* Administered intravenously (IV) single dose<br>|
| Experimental: Cohort 3<br>COR-101 mid dose 2 | Drug: COR-101<br>* Administered intravenously (IV) single dose<br>Drug: Placebo<br>* Administered intravenously (IV) single dose<br>|
| Experimental: Cohort 4<br>COR-101 high dose | Drug: COR-101<br>* Administered intravenously (IV) single dose<br>Drug: Placebo<br>* Administered intravenously (IV) single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with Treatment-Emergent Adverse Events (TEAEs) |  | through Day 28 | 
| Proportion of patients with Serious Adverse Events (SAEs) |  | through Day 28 | 
| Proportion of patients with Adverse Events of Special Interest (AESI) |  | through Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary efficacy endpoint: Proportion of patients with disease progression | Proportion of patients who are not alive or have respiratory failure | through Day 28 | 
| Secondary efficacy endpoint: Time to negative RT-PCR for SARS-CoV-2 |  | through Day 28 | 
| Assessment of pharmacokinetic (PK) parameter: maximum serum concentration observed (Cmax) of COR-101 |  | through Day 60 | 
| Assessment of PK parameter: Time to Cmax (tmax) for COR-101 |  | through Day 60 | 
| Assessment of PK parameter: AUC from time zero extrapolated to infinity (AUCinf) for COR-101 |  | through Day 60 | 
| Assessment of PK parameter: Clearance (CL) for COR-101 |  | through Day 60 | 
| Assessment of PK parameter: Mean residence time (MRT) of COR-101 |  | through Day 60 | 
| Secondary PD endpoint: Change of the viral load of SARS-CoV-2 from baseline, as measured from nasopharyngeal swab samples by qRT-PCR |  | through Day 21 | 
| Secondary immunogenicity endpoint: Percentage of patients with detectable neutralizing antibodies to COR-101 |  | through Day 60 |