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

Corat Therapeutics

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Covid19

Treatments: Drug: COR-101; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04674566

COR-101/001

Details and patient eligibility

About

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

Enrollment: 45 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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45 participants in 4 patient groups

Cohort 1

Experimental group

Description:

COR-101 low dose

Treatment:

Drug: Placebo

Drug: COR-101

Cohort 2

Experimental group

Description:

COR-101 mid dose 1

Treatment:

Drug: Placebo

Drug: COR-101

Cohort 3

Experimental group

Description:

COR-101 mid dose 2

Treatment:

Drug: Placebo

Drug: COR-101

Cohort 4

Experimental group

Description:

COR-101 high dose

Treatment:

Drug: Placebo

Drug: COR-101