Evaluation of Safety and Tolerability of COR-101 in Hospitalized Patients With Moderate to Severe COVID-19
NCT ID: NCT04674566
Last Updated: 2022-05-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
45 participants
INTERVENTIONAL
2021-04-21
2022-10-30
Brief Summary
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\- 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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Cohort 1
COR-101 low dose
COR-101
Administered intravenously (IV) single dose
Placebo
Administered intravenously (IV) single dose
Cohort 2
COR-101 mid dose 1
COR-101
Administered intravenously (IV) single dose
Placebo
Administered intravenously (IV) single dose
Cohort 3
COR-101 mid dose 2
COR-101
Administered intravenously (IV) single dose
Placebo
Administered intravenously (IV) single dose
Cohort 4
COR-101 high dose
COR-101
Administered intravenously (IV) single dose
Placebo
Administered intravenously (IV) single dose
Interventions
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COR-101
Administered intravenously (IV) single dose
Placebo
Administered intravenously (IV) single dose
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Corat Therapeutics Gmbh
INDUSTRY
Responsible Party
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Principal Investigators
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Helmut Salih
Role: PRINCIPAL_INVESTIGATOR
University Hospital Tübingen
Locations
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University Hospital Tübingen
Tübingen, , Germany
Countries
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Central Contacts
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Facility Contacts
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Helmut Salih
Role: primary
References
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Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
Other Identifiers
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COR-101/001
Identifier Type: -
Identifier Source: org_study_id
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