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

Primary Purpose

Covid19

Status

Recruiting

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

COR-101

Placebo

About this trial

This is an interventional treatment trial for Covid19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University Hospital TübingenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Cohort 1

Cohort 2

Cohort 3

Cohort 4

Arm Description

COR-101 low dose

COR-101 mid dose 1

COR-101 mid dose 2

COR-101 high dose

Outcomes

Primary Outcome Measures

Proportion of patients with Treatment-Emergent Adverse Events (TEAEs)

Proportion of patients with Serious Adverse Events (SAEs)

Proportion of patients with Adverse Events of Special Interest (AESI)

Secondary Outcome Measures

Secondary efficacy endpoint: Proportion of patients with disease progression

Proportion of patients who are not alive or have respiratory failure

Secondary efficacy endpoint: Time to negative RT-PCR for SARS-CoV-2

Assessment of pharmacokinetic (PK) parameter: maximum serum concentration observed (Cmax) of COR-101

Assessment of PK parameter: Time to Cmax (tmax) for COR-101

Assessment of PK parameter: AUC from time zero extrapolated to infinity (AUCinf) for COR-101

Assessment of PK parameter: Clearance (CL) for COR-101

Assessment of PK parameter: Mean residence time (MRT) of COR-101

Secondary PD endpoint: Change of the viral load of SARS-CoV-2 from baseline, as measured from nasopharyngeal swab samples by qRT-PCR

Secondary immunogenicity endpoint: Percentage of patients with detectable neutralizing antibodies to COR-101

Full Information

NCT ID

NCT04674566

First Posted

December 17, 2020

Last Updated

May 24, 2022

Sponsor

Corat Therapeutics Gmbh

1. Study Identification

Unique Protocol Identification Number

NCT04674566

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Recruiting

Study Start Date

April 21, 2021 (Actual)

Primary Completion Date

October 30, 2022 (Anticipated)

Study Completion Date

October 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Corat Therapeutics Gmbh

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid19

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1

Arm Type

Experimental

Arm Description

COR-101 low dose

Arm Title

Cohort 2

Arm Type

Experimental

Arm Description

COR-101 mid dose 1

Arm Title

Cohort 3

Arm Type

Experimental

Arm Description

COR-101 mid dose 2

Arm Title

Cohort 4

Arm Type

Experimental

Arm Description

COR-101 high dose

Intervention Type

Drug

Intervention Name(s)

COR-101

Intervention Description

Administered intravenously (IV) single dose

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Administered intravenously (IV) single dose

Primary Outcome Measure Information:

Title

Proportion of patients with Treatment-Emergent Adverse Events (TEAEs)

Time Frame

through Day 28

Title

Proportion of patients with Serious Adverse Events (SAEs)

Time Frame

through Day 28

Title

Proportion of patients with Adverse Events of Special Interest (AESI)

Time Frame

through Day 28

Secondary Outcome Measure Information:

Title

Secondary efficacy endpoint: Proportion of patients with disease progression

Description

Proportion of patients who are not alive or have respiratory failure

Time Frame

through Day 28

Title

Secondary efficacy endpoint: Time to negative RT-PCR for SARS-CoV-2

Time Frame

through Day 28

Title

Assessment of pharmacokinetic (PK) parameter: maximum serum concentration observed (Cmax) of COR-101

Time Frame

through Day 60

Title

Assessment of PK parameter: Time to Cmax (tmax) for COR-101

Time Frame

through Day 60

Title

Assessment of PK parameter: AUC from time zero extrapolated to infinity (AUCinf) for COR-101

Time Frame

through Day 60

Title

Assessment of PK parameter: Clearance (CL) for COR-101

Time Frame

through Day 60

Title

Assessment of PK parameter: Mean residence time (MRT) of COR-101

Time Frame

through Day 60

Title

Secondary PD endpoint: Change of the viral load of SARS-CoV-2 from baseline, as measured from nasopharyngeal swab samples by qRT-PCR

Time Frame

through Day 21

Title

Secondary immunogenicity endpoint: Percentage of patients with detectable neutralizing antibodies to COR-101

Time Frame

through Day 60

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Marie-Ann Dhaen

Phone

+4981313563724

m.dhaen@corat-therapeutics.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Helmut Salih

Organizational Affiliation

University Hospital Tübingen

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital Tübingen

City

Tübingen

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Helmut Salih

12. IPD Sharing Statement

Citations:

PubMed Identifier

34473343

Citation

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.

Results Reference

derived

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

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