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

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

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

Study Overview

• Status: Recruiting
• Conditions: Covid19
• Intervention / Treatment: Drug: COR-101; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Marie-Ann Dhaen; Phone Number: +4981313563724; Email: m.dhaen@corat-therapeutics.com

Study Locations

• Germany
  • Tübingen, Germany
    • Recruiting
    • University Hospital Tübingen
    • Contact: Helmut Salih

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Corat Therapeutics Gmbh
• Investigators: Principal Investigator: Helmut Salih, University Hospital Tübingen

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2021
• Primary Completion (Anticipated): October 30, 2022
• Study Completion (Anticipated): October 30, 2022

Study Registration Dates

• First Submitted: December 17, 2020
• First Submitted That Met QC Criteria: December 17, 2020
• First Posted (Actual): December 19, 2020

Study Record Updates

• Last Update Posted (Actual): May 25, 2022
• Last Update Submitted That Met QC Criteria: May 24, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: COR-101/001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No