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

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04674566
• Other study ID #: COR-101/001
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: April 21, 2021
• Est. completion date: October 30, 2022

Study information

• Verified date: May 2022
• Source: Corat Therapeutics Gmbh
• Contact: Marie-Ann Dhaen
• Phone: +4981313563724
• Email: m.dhaen[@]corat-therapeutics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: October 30, 2022
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Drug:
• COR-101
Administered intravenously (IV) single dose
• Placebo
Administered intravenously (IV) single dose

Locations

Country	Name	City	State
Germany	University Hospital Tübingen	Tübingen

Sponsors (1)

Lead Sponsor	Collaborator
Corat Therapeutics Gmbh

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with Treatment-Emergent Adverse Events (TEAEs)		through Day 28
Primary	Proportion of patients with Serious Adverse Events (SAEs)		through Day 28
Primary	Proportion of patients with Adverse Events of Special Interest (AESI)		through Day 28
Secondary	Secondary efficacy endpoint: Proportion of patients with disease progression	Proportion of patients who are not alive or have respiratory failure	through Day 28
Secondary	Secondary efficacy endpoint: Time to negative RT-PCR for SARS-CoV-2		through Day 28
Secondary	Assessment of pharmacokinetic (PK) parameter: maximum serum concentration observed (Cmax) of COR-101		through Day 60
Secondary	Assessment of PK parameter: Time to Cmax (tmax) for COR-101		through Day 60
Secondary	Assessment of PK parameter: AUC from time zero extrapolated to infinity (AUCinf) for COR-101		through Day 60
Secondary	Assessment of PK parameter: Clearance (CL) for COR-101		through Day 60
Secondary	Assessment of PK parameter: Mean residence time (MRT) of COR-101		through Day 60
Secondary	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	Secondary immunogenicity endpoint: Percentage of patients with detectable neutralizing antibodies to COR-101		through Day 60