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

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04674566

Enrollment

Registered

2020-12-19

Start date

2021-04-21

Completion date

2022-10-30

Last updated

2022-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

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

Interventions

DRUGCOR-101

Administered intravenously (IV) single dose

DRUGPlacebo

Administered intravenously (IV) single dose

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

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

Measure	Time frame	Description
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	—
Secondary efficacy endpoint: Proportion of patients with disease progression	through Day 28	Proportion of patients who are not alive or have respiratory failure
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	—
Assessment of PK parameter: Mean residence time (MRT) of COR-101	through Day 60	—
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	—

Countries

Germany

Contacts

Primary ContactMarie-Ann Dhaen

m.dhaen@corat-therapeutics.com+4981313563724

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026