Evaluation of Safety and Tolerability of COR-101 in Hospitalized Patients With Moderate to Severe COVID-19
- Registration Number
- NCT04674566
- Lead Sponsor
- Corat Therapeutics Gmbh
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 45
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 2 Placebo COR-101 mid dose 1 Cohort 3 COR-101 COR-101 mid dose 2 Cohort 3 Placebo COR-101 mid dose 2 Cohort 4 COR-101 COR-101 high dose Cohort 1 COR-101 COR-101 low dose Cohort 1 Placebo COR-101 low dose Cohort 2 COR-101 COR-101 mid dose 1 Cohort 4 Placebo COR-101 high dose
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 Secondary efficacy endpoint: Proportion of patients with disease progression through Day 28 Proportion of patients who are not alive or have respiratory failure
Assessment of PK parameter: Time to Cmax (tmax) for COR-101 through Day 60 Assessment of PK parameter: Clearance (CL) for COR-101 through Day 60 Assessment of PK parameter: AUC from time zero extrapolated to infinity (AUCinf) for COR-101 through Day 60 Secondary immunogenicity endpoint: Percentage of patients with detectable neutralizing antibodies to 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
Trial Locations
- Locations (1)
University Hospital Tübingen
🇩🇪Tübingen, Germany