Clinical trial NCT04674566: 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
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Covid19
Lead sponsor: Corat Therapeutics Gmbh
Sponsor class: INDUSTRY
First posted: 2020-12-19
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Proportion of patients with Treatment-Emergent Adverse Events (TEAEs)
timeFrame: through Day 28
measure: Proportion of patients with Serious Adverse Events (SAEs)
timeFrame: through Day 28
measure: Proportion of patients with Adverse Events of Special Interest (AESI)
timeFrame: through Day 28
Secondary outcomes:
measure: Secondary efficacy endpoint: Proportion of patients with disease progression
timeFrame: through Day 28
measure: Secondary efficacy endpoint: Time to negative RT-PCR for SARS-CoV-2
timeFrame: through Day 28
measure: Assessment of pharmacokinetic (PK) parameter: maximum serum concentration observed (Cmax) of COR-101
timeFrame: through Day 60
measure: Assessment of PK parameter: Time to Cmax (tmax) for COR-101
timeFrame: through Day 60
measure: Assessment of PK parameter: AUC from time zero extrapolated to infinity (AUCinf) for COR-101
timeFrame: through Day 60
measure: Assessment of PK parameter: Clearance (CL) for COR-101
timeFrame: through Day 60
measure: Assessment of PK parameter: Mean residence time (MRT) of COR-101
timeFrame: through Day 60
measure: Secondary PD endpoint: Change of the viral load of SARS-CoV-2 from baseline, as measured from nasopharyngeal swab samples by qRT-PCR
timeFrame: through Day 21
measure: Secondary immunogenicity endpoint: Percentage of patients with detectable neutralizing antibodies to COR-101
timeFrame: through Day 60
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: University Hospital Tübingen
Study officials:
affiliation: University Hospital Tübingen
name: Helmut Salih
role: PRINCIPAL_INVESTIGATOR
References:
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.