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

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ClinicalTrials.gov Identifier: NCT04674566
Recruitment Status : Not yet recruiting
First Posted : December 19, 2020
Last Update Posted : March 17, 2021
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Covid19 Drug: COR-101 Drug: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Estimated Study Start Date : April 1, 2021
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

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




Primary Outcome Measures :
  1. Proportion of patients with Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: through Day 28 ]
  2. Proportion of patients with Serious Adverse Events (SAEs) [ Time Frame: through Day 28 ]
  3. Proportion of patients with Adverse Events of Special Interest (AESI) [ Time Frame: through Day 28 ]

Secondary Outcome Measures :
  1. Secondary efficacy endpoint: Proportion of patients with disease progression [ Time Frame: through Day 28 ]
    Proportion of patients who are not alive or have respiratory failure

  2. Secondary efficacy endpoint: Time to negative RT-PCR for SARS-CoV-2 [ Time Frame: through Day 28 ]
  3. Assessment of pharmacokinetic (PK) parameter: maximum serum concentration observed (Cmax) of COR-101 [ Time Frame: through Day 60 ]
  4. Assessment of PK parameter: Time to Cmax (tmax) for COR-101 [ Time Frame: through Day 60 ]
  5. Assessment of PK parameter: AUC from time zero extrapolated to infinity (AUCinf) for COR-101 [ Time Frame: through Day 60 ]
  6. Assessment of PK parameter: Clearance (CL) for COR-101 [ Time Frame: through Day 60 ]
  7. Assessment of PK parameter: Mean residence time (MRT) of COR-101 [ Time Frame: through Day 60 ]
  8. Secondary PD endpoint: Change of the viral load of SARS-CoV-2 from baseline, as measured from nasopharyngeal swab samples by qRT-PCR [ Time Frame: through Day 21 ]
  9. Secondary immunogenicity endpoint: Percentage of patients with detectable neutralizing antibodies to COR-101 [ Time Frame: through Day 60 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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Responsible Party: Corat Therapeutics Gmbh
ClinicalTrials.gov Identifier: NCT04674566    
Other Study ID Numbers: COR-101/001
First Posted: December 19, 2020    Key Record Dates
Last Update Posted: March 17, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No