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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04674566
Recruitment Status : Recruiting
First Posted : December 19, 2020
Last Update Posted : May 25, 2022
Sponsor:
Information provided by (Responsible Party):
Corat Therapeutics Gmbh

Study Description
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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

Study Design
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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
Actual Study Start Date : April 21, 2021
Estimated Primary Completion Date : October 30, 2022
Estimated Study Completion Date : October 30, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04674566


Contacts
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Contact: Marie-Ann Dhaen +4981313563724 m.dhaen@corat-therapeutics.com

Locations
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Germany
University Hospital Tübingen Recruiting
Tübingen, Germany
Contact: Helmut Salih         
Sponsors and Collaborators
Corat Therapeutics Gmbh
Investigators
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Principal Investigator: Helmut Salih University Hospital Tübingen
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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: May 25, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases