NCT04674566

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for phase_1 covid19

Timeline
Completed

Started Apr 2021

Longer than P75 for phase_1 covid19

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 19, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

April 21, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2022

Completed
Last Updated

May 25, 2022

Status Verified

May 1, 2022

Enrollment Period

1.5 years

First QC Date

December 17, 2020

Last Update Submit

May 24, 2022

Conditions

Covid19

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (9)

  • Secondary efficacy endpoint: Proportion of patients with disease progression

    through Day 28

  • 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

  • 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

  • +4 more secondary outcomes

Study Arms (4)

Cohort 1

EXPERIMENTAL

COR-101 low dose

Drug: COR-101Drug: Placebo

Cohort 2

EXPERIMENTAL

COR-101 mid dose 1

Drug: COR-101Drug: Placebo

Cohort 3

EXPERIMENTAL

COR-101 mid dose 2

Drug: COR-101Drug: Placebo

Cohort 4

EXPERIMENTAL

COR-101 high dose

Drug: COR-101Drug: Placebo

Interventions

COR-101DRUG

Administered intravenously (IV) single dose

Cohort 1Cohort 2Cohort 3Cohort 4
PlaceboDRUG

Administered intravenously (IV) single dose

Cohort 1Cohort 2Cohort 3Cohort 4

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Tübingen

Tübingen, Germany

RECRUITING

Related Publications (1)

  • 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.

    PMID: 34473343DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Helmut Salih

    University Hospital Tübingen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie-Ann Dhaen

CONTACT

+4981313563724m.dhaen@corat-therapeutics.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2020

First Posted

December 19, 2020

Study Start

April 21, 2021

Primary Completion

October 30, 2022

Study Completion

October 30, 2022

Last Updated

May 25, 2022

Record last verified: 2022-05

Locations

DE(1)