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Trial - NCT04674566


Column Value
Trial registration number NCT04674566
Full text link
Last imported at : Dec. 21, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04674566

First author
Last imported at : May 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Marie-Ann Dhaen

Contact
Last imported at : May 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

m.dhaen@corat-therapeutics.com

Registration date
Last imported at : Dec. 23, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

2020-12-19

Recruitment status
Last imported at : May 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Recruiting

Study design
Last imported at : Dec. 21, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Dec. 21, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Dec. 21, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Dec. 21, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : Dec. 21, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Dec. 21, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

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
Last imported at : Dec. 21, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

- 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

Number of arms
Last imported at : Dec. 21, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

5

Funding
Last imported at : Dec. 21, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Corat Therapeutics Gmbh

Inclusion age min
Last imported at : Dec. 21, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Dec. 21, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : May 19, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Germany

Type of patients
Last imported at : Dec. 21, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Moderate/severe disease at enrollment

Severity scale
Last imported at : Dec. 21, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

4: Moderate/severe disease at enrollment

Total sample size
Last imported at : Dec. 21, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

45

primary outcome
Last imported at : Dec. 21, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Proportion of patients with Adverse Events of Special Interest (AESI);Proportion of patients with Serious Adverse Events (SAEs);Proportion of patients with Treatment-Emergent Adverse Events (TEAEs)

Notes
Last imported at : Dec. 21, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Phase 1/Phase 2

Arms
Last imported at : Dec. 21, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "Low dose", "treatment_id": 323, "treatment_name": "Cor-101", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "mid dose 1", "treatment_id": 323, "treatment_name": "Cor-101", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "mid dose 2", "treatment_id": 323, "treatment_name": "Cor-101", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "high dose", "treatment_id": 323, "treatment_name": "Cor-101", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]