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Trial - NCT05614349


Column Value
Trial registration number NCT05614349
Full text link
Last imported at : Nov. 17, 2022, 4 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT05614349

First author
Last imported at : Nov. 17, 2022, 4 a.m.
Source : ClinicalTrials.gov

Andrew Pinto, MD FRCPC

Contact
Last imported at : Nov. 17, 2022, 4 a.m.
Source : ClinicalTrials.gov

benita.hosseini@unityhealth.to

Registration date
Last imported at : Nov. 17, 2022, 4 a.m.
Source : ClinicalTrials.gov

2022-11-14

Recruitment status
Last imported at : Feb. 14, 2023, noon
Source : ClinicalTrials.gov

Recruiting

Study design
Last imported at : Nov. 17, 2022, 4 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Nov. 17, 2022, 4 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Nov. 17, 2022, 4 a.m.
Source : ClinicalTrials.gov

Adaptive

Masking
Last imported at : Nov. 17, 2022, 4 a.m.
Source : ClinicalTrials.gov

Open label

Center
Last imported at : July 8, 2023, 8 a.m.
Source : ClinicalTrials.gov

multi-center

Study aim
Last imported at : Nov. 17, 2022, 4 a.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Nov. 17, 2022, 4 a.m.
Source : ClinicalTrials.gov

inclusion criteria: age 50 years and older or 18-49 with 1 or more chronic high-risk medical conditions, and/or immunosuppression: chronic respiratory disease (including copd, cystic fibrosis and asthma requiring at least daily use of preventative and/or reliever medication); chronic heart or vascular disease; chronic kidney disease; chronic liver disease; chronic neurological disease (including dementia, stroke, epilepsy); severe and profound learning disability; down's syndrome; diabetes (type 1 or type 2); immunosuppression: primary (e.g. inherited immune disorders resulting from genetic mutations) or secondary due to disease or treatment (e.g. sickle cell, hiv, cancer, chemotherapy); solid organ, bone marrow and stem cell transplant recipients; morbid obesity (bmi >35); severe mental illness; care home resident. confirmed sars-cov-2 by nucleic acid testing or rapid antigen testing with proof of a positive test provided via a picture of the result able to be enrolled and begin the study therapeutic within 5 days of onset of symptoms associated with sars-cov-2 infection

Exclusion criteria
Last imported at : Nov. 17, 2022, 4 a.m.
Source : ClinicalTrials.gov

admitted to hospital or in an ed for more than 24 hours previously randomized to cantreatcovid currently participating in a clinical trial of a therapeutic agent for acute sars-cov-2 infection that is not/suspected not compatible with the study therapeutics already taking a study therapeutic or contraindication to a study therapeutic inability for participant or caregiver to provide informed consent paxlovid

Number of arms
Last imported at : Nov. 17, 2022, 4 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Nov. 17, 2022, 4 a.m.
Source : ClinicalTrials.gov

Unity Health Toronto

Inclusion age min
Last imported at : Nov. 17, 2022, 4 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Nov. 17, 2022, 4 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Nov. 17, 2022, 4 a.m.
Source : ClinicalTrials.gov

Canada

Type of patients
Last imported at : Nov. 17, 2022, 4 a.m.
Source : ClinicalTrials.gov

Mild disease at enrollment

Severity scale
Last imported at : Nov. 17, 2022, 4 a.m.
Source : ClinicalTrials.gov

1: Mild disease at enrollment

Total sample size
Last imported at : Nov. 17, 2022, 4 a.m.
Source : ClinicalTrials.gov

12000

primary outcome
Last imported at : Nov. 17, 2022, 4 a.m.
Source : ClinicalTrials.gov

All-cause hospitalization or death rate;Time to recovery

Notes
Last imported at : Nov. 17, 2022, 4 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Nov. 17, 2022, 4 a.m.
Source : ClinicalTrials.gov

Phase 3

Arms
Last imported at : Nov. 17, 2022, 4 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "nan", "treatment_id": 2421, "treatment_name": "Nirmatrelvir+ritonavir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]