v3.0.7
Please consider this website is continuously evolving and still under development
to harmonize automatic data extraction and integrate manual data annotation.
| Column | Value |
|---|---|
| Trial registration number | NCT04330690 |
|
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : May 6, 2022, 5 a.m. Source : ClinicalTrials.gov |
|
|
Contact
Last imported at : May 6, 2022, 5 a.m. Source : ClinicalTrials.gov |
rob.fowler@sunnybrook.ca |
|
Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2020-04-01 |
|
Recruitment status
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Recruiting |
|
Study design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
RCT |
|
Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Randomized |
|
Design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Adaptive |
|
Masking
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Open label |
|
Center
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
multi-center |
|
Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : Aug. 19, 2022, 7:30 p.m. Source : ClinicalTrials.gov |
inclusion criteria: each participant must meet all of the following inclusion criteria to participate in this study: ≥ 18 years of age has laboratory-confirmed sars-cov-2 infection as determined by pcr, or other commercial or public health assay in any specimen, within 14 days prior to randomization. hospitalized at a participating centre primary reason for hospitalization or subsequent in-hospital illness is because of acute covid19 infection first admission for acute covid19 in addition, there will be the below intervention-specific inclusion: randomization who will have no other specific inclusion criteria. randomization lsalt will have no other specific inclusion criteria. randomization dex will have the following specific inclusion criteria on 10 days of steroid course and receiving any supplemental oxygen for 10 days |
|
Exclusion criteria
Last imported at : Aug. 19, 2022, 7:30 p.m. Source : ClinicalTrials.gov |
all participants meeting any of the following exclusion criteria at baseline will be excluded from participation in this study: anticipated transfer to another hospital, within 72 hours, which is not a study site expected to not survive beyond 24 hours receiving one of the study drugs at time of enrolment in addition, there will be the below intervention-specific exclusions: randomization who: these will be drug-specific exclusions; patients will still be eligible for randomization in randomization who to the other available study drugs (in randomization who or subsequent randomizations). artesunate: 1. known hypersensitivity to artesunate imatinib: pregnant or breastfeeding; known hypersensitivity to imatinib; liver transaminases (either alt or ast) > 5x upper limit of normal infliximab: known moderate or severe heart failure, per treating clinician, defined as new york heart association (nyha) class iii or iv known or suspected active tuberculosis known hypersensitivity to infliximab randomization lsalt: known hypersensitivity or prior use of lsalt peptide. pregnant or breastfeeding randomization dex: 1. receiving glucocorticoids for a specific, non-covid-19 indication |
|
Number of arms
Last imported at : Aug. 19, 2022, 7:30 p.m. Source : ClinicalTrials.gov |
6 |
|
Funding
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Sunnybrook Health Sciences Centre |
|
Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
None |
|
Countries
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Canada |
|
Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
No restriction on type of patients |
|
Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
0: No restriction on type of patients |
|
Total sample size
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2900 |
|
primary outcome
Last imported at : Aug. 19, 2022, 7:30 p.m. Source : ClinicalTrials.gov |
Randomization Dex- Clinical Status;Randomization LSALT- Respiratory support;Randomization WHO- Mortality |
|
Notes
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : April 5, 2022, 8:30 p.m. Source : ClinicalTrials.gov |
Phase 3 |
|
Arms
Last imported at : Aug. 19, 2022, 7:30 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "nan", "treatment_id": 121, "treatment_name": "Artesunate", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 400, "treatment_name": "Dexamethasone", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 631, "treatment_name": "Imatinib", "treatment_type": "Kinase inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 650, "treatment_name": "Infliximab", "treatment_type": "Other targeted therapies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 753, "treatment_name": "Lsalt peptide", "treatment_type": "Anti-inflammatories", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}] |