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 | NCT04488081 |
|
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
|
|
Contact
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
p.henderson@quantumleaphealth.org |
|
Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2020-07-27 |
|
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 |
Parallel |
|
Masking
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Open label |
|
Center
Last imported at : March 15, 2023, 4 a.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 : June 25, 2021, 2 a.m. Source : ClinicalTrials.gov |
inclusion criteria: a. male or female, at least 18 years old. b. admitted to the hospital and placed on high flow oxygen (greater than 6l by nasal cannula or mask delivery system) or intubated for the treatment of (established or presumed) covid-19. c. informed consent provided by the patient or health care proxy. d. confirmation of sars-cov-2 infection by pcr or rapid antigen testing for sars-cov-2 infection prior to randomization. |
|
Exclusion criteria
Last imported at : Oct. 17, 2022, 12:34 p.m. Source : ClinicalTrials.gov |
a. pregnant or breastfeeding women (must be documented by a pregnancy test during hospitalization) b. history of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent based on review of the medical record and patient history. c. comfort measures only. d. acute liver disease, or chronic liver disease with a child-pugh score greater than 11. e. resident for more than six months at a skilled nursing facility. f. estimated mortality greater than 50% over the next six months from underlying chronic conditions. g. time since requirement for high flow oxygen or ventilation greater than 5 days. h. anticipated transfer to another hospital which is not a study site within 72 hours. i. patients with either end-stage kidney disease or acute kidney injury who are on dialysis. j. co-enrollment in clinical trials of pharmacologic agents requiring an ind k. on 3 or more vasopressors l. pre-existing heart failure with a known left ventricular ejection fraction <25% or unstable angina pectoris |
|
Number of arms
Last imported at : Oct. 17, 2022, 12:34 p.m. Source : ClinicalTrials.gov |
12 |
|
Funding
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
QuantumLeap Healthcare Collaborative |
|
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 |
100 |
|
Countries
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
United States |
|
Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Critical disease at enrollment |
|
Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
8: Critical disease at enrollment |
|
Total sample size
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
1500 |
|
primary outcome
Last imported at : Oct. 17, 2022, 12:34 p.m. Source : ClinicalTrials.gov |
Identify agents that will result in substantial improvements to the clinical condition of participants with severe COVID-19;Mortality |
|
Notes
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : Feb. 25, 2021, 7:58 p.m. Source : ClinicalTrials.gov |
Phase 2 |
|
Arms
Last imported at : Oct. 17, 2022, 12:34 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "nan", "treatment_id": 631, "treatment_name": "Imatinib", "treatment_type": "Kinase inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 263, "treatment_name": "Cenicriviroc", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 621, "treatment_name": "Icatibant", "treatment_type": "Cardiovascular agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 112, "treatment_name": "Apremilast", "treatment_type": "Other targeted therapies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 416, "treatment_name": "Dornase alfa", "treatment_type": "Respiratory agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 1991, "treatment_name": "Celecoxib+famotidine", "treatment_type": "Non-steroidal anti-inflammatory+others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 2625, "treatment_name": "Ic14", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 1872, "treatment_name": "Narsoplimab", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 154, "treatment_name": "Aviptadil", "treatment_type": "Cardiovascular agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 368, "treatment_name": "Cyproheptadine hydrochloride", "treatment_type": "Respiratory agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 283, "treatment_name": "Ciclosporin", "treatment_type": "Immunosuppressants", "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"}] |