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Trial - NCT04724629


Column Value
Trial registration number NCT04724629
Full text link
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04724629

First author
Last imported at : July 29, 2022, 3:30 p.m.
Source : ClinicalTrials.gov

Not reported

Contact
Last imported at : July 29, 2022, 3:30 p.m.
Source : ClinicalTrials.gov

Not reported

Registration date
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2021-01-26

Recruitment status
Last imported at : July 29, 2022, 3:30 p.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Adaptive

Masking
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Open label

Center
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

multi-center

Study aim
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

inclusion criteria: positive result in the quantitative real-time pcr (qpcr) test for sars-cov-2 in the respiratory tract; pneumonia confirmed by chest imaging and respiratory rate ≥ 24 irpm (for adults) or o2 saturation <93% or no improvement in o2 saturation, despite oxygen supply or arterial hypotension; or changes in capillary filling time; or changes in the level of consciousness; or oliguria; important: the presence of increased respiratory rate or desaturation (items "a" and "b") are criteria for hospital admission. items "c" to "g" are considered criteria for icu admission following the recommendations of the são paulo state health secretariat, resolution ss-28 of 03-mar-2020, prepared by the hospital das clínicas of medical school-usp.

Exclusion criteria
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

- age <18 years; - refuse to sign the informed consent form; - patient's decision that their involvement is not in their interest; - severe known liver disease (eg cirrhosis, with aminotransferase levels> 5 times the reference value limit); - pregnancy or breastfeeding period; - severe bacterial infection; - severe diarrhea; - diverticulitis or intestinal perforation; - infection known as hiv; - presence of one of the following uncontrolled or unstable cardiovascular diseases: stroke, ecg confirmed acute ischemia or myocardial infarction and / or clinically significant dysrhythmia; • known history of gastrointestinal bleeding, uncontrolled peptic ulcer or uncontrolled duodenal ulcer; - known history of hemophilia or other bleeding disorders; - history of organ transplantation, congenital immunodeficiency;

Number of arms
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

4

Funding
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

University of Sao Paulo

Inclusion age min
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Brazil

Type of patients
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Moderate/severe/critical disease at enrollment

Severity scale
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

5: Moderate/severe/critical disease at enrollment

Total sample size
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

60

primary outcome
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Ordinal scale of seven World Health Organization (WHO) categories of IL-17 inhibitor versus low dose IL-2 versus indirect IL-6 inhibitor (colchicine) versus standard treatment in the treatment of severe COVID-19

Notes
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

None

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

Phase 3

Arms
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 310, "treatment_name": "Colchicine", "treatment_type": "Metabolic agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 696, "treatment_name": "Ixekizumab", "treatment_type": "Interleukin inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 54, "treatment_name": "Aldesleukin", "treatment_type": "Interleukins", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]