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Trial - NCT04485429


Column Value
Trial registration number NCT04485429
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04485429

First author
Last imported at : Aug. 12, 2021, 4 p.m.
Source : ClinicalTrials.gov

Eduardo M Rego, MD, PhD

Contact
Last imported at : Aug. 12, 2021, 4 p.m.
Source : ClinicalTrials.gov

edumrego@hotmail.com

Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-07-24

Recruitment status
Last imported at : Aug. 12, 2021, 4 p.m.
Source : ClinicalTrials.gov

Withdrawn

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

Factorial

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

single-center

Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

inclusion criteria: - confirmed diagnosis of covid-19 by rt-pcr or serology with presence of igm positive antibodies; - lung image (x-ray or chest ct) with involvement of at least 25% of the parenchyma; - o2 saturation in ambient air less than or equal to 93% - alteration of inflammatory tests - d-dimer above the reference value and - elevation of c-reactive protein, ferritin or lactic dehydrogenase - sign the consent form.

Exclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

- qt interval prolongation - imminence of orotracheal intubation (intubation prediction in the first 4 hours after randomization) - women who are pregnant or breastfeeding - corticosteroid allergy or intolerance - chronic corticosteroid users (prednisone equivalent > 10 mg daily) - patients diagnosed with cancer with increased bleeding potential - patients in hemodialysis - history of peptic ulcer - herpes zoster infection - history or active treatment of tuberculosis - systemic fungal infection - use of anticoagulation due to previous pathology - glaucoma - live virus vaccine up to 90 days before randomization - known coagulopathy or thrombocytopenia (<40,000/mm3) or hypofibrinogenemia (< 50 mg/dl) - recent bleeding - another limiting comorbidity for administering the therapies provided for in this protocol in in researcher's opinion

Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

4

Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

D'Or Institute for Research and Education

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

Brazil

Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Severe disease at enrollment

Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

6: Severe disease at enrollment

Total sample size
Last imported at : Aug. 12, 2021, 4 p.m.
Source : ClinicalTrials.gov

0

primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Rate of invasive mechanical ventilation

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 3

Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": " ", "treatment_id": 1337, "treatment_name": "Unfractioned heparin", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": " ", "treatment_id": 798, "treatment_name": "Methylprednisolone", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": " ", "treatment_id": 2230, "treatment_name": "Methylprednisolone+unfractioned heparin", "treatment_type": "Corticosteroids+coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": " ", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]