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Column | Value |
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Trial registration number | RBR-7jrxqm |
Full text link
Last imported at : Jan. 8, 2021, 12:45 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
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First author
Last imported at : Dec. 15, 2020, 2:47 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
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Contact
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
rodrigo.pimentel@ebserh.gov.br |
Registration date
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
2020-07-10 |
Recruitment status
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Recruiting |
Study design
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
RCT |
Allocation
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Randomized |
Design
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Parallel |
Masking
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Blind label |
Center
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
unclear |
Study aim
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Treatment |
Inclusion criteria
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Patients with the following criteria will be included: adults aged between 18 and 65 years, diagnosed with Covid-19 by molecular examination (RT-PCR), with pervious gastrointestinal tract, using oral diet and who are not on mechanical ventilation or requiring icu admission. |
Exclusion criteria
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Pregnant patients, who have undergone the use of artificial nutrition in the 15 days prior to inclusion in this study, patients allergic to any components of the diets used, with severe hyperglycemia(greater than 180mg/dl) or hypertriglyceridemia (greater than 400mg/dl), with previous gastrointestinal diseases (surgical resections, malabsorption syndromes, inflammatory bowel diseases, persistent paralytic ileus, upper gastrointestinal bleeding or severe acute pancreatitis), with neutropenia-defined immunosuppression states, myelodysplastic syndromes, congenital immunodeficiency, or Acquired Immunodeficiency Syndrome (AIDS), immunosuppressive therapies in the last 03 months, systemic chemotherapy in the last 03 months, autologous bone marrow transplantation in the last year, halogenic bone marrow transplantation in the last 02 years, or existence of graft versus host disease (DEVH), with advanced chronic diseases (Child-Pugh stage C, grade IV heart failure (NYHA), chronic functional stage lung failure IV, terminal degenerative neurological processes, neoplasms in remission or progression over treatment), with processes with short life expectancy including end-stage chronic kidney disease, with acute processes that determine small survival as shock of any etiology with multiple organ dysfunction refractory to therapy in the first 48h or post-resuscitation severe neurological damage within 72 hours will be excluded |
Number of arms
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
2 |
Funding
Last imported at : Dec. 15, 2020, 2:47 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Universidade do Estado da Bahia |
Inclusion age min
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
18 |
Inclusion age max
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
65 |
Countries
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Brazil |
Type of patients
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Mild/moderate disease at enrollment |
Severity scale
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
2: Mild/moderate disease at enrollment |
Total sample size
Last imported at : Dec. 15, 2020, 2:47 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
0 |
primary outcome
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
We will observe the reduction of serum levels of inflammatory markers (C-Reactive Protein; IL6 and TNF-) in patients infected with Covid-19 through serum biochemical dosage from the finding of at least 30% difference between groups. |
Notes
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
|
Phase
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Not reported |
Arms
Last imported at : Dec. 15, 2020, 2:47 p.m. Source : International Clinical Trials Registry Platform (ICTRP) |
[{"arm_notes": "", "treatment_id": 636, "treatment_name": "Immunonutrient-enriched supplement", "treatment_type": "Nutrition", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}] |