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| Column | Value |
|---|---|
| Trial registration number | NCT04957940 |
|
Full text link
Last imported at : July 14, 2021, 6 a.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : Sept. 29, 2021, 8:30 a.m. Source : ClinicalTrials.gov |
|
|
Contact
Last imported at : Sept. 29, 2021, 8:30 a.m. Source : ClinicalTrials.gov |
omarmakram347@yahoo.com |
|
Registration date
Last imported at : July 14, 2021, 6 a.m. Source : ClinicalTrials.gov |
2021-07-12 |
|
Recruitment status
Last imported at : Sept. 29, 2021, 8:30 a.m. Source : ClinicalTrials.gov |
Completed |
|
Study design
Last imported at : July 14, 2021, 6 a.m. Source : ClinicalTrials.gov |
RCT |
|
Allocation
Last imported at : July 14, 2021, 6 a.m. Source : ClinicalTrials.gov |
Randomized |
|
Design
Last imported at : July 14, 2021, 6 a.m. Source : ClinicalTrials.gov |
Parallel |
|
Masking
Last imported at : July 14, 2021, 6 a.m. Source : ClinicalTrials.gov |
Blind label |
|
Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
|
Study aim
Last imported at : July 14, 2021, 6 a.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : Aug. 31, 2021, 8:30 p.m. Source : ClinicalTrials.gov |
inclusion criteria: - patients are with diagnosis of moderate cases of covid-19 (a person who may have lower respiratory illness, such as pneumonia. however, their blood oxygen levels remain ≥94%) - requiring only supplemental oxygen in form of simple nasal cannula or venturi mask oxygen admitted in the intermediate care attached to our icu with good enteral nutrition. |
|
Exclusion criteria
Last imported at : July 14, 2021, 6 a.m. Source : ClinicalTrials.gov |
- hypersensitivity (peanut,eggs and soya bean) - uncontrolled hyperlipidemia - severe primary blood coagulation diseases - acute pancreatitis - acute thromboembolic diseases - liver failure (bilirubin >40 mmol/l, alanine aminotransferase >100 u/l and aspartate aminotransferase >100 u/l) - rifle (risk, injury, failure, loss of kidney function and end-stage kidney disease) stage iii and iv renal failure - pregnancy or lactation - severe neutropenia (<500 cells/mm3) |
|
Number of arms
Last imported at : July 14, 2021, 6 a.m. Source : ClinicalTrials.gov |
2 |
|
Funding
Last imported at : July 14, 2021, 6 a.m. Source : ClinicalTrials.gov |
Assiut University |
|
Inclusion age min
Last imported at : July 14, 2021, 6 a.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : July 14, 2021, 6 a.m. Source : ClinicalTrials.gov |
100 |
|
Countries
Last imported at : July 14, 2021, 6 a.m. Source : ClinicalTrials.gov |
Egypt |
|
Type of patients
Last imported at : July 14, 2021, 6 a.m. Source : ClinicalTrials.gov |
Moderate disease at enrollment |
|
Severity scale
Last imported at : July 14, 2021, 6 a.m. Source : ClinicalTrials.gov |
3: Moderate disease at enrollment |
|
Total sample size
Last imported at : Sept. 29, 2021, 8:30 a.m. Source : ClinicalTrials.gov |
74 |
|
primary outcome
Last imported at : July 14, 2021, 6 a.m. Source : ClinicalTrials.gov |
Shift of patients to ICU |
|
Notes
Last imported at : July 14, 2021, 6 a.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : July 14, 2021, 6 a.m. Source : ClinicalTrials.gov |
Phase 3 |
|
Arms
Last imported at : July 14, 2021, 6 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 1209, "treatment_name": "Smof lipid", "treatment_type": "Nutrition", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |