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| Column | Value |
|---|---|
| Trial registration number | NCT04952350 |
|
Full text link
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : Oct. 26, 2021, 11 a.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : Oct. 26, 2021, 11 a.m. Source : ClinicalTrials.gov |
mm.emara@mans.edu.eg |
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Registration date
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
2021-07-07 |
|
Recruitment status
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
Not recruiting |
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Study design
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
|
Study aim
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
inclusion criteria: - we will include adult patients (≥18 years old) with severe and critical covid19 admitted to the covid19 mansoura university isolation hospital. we will include patients who are pcr-confirmed, clinically or radiologically diagnosed with covid19. cases are defined as severe or critical according to the who definition (19); where critical cases have ards, or sepsis, septic shock or pulmonary embolism, acute coronary syndrome, or acute stroke, while severe cases have the clinical signs of severe pneumonia and spo2 <90% on room air, or rr <30 breaths/min without any critical criteria. |
|
Exclusion criteria
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
- chronic statin use, serum creatine kinase (sr ck) > 5 times the upper limit of normal (uln), serum transaminases > 5 times uln, acute hepatic failure, chronic liver disease (child-pugh classification c), history of rhabdomyolysis or myopathies, severe renal impairment not receiving renal replacement therapy (estimated cr cl< 30 ml\min ), pregnant and lactating women, patients who are expected to die within 48 hours, or patients on chronic colchicine, cyclosporines, or ritonavir. |
|
Number of arms
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
2 |
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Funding
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
Mansoura University |
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Inclusion age min
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
100 |
|
Countries
Last imported at : Oct. 26, 2021, 11 a.m. Source : ClinicalTrials.gov |
Egypt |
|
Type of patients
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
Severe/critical disease at enrollment |
|
Severity scale
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
7: Severe/critical disease at enrollment |
|
Total sample size
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
220 |
|
primary outcome
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
mortality;mortality |
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Notes
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
Phase 3 |
|
Arms
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 137, "treatment_name": "Atorvastatin", "treatment_type": "Metabolic agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |