This randomized placebo-controlled double-blinded clinical trial aims to test the efficacy of administering atorvastatin 40 mg to hospitalized COVID-19 patients for 28 days on the all-cause 28-day mortality.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
220
Patients will receive Atorvastatin 40 mg orally within 24 hrs after hospital admission after evaluation of the clinical and laboratory inclusion criteria.
A formulary similar to the drug tablets and labels but without the active ingredients (Atorvastatin).
Mansoura University Hospitals
Al Mansurah, Aldakahlia, Egypt
mortality
all-cause mortality
Time frame: 28 days after randomization
mortality
all-cause mortality
Time frame: 6 months after randomization
incidence of invasive mechanical ventilation (IMV)
incidence
Time frame: 28 days or primary hospital stay
duration of invasive mechanical ventilation (IMV)
duration in days
Time frame: 28 days or primary hospital stay
Time to clinical improvement
2 points reduction in the WHO disease ordinal progression scale or discharge, whatever happens first.
Time frame: 28 days or primary hospital stay
serious adverse effects
any event that leads to discontinuation of the drug
Time frame: 28 days after start of the drug
Intensive Care length of stay
duration in days
Time frame: 28 days or primary hospital stay
acute kidney injury
Increase in Scr by \>/ 0.3 mg/ dl in 48 hr or Increase in Scr by \>/ 50% in 7 days or Oliguria for \>/ 6 hours.
Time frame: 28 days or primary hospital stay
status at hospital discharge
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dead or alive
Time frame: through study completion, an average of 9 months
Hospital length of stay
Length of hospital stay in days
Time frame: through study completion, an average of 9 months