Clinical trial NCT04952350: Atorvastatin for Reduction of 28-day Mortality in COVID-19: RCT
Official title: Atorvastatin in Hospitalized COVID-19 Patients: A Randomized, Double-blinded, Placebo-Controlled, Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Covid19
SARS-CoV2 Infection
COVID-19 Pneumonia
Keywords: Atorvastatin
randomized clinical trial
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2021-07-07
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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:

* 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.

Primary outcomes:
measure: mortality
timeFrame: 28 days after randomization
measure: mortality
timeFrame: 6 months after randomization
Secondary outcomes:
measure: incidence of invasive mechanical ventilation (IMV)
timeFrame: 28 days or primary hospital stay
measure: duration of invasive mechanical ventilation (IMV)
timeFrame: 28 days or primary hospital stay
measure: Time to clinical improvement
timeFrame: 28 days or primary hospital stay
measure: serious adverse effects
timeFrame: 28 days after start of the drug
measure: Intensive Care length of stay
timeFrame: 28 days or primary hospital stay
measure: acute kidney injury
timeFrame: 28 days or primary hospital stay
measure: status at hospital discharge
timeFrame: through study completion, an average of 9 months
measure: Hospital length of stay
timeFrame: through study completion, an average of 9 months
Other outcomes:
measure: C-Reactive Protein
timeFrame: on days 3, 7, 14, and 28 after randomization/ if still hospitalized
measure: Sequential Organ Failure Assessment scale
timeFrame: on days 3, 7, 14, and 28 after randomization/ if still hospitalized
measure: COVID Disease progression score
timeFrame: on days 3, 7, 14, and 28 after randomization/ if still hospitalized
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University Hospitals
state: Aldakahlia
Study officials:
affiliation: Mansoura University - Faculty of Medicine
name: Moataz M Emara, MD, EDAIC
role: STUDY_DIRECTOR
References:
citation: Emara MM, Elsawy NH, Abdelaaty KM, Elhamaky AS, Eltahan NH. Atorvastatin for reduction of 28-day mortality in hospitalized COVID-19 patients: study protocol for a randomized, double-blinded, placebo-controlled, clinical trial. Trials. 2022 Aug 8;23(1):636. doi: 10.1186/s13063-022-06619-9.