Covid19, SARS-CoV2 Infection, COVID-19 Pneumonia
Conditions
Keywords
Atorvastatin, randomized clinical trial
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.
Interventions
Patients will receive Atorvastatin 40 mg orally within 24 hrs after hospital admission after evaluation of the clinical and laboratory inclusion criteria.
OTHERPlacebo
A formulary similar to the drug tablets and labels but without the active ingredients (Atorvastatin).
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Patients, caregivers, data collectors, and data analysts will be blinded for the study group. The Delta Pharma company (Egypt) will provide the atorvastatin and a similar placebo. The company will not participate in any step of the study including participant recruitment, data collection, data analysis, or results reporting. The company will prepare a similar package of drug and placebo (labeled as A and B). Even the pharmacist involved in treatment allocation will not know what is the treatment group, just A or B. For emergency unmasking, one of the directors of the COVID19 research council, who will not participate in the study, will know the true labels and the randomization table.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| mortality | 28 days after randomization | all-cause mortality |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| serious adverse effects | 28 days after start of the drug | any event that leads to discontinuation of the drug |
| acute kidney injury | 28 days or primary hospital stay | 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. |
| status at hospital discharge | through study completion, an average of 9 months | dead or alive |
| Hospital length of stay | through study completion, an average of 9 months | Length of hospital stay in days |
| incidence of invasive mechanical ventilation (IMV) | 28 days or primary hospital stay | incidence |
| duration of invasive mechanical ventilation (IMV) | 28 days or primary hospital stay | duration in days |
| Time to clinical improvement | 28 days or primary hospital stay | 2 points reduction in the WHO disease ordinal progression scale or discharge, whatever happens first. |
| Intensive Care length of stay | 28 days or primary hospital stay | duration in days |
Other
| Measure | Time frame | Description |
|---|---|---|
| COVID Disease progression score | on days 3, 7, 14, and 28 after randomization/ if still hospitalized | according to the January 2021 WHO update |
| Sequential Organ Failure Assessment scale | on days 3, 7, 14, and 28 after randomization/ if still hospitalized | SOFA scale |
| C-Reactive Protein | on days 3, 7, 14, and 28 after randomization/ if still hospitalized | as inflammatory marker |
Countries
Egypt
Outcome results
None listed