COVID-STAT: Atorvastatin for Reduction of 28-day Mortality in COVID-19: RCT
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Atorvastatin All patients will be randomized to receive atorvastatin 40 mg once daily orally for a maximum of 28 days. All patients will receive the standard of care according to recent local hospital protocol. Antiviral treatment will be allowed and will be reported. Administration in unconscious or ventilated patients: The patients will receive the drug (divided into 4 quadrants) through a nasogastric tube. |
Drug: Atorvastatin 40 Mg Oral Tablet
Patients will receive Atorvastatin 40 mg orally within 24 hrs after hospital admission after evaluation of the clinical and laboratory inclusion criteria.
Other Names:
|
| Placebo Comparator: Control All patients will be randomized to receive the placebo once daily orally for a maximum of 28 days. All patients will receive the standard of care according to recent local hospital protocol. Antiviral treatment will be allowed and will be reported. Administration in unconscious or ventilated patients: The patients will receive the drug through a nasogastric tube. Placebo will resemble the original drug as regards the drug package, the tablet color, consistency, and size. |
Other: Placebo
A formulary similar to the drug tablets and labels but without the active ingredients (Atorvastatin).
|
Outcome Measures
Primary Outcome Measures
- mortality [28 days after randomization]
all-cause mortality
- mortality [6 months after randomization]
all-cause mortality
Secondary Outcome Measures
- 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.
- serious adverse effects [28 days after start of the drug]
any event that leads to discontinuation of the drug
- Intensive Care length of stay [28 days or primary hospital stay]
duration in days
- 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
Other Outcome Measures
- C-Reactive Protein [on days 3, 7, 14, and 28 after randomization/ if still hospitalized]
as inflammatory marker
- Sequential Organ Failure Assessment scale [on days 3, 7, 14, and 28 after randomization/ if still hospitalized]
SOFA scale
- COVID Disease progression score [on days 3, 7, 14, and 28 after randomization/ if still hospitalized]
according to the January 2021 WHO update
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mansoura University Hospitals | Mansoura | Aldakahlia | Egypt | 35516 |
Sponsors and Collaborators
- Mansoura University
Investigators
- Study Director: Moataz M Emara, MD, EDAIC, Mansoura University - Faculty of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- R.21.04.1300.R1