Atorvastatin for Reduction of 28-day Mortality in COVID-19: RCT

Overview

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.

Full Title of Study: “Atorvastatin in Hospitalized COVID-19 Patients: A Randomized, Double-blinded, Placebo-Controlled, Clinical Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: November 2021

Interventions

  • 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: Placebo
    • A formulary similar to the drug tablets and labels but without the active ingredients (Atorvastatin).

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • mortality
    • Time Frame: 28 days after randomization
    • all-cause mortality
  • mortality
    • Time Frame: 6 months after randomization
    • all-cause mortality

Secondary Measures

  • incidence of invasive mechanical ventilation (IMV)
    • Time Frame: 28 days or primary hospital stay
    • incidence
  • duration of invasive mechanical ventilation (IMV)
    • Time Frame: 28 days or primary hospital stay
    • duration in days
  • Time to clinical improvement
    • Time Frame: 28 days or primary hospital stay
    • 2 points reduction in the WHO disease ordinal progression scale or discharge, whatever happens first.
  • serious adverse effects
    • Time Frame: 28 days after start of the drug
    • any event that leads to discontinuation of the drug
  • Intensive Care length of stay
    • Time Frame: 28 days or primary hospital stay
    • duration in days
  • acute kidney injury
    • Time Frame: 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
    • Time Frame: through study completion, an average of 9 months
    • dead or alive
  • Hospital length of stay
    • Time Frame: through study completion, an average of 9 months
    • Length of hospital stay in days

Participating in This Clinical Trial

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 mlmin ), pregnant and lactating women, patients who are expected to die within 48 hours, or patients on chronic colchicine, cyclosporines, or ritonavir.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mansoura University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Moataz M Emara, MD, EDAIC, Study Director, Mansoura University – Faculty of Medicine

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.