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

NCT04952350 | Unknown Phase 3 DMC

• 1 other identifier: R.21.04.1300.R1
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; SARS-CoV2 Infection; COVID-19 Pneumonia

Keywords

Atorvastatin; randomized clinical trial

Outcome Measures

Primary Outcomes (2)

• mortality

  all-cause mortality

  28 days after randomization

• mortality

  all-cause mortality

  6 months after randomization

Secondary Outcomes (8)

• incidence of invasive mechanical ventilation (IMV)

  28 days or primary hospital stay

• duration of invasive mechanical ventilation (IMV)

  28 days or primary hospital stay

• Time to clinical improvement

  28 days or primary hospital stay

• serious adverse effects

  28 days after start of the drug

• Intensive Care length of stay

  28 days or primary hospital stay

Other Outcomes (3)

• C-Reactive Protein

  on days 3, 7, 14, and 28 after randomization/ if still hospitalized

• Sequential Organ Failure Assessment scale

  on days 3, 7, 14, and 28 after randomization/ if still hospitalized

• COVID Disease progression score

  on days 3, 7, 14, and 28 after randomization/ if still hospitalized

Study Arms (2)

Atorvastatin

ACTIVE COMPARATOR

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

Control

PLACEBO COMPARATOR

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

Interventions

Atorvastatin 40 Mg Oral Tablet DRUG

Patients will receive Atorvastatin 40 mg orally within 24 hrs after hospital admission after evaluation of the clinical and laboratory inclusion criteria.

Also known as: 134523-00-5, ATORVASTATIN CALCIUM, Lipitor

Atorvastatin

Placebo OTHER

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University Hospitals

Al Mansurah, Aldakahlia, 35516, Egypt

Location

Related Publications (2)

• Eltahan NH, Elsawy NH, Abdelaaty KM, Elhamaky AS, Hassan AH, Emara MM. Atorvastatin for reduction of 28-day mortality in severe and critical COVID-19 patients: a randomized controlled trial. Respir Res. 2024 Feb 22;25(1):97. doi: 10.1186/s12931-024-02732-2.

  PMID: 38389078 DERIVED

• 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.

  PMID: 35941669 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Atorvastatin; Tablets

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Moataz M Emara, MD, EDAIC

  Mansoura University - Faculty of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: July 7, 2021
• Study Start: August 14, 2021
• Primary Completion: November 1, 2021
• Study Completion: April 1, 2022
• Last Updated: October 25, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: will be updtaed shortly
• Access Criteria: will be updated shortly

Locations

EG (1)