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

NCT ID: NCT04952350

Last Updated: 2021-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-14

Study Completion Date

2022-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Covid19 SARS-CoV2 Infection COVID-19 Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
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.

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Atorvastatin 40 Mg Oral Tablet

Intervention Type DRUG

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

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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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.

Intervention Type DRUG

Placebo

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

Intervention Type OTHER

Other Intervention Names

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134523-00-5 ATORVASTATIN CALCIUM Lipitor

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Moataz M Emara, MD, EDAIC

Role: STUDY_DIRECTOR

Mansoura University - Faculty of Medicine

Locations

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Mansoura University Hospitals

Al Mansurah, Aldakahlia, Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type DERIVED
PMID: 38389078 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35941669 (View on PubMed)

Other Identifiers

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R.21.04.1300.R1

Identifier Type: -

Identifier Source: org_study_id