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

Primary Purpose

Covid19, SARS-CoV2 Infection, COVID-19 Pneumonia

Status

Unknown status

Phase

Phase 3

Locations

Egypt

Study Type

Interventional

Intervention

Atorvastatin 40 Mg Oral Tablet

Placebo

About this trial

This is an interventional treatment trial for Covid19 focused on measuring Atorvastatin, randomized clinical trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Mansoura University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Atorvastatin

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

mortality

all-cause mortality

mortality

all-cause mortality

Secondary Outcome Measures

incidence of invasive mechanical ventilation (IMV)

incidence

duration of invasive mechanical ventilation (IMV)

duration in days

Time to clinical improvement

2 points reduction in the WHO disease ordinal progression scale or discharge, whatever happens first.

serious adverse effects

any event that leads to discontinuation of the drug

Intensive Care length of stay

duration in days

acute kidney injury

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

dead or alive

Hospital length of stay

Length of hospital stay in days

Full Information

NCT ID

NCT04952350

First Posted

July 1, 2021

Last Updated

October 22, 2021

Sponsor

Mansoura University

1. Study Identification

Unique Protocol Identification Number

NCT04952350

Brief Title

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

Acronym

COVID-STAT

Official Title

Atorvastatin in Hospitalized COVID-19 Patients: A Randomized, Double-blinded, Placebo-Controlled, Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Unknown status

Study Start Date

August 14, 2021 (Actual)

Primary Completion Date

November 2021 (Anticipated)

Study Completion Date

April 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid19, SARS-CoV2 Infection, COVID-19 Pneumonia

Keywords

Atorvastatin, randomized clinical trial

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes 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.

Allocation

Randomized

Enrollment

220 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Atorvastatin

Arm Type

Active Comparator

Arm Description

Arm Title

Control

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Atorvastatin 40 Mg Oral Tablet

Other Intervention Name(s)

134523-00-5, ATORVASTATIN CALCIUM, Lipitor

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

mortality

Description

all-cause mortality

Time Frame

28 days after randomization

Title

mortality

Description

all-cause mortality

Time Frame

6 months after randomization

Secondary Outcome Measure Information:

Title

incidence of invasive mechanical ventilation (IMV)

Description

incidence

Time Frame

28 days or primary hospital stay

Title

duration of invasive mechanical ventilation (IMV)

Description

duration in days

Time Frame

28 days or primary hospital stay

Title

Time to clinical improvement

Description

2 points reduction in the WHO disease ordinal progression scale or discharge, whatever happens first.

Time Frame

28 days or primary hospital stay

Title

serious adverse effects

Description

any event that leads to discontinuation of the drug

Time Frame

28 days after start of the drug

Title

Intensive Care length of stay

Description

duration in days

Time Frame

28 days or primary hospital stay

Title

acute kidney injury

Description

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.

Time Frame

28 days or primary hospital stay

Title

status at hospital discharge

Description

dead or alive

Time Frame

through study completion, an average of 9 months

Title

Hospital length of stay

Description

Length of hospital stay in days

Time Frame

through study completion, an average of 9 months

Other Pre-specified Outcome Measures:

Title

C-Reactive Protein

Description

as inflammatory marker

Time Frame

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

Title

Sequential Organ Failure Assessment scale

Description

SOFA scale

Time Frame

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

Title

COVID Disease progression score

Description

according to the January 2021 WHO update

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Moataz M Emara, MD, EDAIC

Organizational Affiliation

Mansoura University - Faculty of Medicine

Official's Role

Study Director

Facility Information:

Facility Name

Mansoura University Hospitals

City

Mansoura

State/Province

Aldakahlia

ZIP/Postal Code

35516

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

We will make the anonymous individual data available at reasonable request after publication. Patient confidentiality will be kept safe.

IPD Sharing Time Frame

will be updtaed shortly

IPD Sharing Access Criteria

will be updated shortly

Citations:

PubMed Identifier

35941669

Citation

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.

Results Reference

derived

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

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