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

Covid19 Clinical Trial

— COVID-STAT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04952350
• Other study ID #: R.21.04.1300.R1
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: August 14, 2021
• Est. completion date: April 2022

Study information

• Verified date: October 2021
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 220
• Est. completion date: April 2022
• Est. primary completion date: November 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pneumonia
• Covid19
• SARS-CoV2 Infection

Intervention

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).

Locations

Country	Name	City	State
Egypt	Mansoura University Hospitals	Mansoura	Aldakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	C-Reactive Protein	as inflammatory marker	on days 3, 7, 14, and 28 after randomization/ if still hospitalized
Other	Sequential Organ Failure Assessment scale	SOFA scale	on days 3, 7, 14, and 28 after randomization/ if still hospitalized
Other	COVID Disease progression score	according to the January 2021 WHO update	on days 3, 7, 14, and 28 after randomization/ if still hospitalized
Primary	mortality	all-cause mortality	28 days after randomization
Primary	mortality	all-cause mortality	6 months after randomization
Secondary	incidence of invasive mechanical ventilation (IMV)	incidence	28 days or primary hospital stay
Secondary	duration of invasive mechanical ventilation (IMV)	duration in days	28 days or primary hospital stay
Secondary	Time to clinical improvement	2 points reduction in the WHO disease ordinal progression scale or discharge, whatever happens first.	28 days or primary hospital stay
Secondary	serious adverse effects	any event that leads to discontinuation of the drug	28 days after start of the drug
Secondary	Intensive Care length of stay	duration in days	28 days or primary hospital stay
Secondary	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.	28 days or primary hospital stay
Secondary	status at hospital discharge	dead or alive	through study completion, an average of 9 months
Secondary	Hospital length of stay	Length of hospital stay in days	through study completion, an average of 9 months