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

Phase 3

• Conditions: Covid19; SARS-CoV2 Infection; COVID-19 Pneumonia
• Interventions: Drug: Atorvastatin 40 Mg Oral Tablet; Other: Placebo

• Registration Number: NCT04952350
• Lead Sponsor: Mansoura University

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2021-07-01
• Study First Submitted QC: 2021-07-02
• Study First Posted: 2021-07-07
• Study Start: 2021-08-14
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-22
• Last Update Posted: 2021-10-25
• Primary Completion: 2021-11
• Study Completion: 2022-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 220

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atorvastatin	Atorvastatin 40 Mg Oral Tablet	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.
Control	Placebo	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.

Primary Outcome Measures

Name	Time	Method
mortality	6 months after randomization	all-cause mortality

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Mansoura University Hospitals; 🇪🇬 Mansoura, Aldakahlia, Egypt