Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| mortality | all-cause mortality | 28 days after randomization |
| mortality | all-cause mortality | 6 months after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of invasive mechanical ventilation (IMV) | incidence | 28 days or primary hospital stay |
| duration of invasive mechanical ventilation (IMV) | duration in days |
| Measure | Description | Time Frame |
|---|---|---|
| C-Reactive Protein | as inflammatory marker | on days 3, 7, 14, and 28 after randomization/ if still hospitalized |
| Sequential Organ Failure Assessment scale | SOFA scale |
Inclusion Criteria:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Moataz M Emara, MD, EDAIC | Mansoura University - Faculty of Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mansoura University Hospitals | Al Mansurah | Aldakahlia | 35516 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38389078 | Derived | 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. | |
| 35941669 | 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. |
Not provided
Not provided
We will make the anonymous individual data available at reasonable request after publication. Patient confidentiality will be kept safe.
Not provided
will be updtaed shortly
will be updated shortly
Not provided
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
|
| Placebo | Other | A formulary similar to the drug tablets and labels but without the active ingredients (Atorvastatin). |
|
| 28 days or primary hospital stay |
| 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 |
| serious adverse effects | any event that leads to discontinuation of the drug | 28 days after start of the drug |
| Intensive Care length of stay | duration in days | 28 days or primary hospital stay |
| 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 |
| status at hospital discharge | dead or alive | through study completion, an average of 9 months |
| Hospital length of stay | Length of hospital stay in days | through study completion, an average of 9 months |
| on days 3, 7, 14, and 28 after randomization/ if still hospitalized |
| COVID Disease progression score | according to the January 2021 WHO update | on days 3, 7, 14, and 28 after randomization/ if still hospitalized |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |