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STATIN THERAPY AND COVID-19 INFECTION (STACOV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04407273
Recruitment Status : Active, not recruiting
First Posted : May 29, 2020
Last Update Posted : September 17, 2020
Sponsor:
Information provided by (Responsible Party):
LUIS MASANA, MD, Institut Investigacio Sanitaria Pere Virgili

Brief Summary:
Considering that simvastatin, and probably statins in general, interfere with SARS-cov-2 cellular uptake and some inflammatory pathways activated by the virus, those patients on statin therapy should be less vulnerable to infection and their clinical course and prognosis should be better than that in individuals not on statin therapy.

Condition or disease Intervention/treatment
COVID Statin Cardiovascular Diseases Drug: observational

Detailed Description:

Statins reduce intracellular cholesterol synthesis by interfering with the limiting enzyme HMGCoA reductase. A lower intracellular cholesterol concentration leads to activation of the transcription factor SREBP 2 upregulating LDL receptor synthesis. In general, intracellular cholesterol homeostasis achieves a new physiological equilibrium at lower cholesterol concentrations. Moreover, the effect of cholesterol pathway inhibition has also an effect on farnesyl and geranyl molecules formation influencing protein prenylation leading to changes on inflammation and immunomodulation in vitro.

Changes in intracellular cholesterol alter cell membrane composition, particularly the structures referred to cholesterol rafts that accommodate a huge number of cell surface proteins as receptors. Theoretically, alterations in cholesterol rafts could derange the function of some receptors Some preliminary studies on cell models have suggested that statins could interfere the activity of some membrane viral receptors blunting its entry to cell (Berraondo P et al CIMA nonpublished data). SARS-cov-2 goes into cells through the Angiotensin Converser Enzyme 2 (ACE2) which is located in the surface of several cells including lung cells. It has been suggested that simvastatin could have a role in SARS-cov-2 infection by blocking the virus entry to cell. However, atorvastatin has been shown to increase ACE2 expression in animal models. Moreover, intracellular cholesterol content seems to influence the virus uptake.

Severe SARS-cov-2 infection is mediated by an inflammatory storm resulting in a deep tissue injury, endothelial damage, prothrombotic state and multiorgan failure. As mentioned above, statins also have some potent anti-inflammatory effects as modulating TNF, the NFkB transcription factor or blocking some members of the Tool Like Receptor family as TLR4-9 and its downstream cofactor MYD88. This anti-inflammatory effect has been implicated in a better prognosis of some diseases as HBV or HCV chronic infection, limiting the progression of hepatic damage to chronic liver disease or hepatocarcinoma. The impact of statin use on influenza epidemics has been repetitively assessed but contradictory or non-conclusive results have been obtained. The combination of statins and angiotensin receptor blockers have shown an important protective effect on other epidemics as Ebola, probably to their action on endothelium protection. A protective effect of statins on pulmonary hypertension development in a primate HIV model has also been reported. Although, in general all these pleiotropic effects of statins have been shown in vitro and its clinical impact is not clear, a clinical assay to test the efficacy of simvastatin on SARS-cov-2 is going on. Recently an observational study including more than 8000 patients infected by Sars-Cov-2 showed the protective effect of being on statins or ACE inhibitors. Taken into account its widespread use and putative effects on viral entry, inflammation, immune mechanisms and endothelial function, the use of standard therapies as statins have been postulated to target the host response to new virus pandemics.

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Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: STATIN THERAPY AND COVID-19 INFECTION (STACOV PROJECT)
Actual Study Start Date : May 14, 2020
Actual Primary Completion Date : August 20, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
with statins
Covid-19 infected patients with statins
Drug: observational
observational study

without statins
Covid-19 infected patients without statins
Drug: observational
observational study




Primary Outcome Measures :
  1. SARS-cov-2 scale of severity (9 steps) in Covid-19 infected patients with statin therapy [ Time Frame: at the time of admission ]
    Assess the difference in the WHO SARS-cov-2 scale of severity (9 steps) achieved by Covid-19 infected patients, admitted in the hospital, with and without background statin therapy comparable in age and gender distribution



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population

This is a retrospective observational multicentre study based on clinical records review.

The following centres will take part in the study:

LIPIDCAS Group:

  • Hospital Universitari Sant Joan
  • Hospital Universitari Joan XXIII
  • Hospital Sant Pau i Santa Tecla
  • Hospital Verge de la Cinta
  • Pius Hospital de Valls
  • Hospital del Vendrell

Other centres from the LIPID AND ARTERIOSCLEROSIS UNITS NET (XULA) from Catalonia.

Criteria

Inclusion Criteria:

  • Patients ≥ 18 years old with a PCR or immunological confirmation of Covid-19 infection, admitted in the hospital for at least 24 hours, will be included.

Exclusion Criteria:

  • Patients < 18 years old.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04407273


Locations
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Spain
Facultat de Medicina i Ciències de la Salut de Reus
Reus, Tarragona, Spain, 43201
Sponsors and Collaborators
Institut Investigacio Sanitaria Pere Virgili
Investigators
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Principal Investigator: Lluís Masana, Dr IISPV
  Study Documents (Full-Text)

Documents provided by LUIS MASANA, MD, Institut Investigacio Sanitaria Pere Virgili:
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Responsible Party: LUIS MASANA, MD, Dr, Institut Investigacio Sanitaria Pere Virgili
ClinicalTrials.gov Identifier: NCT04407273    
Other Study ID Numbers: 106/2020
First Posted: May 29, 2020    Key Record Dates
Last Update Posted: September 17, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiovascular Diseases