Cardiovascular Effects of COVID-19
A Single-center Registry and Embedded Interventional Study of the Effects of COVID-19 With and Without Treatment With AT-001 on Cardiac Structure and Function in Patients Hospitalized for Management of COVID-19 Infection
Cardiometabolic disease may confer increased risk of adverse outcomes in COVID-19 patients by activation of the aldose reductase pathway, a trigger of the inflammatory cascade. The study team hypothesizes that aldose reductase inhibition with AT-001 (caficrestat) might represent a novel therapeutic approach to reduce inflammation and risk of adverse outcomes in diabetic patients with COVID-19.
An open-label pilot study to assess safety, tolerability and efficacy of AT-001 in hospitalized COVID-19 patients with history of diabetes mellitus and heart disease will be conducted. Eligible participants will be treated with AT-001 1500 mg twice daily for up to 14 days. Safety, tolerability, survival and length of hospital stay data were compared with matched controls from a contemporaneous registry of COVID-19 patients.
Studieoversikt
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
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New York
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New York, New York, Forente stater, 10016
- NYU Langone Health
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria
Registry Study: In order to be eligible to participate in the registry study, an individual must meet all of the following criteria:
- Age ≥18 years of age
- Hospitalized at one of the participating NYULH locations
- Confirmed COVID-19 infection
Interventional Study: In order to be eligible to participate in the registry study, and individual must meet all of the inclusion criteria of the registry study plus the following criteria:
- Hospitalized at NYU Tisch
- History of diabetes mellitus or blood glucose measurement >126 mg/dl AND EITHER
- History of hypertension and/or ischemic heart disease and/or heart failure OR
- Other co-morbid condition that in the opinion of the PI increases risk of heart or lung injury related to the aldose reductase pathway
Exclusion Criteria
Registry Study: An individual who meets any of the following criteria will be excluded from participation in the registry study:
- Persons who have opted out of research participation at NYU
- Pregnancy
Interventional study: An individual who meets any of the following criteria will be excluded from participation in the interventional study:
- Persons who have opted out of research participation at NYU
- Pregnancy
- Women of childbearing potential
- Breast-feeding women
- Participation in another investigational drug protocol within previous 30 days
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Interventional Patients: AT-001
AT-001 1500 mg (3 capsules) were administered by mouth twice daily for up to 14 days
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Investigational novel Aldose Reductase Inhibitor (ARI) Product: AT-001 500mg capsule for oral administration Dosage: 1,500mg (3X500mg capsules) twice daily Mode of Administration: Oral Up to 14 days per discretion of the investigators and treatment team
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Ingen inngripen: Control Match Group 1
Matched control from a contemporaneous de-identified registry of hospitalized patients with clinical COVID-19 diagnosis at the same institution was selected.
The first matching approach selected all subjects with diabetes mellitus and hypertension, and available data to match participants who received AT-001 for gender, age group (in bins of 5 years), weight, and C-reactive protein (CRP) value at the time of hospital admission.
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Ingen inngripen: Control Match Group 2
Matched control from a contemporaneous de-identified registry of hospitalized patients with clinical COVID-19 diagnosis at the same institution was selected.
The second matching approach selected all subjects in the registry with diabetes mellitus and available data to match participants who received AT-001 for gender, age group (in bings of 5 years), and weight (+/- 0.5 kgs).
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Hospital Length of Stay (LOS)
Tidsramme: Day 45
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Data collection from medical chart review
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Day 45
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Percentage of Participants Who Died
Tidsramme: Day 45
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Data collection from medical chart review
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Day 45
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Stuart Katz, MD, NYU Langone Health
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 20-00416
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
Tilgangskriterier for IPD-deling
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
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