- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04605926
A Study to Evaluate the Efficacy and Safety of Itolizumab in Subjects Hospitalized With COVID-19 (EQUINOX)
25. januar 2021 oppdatert av: Equillium
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Itolizumab in Subjects Hospitalized With COVID-19
This is a randomized controlled trial to evaluate the efficacy and safety of itolizumab in subjects hospitalized with COVID-19.
Studieoversikt
Status
Tilbaketrukket
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This study will randomize up to 800 subjects in a 1:1 ratio; itolizumab vs. placebo.
Subjects will receive either itolizumab or placebo administered intravenously on Day 1 and Day 8 with follow-up to Day 90.
Two interim analyses of futility are planned.
The first will take place when approximately 20% of the subjects have been evaluated for the primary endpoint, and the second will take place when approximately 50% of the subjects have been evaluated for the primary endpoint.
Studietype
Intervensjonell
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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-
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Medellín, Colombia
- Inv Site CO01
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Is willing and able to, or has a legally acceptable representative who is willing and able to, provide informed consent to participate and to cooperate with all aspects of the protocol.
- Is male or female, age ≥18 years
- Is hospitalized with COVID-19 pneumonia with a diagnosis of SARS-CoV-2 infection confirmed by reverse transcriptase polymerase chain reaction (RT-PCR) or equivalent local test within 14 days of randomization.
- Has PaO2/FiO2 ratio of ≤200 (or equivalent SpO2/FiO2 ratio ~235 within 24 hours before randomization. This ratio may be adjusted based on altitude.
Exclusion Criteria:
- Has known severe allergic reactions to mAbs.
- Has active TB or known history of inadequately treated latent or active TB.
- Has any known active systemic or pulmonary bacterial, fungal, or viral (other than SARS-CoV-2) infection at the time of randomization.
- Has known active, uncontrolled hepatitis B or hepatitis C or severe liver function impairment from any etiology, as defined by Child-Pugh Class C.
- Has human immunodeficiency virus (HIV) with known CD4 counts <0.2 × 10^9/L.
- Has a history of clinically significant cardiac abnormality within 6 months prior to randomization, such as myocardial infarction or stroke, New York Heart Association class III or IV, or clinically significant abnormalities of electrocardiogram (ECG) or cardiac function.
- Has been on mechanical ventilation for longer than 48 hours during their first continuous episode since admission, is on their second or greater episode of mechanical ventilation at the time of randomization during the concurrent hospitalization, or has received extracorporeal membrane oxygenation (ECMO).
- Has a declining clinical status with an expected survival <3 days in the opinion of the Investigator.
- Has received any systemic immunomodulatory or immunosuppressant agents for any condition within 3 months prior to randomization. (Note: a stable, oral, low dose of corticosteroids [prednisone or equivalent ≤10 mg/day] for a chronic condition or any dose of systemic corticosteroids for current COVID-19 treatment are permitted. Local/topical treatments are also permitted.)
- Has received any biologic treatment for any acute (eg, COVID-19) or chronic conditions (eg, TNFα inhibitors, anti-IL17A, tocilizumab, anti-cytokines, etc.) within 3 months prior to randomization.
- Is participating in another clinical study of an investigational product and/or received an investigational product within 30 days or within 5 half-lives (whichever is longer) prior to randomization.
- Is pregnant or breastfeeding, or has a positive pregnancy serum or urine test during Screening.
- Does not agree to use contraception in the event of sexual activity for 130 days (+90 days for male subjects) after the last dose of study drug if a female of childbearing potential or a male with a partner of childbearing potential. Note: this criterion does not apply to subjects in same-sex relationships.
Has inadequate hematologic function during Screening defined as follows:
- Absolute neutrophil count (ANC) <1.0 × 109/L.
- ALC <0.5 × 109/L.
- Requires renal dialysis, either acute or chronic, at the time of randomization.
- Has a medical, psychiatric, or other condition or circumstance that, in the opinion of the Investigator, could affect the subject's safety, the subject's participation in the study, or the reliability of the study data.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: EQ001
EQ001 administered in a blinded fashion by intravenous infusion on Day 1 and Day 8 for a total of 2 doses.
|
itolizumab [Bmab600]
Andre navn:
|
Placebo komparator: EQ001 Placebo
Placebo administered in a blinded fashion by intravenous infusion on Day 1 and Day 8 for a total of 2 doses.
|
EQ001 Placebo
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Proportion of subjects who have recovered at Day 28.
Tidsramme: Day 28
|
Proportion of subjects who have recovered at Day 28.
|
Day 28
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Proportion of subjects deceased or requiring mechanical ventilation at Day 28.
Tidsramme: Day 28
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Proportion of subjects deceased or requiring mechanical ventilation at Day 28.
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Day 28
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Proportion of subjects deceased at Day 28.
Tidsramme: Day 28
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Proportion of subjects deceased at Day 28.
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Day 28
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Incidence of treatment-emergent adverse events (TEAEs).
Tidsramme: Day 90
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Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE)
|
Day 90
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Time to maximum itolizumab serum concentration, Tmax
Tidsramme: Day 28
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Time to maximum itolizumab serum concentration, Tmax
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Day 28
|
Maximum itolizumab serum drug concentration, Cmax
Tidsramme: Day 28
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Maximum itolizumab serum drug concentration, Cmax
|
Day 28
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Total itolizumab exposure across time, AUC (from zero to last)
Tidsramme: Day 28
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Total itolizumab exposure across time, AUC (from zero to last)
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Day 28
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Inflammatory biomarkers
Tidsramme: Day 28
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Including but not limited to IL-1, IL-6, IL-17, TNF-α.
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Day 28
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Pharmacodynamic markers
Tidsramme: Day 28
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sCD6, sALCAM
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Day 28
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Studieleder: Maple Fung, MD, Equillium
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Forventet)
1. november 2020
Primær fullføring (Forventet)
1. april 2021
Studiet fullført (Forventet)
1. juni 2021
Datoer for studieregistrering
Først innsendt
21. oktober 2020
Først innsendt som oppfylte QC-kriteriene
27. oktober 2020
Først lagt ut (Faktiske)
28. oktober 2020
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
27. januar 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
25. januar 2021
Sist bekreftet
1. januar 2021
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- EQ001-20-001
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Nei
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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