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Dexamethasone and Oxygen Support Strategies in ICU Patients With Covid-19 Pneumonia (COVIDICUS)

6. februar 2021 opdateret af: Assistance Publique - Hôpitaux de Paris

Dexamethasone and Oxygen Support Strategies in ICU Patients With Covid-19 pneumonia_COVIDICUS

The main manifestation of COVID-19 is acute hypoxemic respiratory failure (AHRF). In patients with AHRF, the need for invasive mechanical ventilation is associated with high mortality.

Two hypotheses will be tested in this study. The first hypothesis is the benefit of corticosteroid therapy on severe COVID-19 infection admitted in ICU in terms of survival.

The second hypothesis is that, in the subset of patients free of mechanical ventilation at admission, either Continuous Positive Airway Pressure (CPAP) or High-Flow Nasal Oxygen (HFNO) allows to reduce intubation rate safely during COVID-19 related acute hypoxemic respiratory failure.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The main manifestation of COVID-19 is acute hypoxemic respiratory failure (AHRF). In patients with AHRF, the need for invasive mechanical ventilation is associated with high mortality.

Two hypotheses will be tested in this study. The first hypothesis is the benefit of corticosteroid therapy on severe COVID-19 infection admitted in ICU in terms of survival.

The second hypothesis is that, in the subset of patients free of mechanical ventilation at admission, either Continuous Positive Airway Pressure (CPAP) or High-Flow Nasal Oxygen (HFNO) allows to reduce intubation rate safely during COVID-19 related acute hypoxemic respiratory failure.

The main objective is to assess the impact of dexamethasone on overall mortality at day-60 after randomization in patients admitted in ICU for severe COVID-19 infection.

In non mechanical ventilation (MV) patients, the additional objective is to assess whether oxygen support based on either HFNO or CPAP modality in COVID-19 related AHRF reduces the need for mechanical ventilation at day-28.

An ancillary study CACAO (COVIDICUS air contamination) will be performed in 4 centers aiming at assessing the environmental contamination by SARS-CoV-2 according to the oxygen support modality. Additional funding will be searched for these analyses (submitted for ANR call).

A metanalysis on individual data will be performed using patients enrolled in the 3 PHRC flash exploring the activity of corticosteroids.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

550

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Frankrig
      • Paris, Frankrig, 75018
        • Hôpital Bichat - APHP

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Age ≥ 18 years
  2. Admitted to ICU within 48 hours
  3. Confirmed or highly suspected COVID-19 infection
  4. Acute hypoxemic respiratory failure (PaO2 <70 mmHg or SpO2<90% on room air or tachypnea>30/min or labored breathing or respiratory distress; need for oxygen flow >=6L/min)
  5. Any treatment intended to treat the SARS-CoV-2 infection in the absence of contraindications (either as a compassionate use or in the context of a clinical trial, i.e remdesivir, lopinavir/ritonavir, favipiravir, hydroxychloroquine and any other new drug with potential activity).

Non-inclusion Criteria:

  1. Moribund status
  2. Pregnancy or breastfeeding
  3. Long term corticotherapy at a dose of 0.5mg/kg/j or higher
  4. Active and untreated bacterial, fungal or parasitic infection
  5. Not Written informed consent from the patient or a legal representative if appropriate . If absence a legal representative the patient may be included in emergency procedure
  6. hypersensitivity to dexamethasone or to any of the excipients
  7. Not Affiliation to the French social security

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Faktoriel opgave
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Standard oxygen 1
Standard oxygen and placebo of Dexamethasone
Medicin: placebo
Box of 10 NaCl 0,9% , solution for injection in ampoule of 5mL. Each allocated box contains complete treatment from D1 to D10 for one patient.
Procedure: conventional oxygen
The oxygen flow will be adjusted to maintain an oxygen saturation level of 92% or more, as measured by means of pulse oximetry (SpO2)
Eksperimentel: Standard oxygen 2
Standard oxygen and Dexamethasone
Procedure: conventional oxygen
The oxygen flow will be adjusted to maintain an oxygen saturation level of 92% or more, as measured by means of pulse oximetry (SpO2)
Medicin: Dexamethasone injection
Box of 10 DEXAMETHASONE 20 mg / 5 ml, solution for injection in ampoule of 5mL. Each allocated box contains complete treatment from D1 to D10 for one patient.
Andre navne:
  • eksperimentel behandling
Eksperimentel: CPAP 1
CPAP and placebo of Dexamethasone
Medicin: placebo
Box of 10 NaCl 0,9% , solution for injection in ampoule of 5mL. Each allocated box contains complete treatment from D1 to D10 for one patient.
Procedure: CPAP
Patients assigned to the CPAP plus oxygen group will receive periods of CPAP in addition to the standard treatment.The oxygen flow will be adjusted to maintain an oxygen saturation level of 92% or more, as measured by means of pulse oximetry (SpO2)
Eksperimentel: CPAP 2
CPAP and Dexamethasone
Medicin: Dexamethasone injection
Box of 10 DEXAMETHASONE 20 mg / 5 ml, solution for injection in ampoule of 5mL. Each allocated box contains complete treatment from D1 to D10 for one patient.
Andre navne:
  • eksperimentel behandling
Procedure: CPAP
Patients assigned to the CPAP plus oxygen group will receive periods of CPAP in addition to the standard treatment.The oxygen flow will be adjusted to maintain an oxygen saturation level of 92% or more, as measured by means of pulse oximetry (SpO2)
Eksperimentel: HFNO 1
HFNO and placebo of Dexamethasone
Medicin: placebo
Box of 10 NaCl 0,9% , solution for injection in ampoule of 5mL. Each allocated box contains complete treatment from D1 to D10 for one patient.
Procedure: HFNO
TIn the high-flow-nasal cannula group, oxygen will be delivered through a heated humidifier (Airvo-2, Fisher and Paykel Healthcare) and applied continuously through large-bore binasal prongs, with a gas flow rate of 30 liters per minute and adjusted based on the clinical response. FiO2 will be adjusted for the target SpO2
Eksperimentel: HFNO 2
HFNO and Dexamethasone
Medicin: Dexamethasone injection
Box of 10 DEXAMETHASONE 20 mg / 5 ml, solution for injection in ampoule of 5mL. Each allocated box contains complete treatment from D1 to D10 for one patient.
Andre navne:
  • eksperimentel behandling
Procedure: HFNO
TIn the high-flow-nasal cannula group, oxygen will be delivered through a heated humidifier (Airvo-2, Fisher and Paykel Healthcare) and applied continuously through large-bore binasal prongs, with a gas flow rate of 30 liters per minute and adjusted based on the clinical response. FiO2 will be adjusted for the target SpO2
Placebo komparator: mechanically ventilated 1
placebo
Medicin: placebo
Box of 10 NaCl 0,9% , solution for injection in ampoule of 5mL. Each allocated box contains complete treatment from D1 to D10 for one patient.
Procedure: mechanical ventilation
The oxygen flow will be adjusted to maintain an oxygen saturation level of 92% or more, as measured by means of pulse oximetry (SpO2)
Eksperimentel: mechanically ventilated 2
Dexamethasone
Medicin: Dexamethasone injection
Box of 10 DEXAMETHASONE 20 mg / 5 ml, solution for injection in ampoule of 5mL. Each allocated box contains complete treatment from D1 to D10 for one patient.
Andre navne:
  • eksperimentel behandling
Procedure: mechanical ventilation
The oxygen flow will be adjusted to maintain an oxygen saturation level of 92% or more, as measured by means of pulse oximetry (SpO2)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The time-to-death from all causes
Tidsramme: day-60
The time-to-death from all causes within the first 60 days after randomization.
day-60
The time to need for mechanical ventilation (MV)
Tidsramme: day-28.
the time to need for mechanical ventilation (MV), as defined by any of the 3 criteria for intubation within the first 28 days after randomization.
day-28.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The viral load in the respiratory tract
Tidsramme: day-10
The cycle threshold for SARS-CoV-2 PCR at baseline, day 7+/-1 and day 10 +/- in samples of the same origin (preferably subglottic i.e. bronchoalveolar lavage or tracheal aspiration, otherwise nasopharyngeal swab)
day-10
Number of patient with at least one episode of healthcare-associated infections
Tidsramme: day-28
Proportion of patients with at least one episode of any healthcare-associated infection between randomization and D28
day-28
Number of days alive without mechanical ventilation
Tidsramme: day-28
To compare the exposition to mechanical ventilation
day-28
Measure of SOFA score
Tidsramme: day-1 to day 3, day 7, day 10, day 21, day 28
Changes in SOFA (Sepsis-related Organ Failure Assessment) score. (min = 0 for normal status max = 24 for worse status)
day-1 to day 3, day 7, day 10, day 21, day 28
Number of days alive without renal replacement therapy
Tidsramme: day-28
to compare the exposition to renal replacement therapy
day-28
Lengths of ICU-stay
Tidsramme: day-60
To compare the lengths of ICU
day-60
Lengths of hospital-stay
Tidsramme: day-60
To compare the lengths of hospital-stay
day-60
Number of patients with severe hypoxemia,
Tidsramme: day 60
Proportion of patients with severe hypoxemia, which is defined as an oxygen saturation of less than 80% during the same interval during the interval between induction and 2 minutes after tracheal intubation
day 60
Proportion of patients with cardiac arrest within 1 hour after intubation
Tidsramme: day 60
Proportion of patients with cardiac arrest within 1 hour after intubation
day 60
Overall survival
Tidsramme: day 60
To compare Overall survival after randomization
day 60

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Assistance Publique - Hôpitaux de Paris

Efterforskere

  • Ledende efterforsker: Jean François TIMSIT, Pr, Assistance Publique - Hôpitaux de Paris

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

10. april 2020

Primær færdiggørelse (Forventet)

31. december 2021

Studieafslutning (Forventet)

31. december 2021

Datoer for studieregistrering

Først indsendt

9. april 2020

Først indsendt, der opfyldte QC-kriterier

13. april 2020

Først opslået (Faktiske)

14. april 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. februar 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. februar 2021

Sidst verificeret

1. februar 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • APHP200388
  • 2020-001457-43 (EudraCT nummer)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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