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Proactive Protection With Azithromycin and hydroxyChloroquine in Hospitalized Patients With COVID-19 (ProPAC-COVID)

28. juni 2021 opdateret af: Chronic Obstructive Pulmonary Disease Trial Network, Denmark

Proactive Protection With Azithromycin and Hydroxychloroquine in Hospitalized Patients With COVID: A Randomized, Placebo-controlled Double-blinded Trial Evaluating Treatment With Azithromycin and Hydroxychloroquine to Patients With COVID-19

This study explores whether patients acutely hospitalized may have shorter hospitalization and fewer admittances at Intensive Care Units by treatment with azithromycin and hydroxychloroquine.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

In the ongoing coronavirus pandemic, COVID-19, that arose in Wuhan China, there is still sparse data in the course, risk of various complications, and in particular how patients who are hospitalized are best treated to ensure high survival and short hospitalization. Despite the rapid spread of the disease globally, there is no solid data yet to recommend any specific treatments, which is why symptomatic, organ supportive therapy including respiratory therapy in acute pulmonary failure is recommended. There has been reported a high incidence of bacterial super-infections in patients with COVID-19. Patients with COVID-19 also have a higher risk of dying because of septic shock. Thus, there is an urgent need for treatment that can improve the patient's chance of the shortest hospitalization possible, and treatment that can lower the risk of secondary infection and death.

This is a randomized, placebo-controlled, double-blinded multi-center trial evaluating the effect of azithromycin and hydroxychloroquine treatment in patients with COVID-19 during hospitalization. The aim of the study is to investigate whether the treatment can shorten hospitalization, reduce the risk of non-invasive ventilation, admittance to Intensive Care Units and death.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

117

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Danmark
      • Aalborg, Danmark
        • Aalborg Sygehus
      • Copenhagen, Danmark
        • Bispebjerg Hospital
      • Copenhagen, Danmark
        • Hvidovre Hospital
      • Copenhagen, Danmark
        • Herlev-Gentofte Hospital
      • Hillerød, Danmark
        • Nordsjællands Hospital
      • Odense, Danmark
        • Odense Universitetshospital
      • Roskilde, Danmark
        • Roskilde Sygehus
      • Slagelse, Danmark
        • Slagelse Sygehus

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

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Patient admitted to a Danish emergency department, lung medical department or medical department
  • Age >18 years
  • Hospitalized <48 hours
  • Positive COVID-19 test/diagnosis during the hospitalization
  • Signs informed consent

Exclusion Criteria:

  • If the patient uses > 5 LO2/min at time of recruitment
  • Known intolerance/allergy to azithromycin or hydroxychloroquine or hypersensitivity to quinine or 4-aminoquinolinderivates
  • Pregnancy
  • Breastfeeding
  • Neurogenic hearing loss
  • Psoriasis
  • Retinopathy
  • Maculopathy
  • Changes in vision field
  • Severe liver disease other than amoebiases
  • Severe gastrointestinal, neurological or haematological disorders
  • eGFR < 45 ml/min/1.73m2
  • Clinically significant cardiac conduction disorders/arrhythmias or prolonged QTc interval
  • Myasthenia Gravis
  • Uses Digoxin
  • Glucose-6-phosphate dehydrogenase deficiency
  • Porphyria
  • Hypoglycemia at any time since hospitalization
  • Severe mental illness which significantly impedes cooperation
  • Severe linguistic problems that significantly impedes cooperation
  • Treatment with sickle alkaloids

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: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Control

This arm will receive standard care and placebo in 15 days.

Azithromycin placebo:

Day 1-3: 500 mg x 1 Day 4-15: 250 mg x 1

Hydroxychloroquine placebo:

Day 1-15: 200 mg x 2
Medicin: Placebo oral tablet
Placebo Azithromycin
Medicin: Placebo oral tablet
Placebo Hydroxychloroquine
Aktiv komparator: Intervention

This arm will receive standard care and azithromycin and hydroxychloroquine in 15 days.

Azithromycin:

Day 1-3: 500 mg x 1 Day 4-15: 250 mg x 1

Hydroxychloroquine:

Day 1-15: 200 mg x 2
Medicin: Hydroxychloroquin
Hydroxychloroquin
Medicin: Azithromycin
Azithromycin

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Number of Days Alive and Discharged From Hospital Within 14 Days
Tidsramme: 14 days
14 days

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Dødelighed
Tidsramme: 30 dage
30 dage
Dødelighed
Tidsramme: 90 dage
90 dage
Dødelighed
Tidsramme: 365 dage
365 dage
Categorization of Hospitalization Status
Tidsramme: 14 days

The patient will be categorized into one of the following 8 categories depending on status of their hospitalization:

  1. Dead (yes/no)
  2. Hospitalized and receiving mechanical ventilation or ExtraCorporalMembraneOxygenation (ECMO) (yes/no)
  3. Hospitalized and receiving Non-invasive ventilation or "high-flow oxygen device" (yes/no)
  4. Hospitalized and given oxygen supplements different from (2) and (3) (yes/no)
  5. Hospitalized and without oxygen treatment, but receiving other treatment (both related to COVID-19 or other) (yes/no)
  6. Hospitalized for observation (yes/no)
  7. Discharged from hospital with restriction of activity level (yes/no)
  8. Discharged from hospital without any restrictions of activity level (yes/no)

Only one category can be "yes".
14 days
Length of Stay in ICU
Tidsramme: 14 days
Length of stay in intensive care unit.
14 days
Number of Participants on Non-invasive Ventilation (NIV) During Hospitalization
Tidsramme: 14 days
14 days
Length of Hospitalization
Tidsramme: 14 days
14 days
Days Alive and Discharged From Hospital
Tidsramme: 30 days
30 days
Number of Readmissions (All Causes)
Tidsramme: 30 days
30 days
Number of Days Using Non-invasive Ventilation (NIV)
Tidsramme: 14 days
Number of days using non-invasive ventilation (NIV) if on NIV during hospitalization.
14 days
Change in Patient's Oxygen Partial Pressure
Tidsramme: 4 days
PaO2 measured in arterial puncture at baseline and 4 days.
4 days
Change in Patient's Carbondioxide Partial Pressure
Tidsramme: 4 days
PaCO2 measured in arterial puncture at baseline and 4 days.
4 days
Change of pH in Blood
Tidsramme: 4 days
pH measured in arterial puncture at baseline and 4 days.
4 days
Time for no Oxygen Supplement (or Regular Oxygen Supplement "LTOT")
Tidsramme: 14 days
Time for no oxygen supplement (or regular oxygen supplement "LTOT") if on oxygen during admission.
14 days

Samarbejdspartnere og efterforskere

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

Sponsor

Chronic Obstructive Pulmonary Disease Trial Network, Denmark

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)

6. april 2020

Primær færdiggørelse (Faktiske)

2. februar 2021

Studieafslutning (Faktiske)

2. februar 2021

Datoer for studieregistrering

Først indsendt

23. marts 2020

Først indsendt, der opfyldte QC-kriterier

24. marts 2020

Først opslået (Faktiske)

26. marts 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. juni 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. juni 2021

Sidst verificeret

1. juni 2021

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • KronLungesyg_COVID_19_protokol

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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