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

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: NCT04322396
Recruitment Status : Terminated (Recommended by the DSMB)
First Posted : March 26, 2020
Results First Posted : June 28, 2021
Last Update Posted : June 29, 2021
Sponsor:
Information provided by (Responsible Party):
Chronic Obstructive Pulmonary Disease Trial Network, Denmark

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

Condition or disease Intervention/treatment Phase
Virus Diseases Infection Viral Corona Virus Infection Drug: Azithromycin Drug: Hydroxychloroquine Drug: Placebo oral tablet Phase 2

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 117 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 6, 2020
Actual Primary Completion Date : February 2, 2021
Actual Study Completion Date : February 2, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: 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

 Drug: Placebo oral tablet
Placebo Azithromycin

Drug: Placebo oral tablet
Placebo Hydroxychloroquine
Active Comparator: 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

 Drug: Azithromycin
Azithromycin

Drug: Hydroxychloroquine
Hydroxychloroquine


Outcome Measures
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Primary Outcome Measures :
  1. Number of Days Alive and Discharged From Hospital Within 14 Days [ Time Frame: 14 days ]

Secondary Outcome Measures :
  1. Categorization of Hospitalization Status [ Time Frame: 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".


  2. Length of Stay in ICU [ Time Frame: 14 days ]
    Length of stay in intensive care unit.

  3. Number of Participants on Non-invasive Ventilation (NIV) During Hospitalization [ Time Frame: 14 days ]
  4. Mortality [ Time Frame: 30 days ]
  5. Length of Hospitalization [ Time Frame: 14 days ]
  6. Days Alive and Discharged From Hospital [ Time Frame: 30 days ]
  7. Mortality [ Time Frame: 90 days ]
  8. Mortality [ Time Frame: 365 days ]
  9. Number of Readmissions (All Causes) [ Time Frame: 30 days ]
  10. Number of Days Using Non-invasive Ventilation (NIV) [ Time Frame: 14 days ]
    Number of days using non-invasive ventilation (NIV) if on NIV during hospitalization.

  11. Change in Patient's Oxygen Partial Pressure [ Time Frame: 4 days ]
    PaO2 measured in arterial puncture at baseline and 4 days.

  12. Change in Patient's Carbondioxide Partial Pressure [ Time Frame: 4 days ]
    PaCO2 measured in arterial puncture at baseline and 4 days.

  13. Change of pH in Blood [ Time Frame: 4 days ]
    pH measured in arterial puncture at baseline and 4 days.

  14. Time for no Oxygen Supplement (or Regular Oxygen Supplement "LTOT") [ Time Frame: 14 days ]
    Time for no oxygen supplement (or regular oxygen supplement "LTOT") if on oxygen during admission.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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): NCT04322396


Locations
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Denmark
Aalborg Sygehus
Aalborg, Denmark
Bispebjerg Hospital
Copenhagen, Denmark
Herlev-Gentofte Hospital
Copenhagen, Denmark
Hvidovre Hospital
Copenhagen, Denmark
Nordsjællands Hospital
Hillerød, Denmark
Odense Universitetshospital
Odense, Denmark
Roskilde Sygehus
Roskilde, Denmark
Slagelse Sygehus
Slagelse, Denmark
Sponsors and Collaborators
Chronic Obstructive Pulmonary Disease Trial Network, Denmark
  Study Documents (Full-Text)

Documents provided by Chronic Obstructive Pulmonary Disease Trial Network, Denmark:
Study Protocol  [PDF] April 16, 2020
Statistical Analysis Plan  [PDF] May 19, 2020

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Chronic Obstructive Pulmonary Disease Trial Network, Denmark
ClinicalTrials.gov Identifier: NCT04322396    
Other Study ID Numbers: KronLungesyg_COVID_19_protokol
First Posted: March 26, 2020    Key Record Dates
Results First Posted: June 28, 2021
Last Update Posted: June 29, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Virus Diseases
Coronavirus Infections
Disease Attributes
Pathologic Processes
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Azithromycin
 Hydroxychloroquine
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents