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

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ClinicalTrials.gov Identifier: NCT04322396
Recruitment Status : Recruiting
First Posted : March 26, 2020
Last Update Posted : May 11, 2020
Sponsor:
Information provided by (Responsible Party):
Chronic Obstructive Pulmonary Disease Trial Network, Denmark

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 226 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Proactive Prophylaxis 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
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : March 31, 2021


Arm Intervention/treatment
Placebo Comparator: Control
This arm will receive standard care and placebo in 15 days.
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.
Drug: Azithromycin
Azithromycin

Drug: Hydroxychloroquine
Hydroxychloroquine




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 becategorized 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. Admitted to intensive care unit, if admitted to ICU then length of stay [ Time Frame: 14 days ]
  3. Have used 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 ]
  11. Change in patient's oxygen partial pressure [ Time Frame: 4 days ]
    Delta PaO2 measured in arterial puncture

  12. Change in patient's carbondioxid partial pressure [ Time Frame: 4 days ]
    Delta PaCO2 measured in arterial puncture

  13. Level of pH in blood [ Time Frame: 4 days ]
    pH measured in arterial puncture

  14. Time for no oxygen supplement (or regular oxygen supplement "LTOT") [ Time Frame: 14 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
  • Signes 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
  • Breatfeeding
  • 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/arrhytmias or prolonged QTc interval
  • Myasthenia Gravis
  • Uses Digoxin
  • Glucose-6-phosphate dehydrogenase defiency
  • 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

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


Contacts
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Contact: Jens-Ulrik Stæhr Jensen, MD, PhD 004528938168 jens.ulrik.jensen@regionh.dk

Locations
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Denmark
Aalborg Sygehus Recruiting
Aalborg, Denmark
Contact: Ulla Weinreich         
Bispebjerg Hospital Recruiting
Copenhagen, Denmark
Contact: Therese Lapperre         
Herlev-Gentofte Hospital Recruiting
Copenhagen, Denmark
Contact: Jens-Ulrik Jensen, MD, PhD         
Hvidovre Hospital Recruiting
Copenhagen, Denmark
Contact: Charlotte Ulrik         
Nordsjællands Hospital Recruiting
Hillerød, Denmark
Contact: Andrea Browatzki         
Odense Universitetshospital Recruiting
Odense, Denmark
Contact: Christian Laursen         
Roskilde Sygehus Recruiting
Roskilde, Denmark
Contact: Christian Meyer         
Slagelse Sygehus Recruiting
Slagelse, Denmark
Contact: Uffe Bødtger         
Sponsors and Collaborators
Chronic Obstructive Pulmonary Disease Trial Network, Denmark
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
Last Update Posted: May 11, 2020
Last Verified: May 2020

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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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Infection
Communicable Diseases
Coronavirus Infections
Severe Acute Respiratory Syndrome
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Azithromycin
Hydroxychloroquine
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents