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Hydroxychloroquine in SARS-CoV-2 (COVID-19) Pneumonia Trial

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04382625
Recruitment Status : Not yet recruiting
First Posted : May 11, 2020
Last Update Posted : May 11, 2020
Sponsor:
Collaborator:
Washington State University
Information provided by (Responsible Party):
Kootenai Health

Brief Summary:
Novel coronavirus SARS(Severe Acute Respiratory Syndrome)-CoV-2 was first identified during the outbreak in Wuhan, China in December 2019 with the now resulting pandemic. Aggressive supportive care is the mainstay of treatment currently and rescue with lung protective mechanical ventilation is essential for survival in patients with severe acute respiratory distress syndrome. Despite supportive care, mortality is significant in hospitalized patients in the U.S., especially among patients > 65 years of age. Pharmacologic treatments to decrease disease severity are urgently needed. Hydroxychloroquine is currently widely used for treatment of autoimmune disease including systemic lupus erythematosus and rheumatoid arthritis, and it has been used to prevent and treat malaria. In vitro and in vivo antiviral activity towards SARS-CoV-2 has been reported. Since hydroxychloroquine has been used for decades its properties as a drug are well known. The investigators propose a pragmatic trial of hydroxychloroquine in moderately ill hospitalized adults with SARS-CoV-2 pneumonia with the hypothesis that hydroxychloroquine reduces severity of acute lung injury caused by SARS-CoV-2 infection.

Condition or disease Intervention/treatment Phase
SARS-CoV-2 Pneumonia COVID-19 Drug: Hydroxychloroquine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single-center pragmatic randomized open-label trial of hydroxychloroquine + usual care in hospitalized adults with confirmed SARS-CoV-2 infection and acute hypoxia compared to usual care.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hydroxychloroquine in SARS-CoV-2 (COVID-19) Pneumonia Trial
Estimated Study Start Date : May 2020
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Experimental: Hydroxychloroquine (HCQ)
Initial dose: HCQ 400mg x 2 (800mg) then 200mg by mouth, three times per day (600mg/24hr period) starting 8 hours after the initial dose for a total of 14 doses over 5 days Plus Usual Care (See below for full description)
Drug: Hydroxychloroquine
Hydroxychloroquine is currently widely used for treatment of autoimmune disease including systemic lupus erythematosus and rheumatoid arthritis, and it has been used to prevent and treat malaria.
Other Name: Plaquenil

No Intervention: Usual Care
The care of hospitalized patients with covid-19 is evolving with hospital guidelines arising across the U.S. with several commonalities. Patients receive clinical assessment, chest x-ray, covid-19 testing, basic labs (WBC, CMP), and additional labs based on protocol or clinical judgment (ABG, CRP, LDH), antibiotics for possible bacterial pneumonia, acetaminophen for fever, supplemental O2, and consideration for mechanical ventilation. Early intubation over escalating noninvasive support. Low tidal volume ventilation and prone positioning are lung protective strategies used in critically ill covid-19 patients that are based on management of acute respiratory distress syndrome generally. Conservative fluid replacement is used to avoid worsening oxygenation.



Primary Outcome Measures :
  1. Change from Baseline Oxygenation on Day 1 to Day 5 [ Time Frame: Day 1 of treatment to day 5 of treatment ]
    paO2

  2. Change from Baseline Oxygenation at Day 5 [ Time Frame: Day 1 of treatment to day 5 of treatment ]
    FIO2


Secondary Outcome Measures :
  1. Intensive Care length of stay [ Time Frame: Day 0 to Day 28 ]
    Length in hours

  2. Required Mechanical Ventilation [ Time Frame: Day 0 to Day 28 ]
    Length in hours

  3. Required Oxygen supplementation [ Time Frame: Day 0 to Day 28 ]
    Length in hours

  4. Hospitalization length of Stay [ Time Frame: Day 0 to Day 28 ]
    Length in hours

  5. Mortality [ Time Frame: Day 0 to Day 28 ]
    Date of Death

  6. Cardiac Arrhythmia - Polymorphic Ventricular Tachycardia [ Time Frame: Day 0 to Day 28 ]
    Cardiologist Diagnostic Documentation

  7. Cardiac Arrhythmia - Ventricular Tachycardia [ Time Frame: Day 0 to Day 28 ]
    Cardiologist Diagnostic Documentation

  8. Cardiac Arrhythmia - Lengthening QTc [ Time Frame: Day 0 to Day 28 ]
    Cardiologist Diagnostic Documentation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age > 18 years of age
  2. SARS-CoV-2 positive per FDA approved RT-PCR (reverse transcription-polymerase chain reaction)
  3. Acute hypoxia (O2 sat < 90 % or paO2 < 60 on room air), or above baseline chronic O2 requirement
  4. Inpatient admission

Exclusion Criteria:

  1. Requires supplemental O2 >10 litres per minute or mechanical ventilation on admission
  2. Pregnancy
  3. AST/ALT > 5 times the upper limit normal
  4. Baseline prolonged QT
  5. Child-Pugh Score B or greater
  6. ESRD(end-stage renal disease) requiring dialysis
  7. Known allergy to medication component,
  8. History of severe G6PD (glucose-6-phosphate dehydrogenase)
  9. Myasthenia gravis
  10. Porphyria
  11. Ongoing treatment for epilepsy
  12. Life expectancy < 6 months,
  13. Patient lacks capacity to provide consent and does not have a surrogate decision maker.
  14. Retinal Disease

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): NCT04382625


Contacts
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Contact: Sandra Albritton, MN,RN 208-625-4223 salbritton@kh.org
Contact: Shamela Barnett 208-625-5273 sbarnett@kh.org

Locations
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United States, Idaho
Kootenai Health
Coeur d'Alene, Idaho, United States, 83814
Contact: Sandra Albritton, MN,RN    208-625-4223    salbritton@kh.org   
Contact: Shamela Barnett    208-625-5273    sbarnett@kh.org   
Sponsors and Collaborators
Kootenai Health
Washington State University
Investigators
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Principal Investigator: Sean Cook, D.O. Kootenai Health
Principal Investigator: Jeanette Berg, MD, PhD Kootenai Health
Principal Investigator: Sterling McPherson, PhD Washington State University
Principal Investigator: John Roll, PhD Washington State University
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Responsible Party: Kootenai Health
ClinicalTrials.gov Identifier: NCT04382625    
Other Study ID Numbers: 18244
First Posted: May 11, 2020    Key Record Dates
Last Update Posted: May 11, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Kootenai Health:
SARS-CoV-2
Pneumonia
Hydroxychloroquine
COVID-19
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents