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Efficacy of Chloroquine or Hydroxychloroquine in Treating Pneumonia Caused by SARS-Cov-2 - COVID-19

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ClinicalTrials.gov Identifier: NCT04420247
Recruitment Status : Recruiting
First Posted : June 9, 2020
Last Update Posted : June 17, 2020
Sponsor:
Information provided by (Responsible Party):
ALVARO REA-NETO, MD, Centro de Estudos e Pesquisa em Emergencias Medicas e Terapia Intensiva

Brief Summary:
Facing the challenge of finding an efficient treatment for COVID-19, the viral pneumonia caused by the Coronavirus SARS-Cov-2, this study intended to test if Chloroquine or Hydroxychloroquine, two drugs with strong in-vitro antiviral role proven by numerous studies and with a well defined safety profile established, for efficacy in treating COVID-19 and improving an ordinal primary outcome composed by a 9-levels scale, which was recomended by the World Health Organization.

Condition or disease Intervention/treatment Phase
COVID COVID-19 SARS-CoV 2 Coronavirus Corona Virus Infection Drug: Chloroquine Drug: Hydroxychloroquine Other: standard care Phase 3

Detailed Description:

This is a Phase 3, Adaptive, Multicentric Randomized Controled Trial of efficacy to test the effect of either Chloroquine or Hydroxychloroquine for 5 days in the recomended dose standardized by brazilian Ministry of Health.

Patients were randomized using stratified randomization by hospital and severity at the moment of randomization (stipulated by use of mechanical ventilation or not) into two arms: Intervention and Control. Intervention group recieved a loading dose of 900mg of Chloroquine or 800mg of Hydroxycloroquine in the first day, followed by 450mg of chloroquine of 400mg of hydroxychloroquine. Primary and secondary outcomes were evaluated on the 3rd, 5th, 7th, 10th, 14th, 28th day after randomization.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Two arms - Intervention and Control Intervention received unblinded treatment with Chloroquine or Hyroxycloroquine for 5 days, as well as standard treatment available and recomended by the Brazilian Guidelines for COVID-19.

Control group received just the standard treatment available and recomended by the Brazilian Guidelines for COVID-19.

Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicentric Pragmatic Randomized Controled Trial to Evaluate the Efficacy Chloroquine or Hydroxychloroquine for Five Days in Treating Pneumonia Caused by SARS-Cov-2 - COVID-19
Actual Study Start Date : April 16, 2020
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : August 31, 2020


Arm Intervention/treatment
Experimental: Intervention

Treatment with either Chloroquine or Hydroxychloroquine according to what was available in the hospital:

Chloroquine - 900mg on the first day, followed by 450mg in the next 4 days. Hydroxychloroquine - 800mg on the first day, followed by 450mg in the next 4 days.

+

Standard treatment available and recomended by the Brazilian Guidelines for COVID-19.

Drug: Chloroquine
5 days of treatment with Chloroquine + Standard Care

Drug: Hydroxychloroquine
5 days of treatment with Hydroxychloroquine + Standard Care

Active Comparator: Control
Standard treatment available and recomended by the Brazilian Guidelines for COVID-19.
Other: standard care
Standard Care according to Brazilian Guidelines for treating COVID-19




Primary Outcome Measures :
  1. World Health Organization (WHO) 9-levels scale (from 0-8) [ Time Frame: Day14 ]
    9-levels scale recomended by WHO for studies related to treating COVID-19

  2. WHO 9-levels scale (from 0-8) [ Time Frame: Day 28 ]
    9-levels scale recomended by WHO for studies related to treating COVID-19, with lower scores meaning better outcomes (0 means at home with no symptoms and


Secondary Outcome Measures :
  1. Mortality [ Time Frame: Day 28 ]
    28day mortality

  2. Ventilation free days [ Time Frame: Day 28. ]
    Days without need of Mechanical Ventilation

  3. Duration of mechanical ventilation [ Time Frame: Day 28. ]
  4. National Early Warning Score (NEWS) [ Time Frame: Day 7 ]
    Trigger system aligned to the scale of clinical risk. Minimum score is 0 (better outcome) and maximum score is 20 (worse outcome). The higher the score, the higher the risk.

  5. National Early Warning Score (NEWS) [ Time Frame: Day 14 ]
    Trigger system aligned to the scale of clinical risk. Minimum score is 0 (better outcome) and maximum score is 20 (worse outcome). The higher the score, the higher the risk.

  6. National Early Warning Score (NEWS) [ Time Frame: Day 28 ]
    Trigger system aligned to the scale of clinical risk. Minimum score is 0 (better outcome) and maximum score is 20 (worse outcome). The higher the score, the higher the risk.

  7. ICU Lenght of Stay [ Time Frame: Day 28. ]
  8. Hospital Lenght of Stay [ Time Frame: Day 28. ]
  9. Acute Kidney Disease incidence [ Time Frame: Day 28. ]
  10. Percentage of patients needing Dialysis [ Time Frame: Day 28. ]
  11. Mean of C Reactive Protein Levels [ Time Frame: Days 3. ]
  12. Mean of C Reactive Protein Levels [ Time Frame: Days 5. ]
  13. Mean of C Reactive Protein Levels [ Time Frame: Days 7. ]
  14. Mean of C Reactive Protein Levels [ Time Frame: Days 10. ]
  15. Mean of C Reactive Protein Levels [ Time Frame: Days 14. ]
  16. Mean of Leucocytes Levels [ Time Frame: Days 3. ]
  17. Mean of Leucocytes Levels [ Time Frame: Days 5. ]
  18. Mean of Leucocytes Levels [ Time Frame: Days 7. ]
  19. Mean of Leucocytes Levels [ Time Frame: Days 10. ]
  20. Mean of Leucocytes Levels [ Time Frame: Days 14. ]
  21. Mean of Lymphocyte Levels [ Time Frame: Days 3. ]
  22. Mean of Lymphocyte Levels [ Time Frame: Days 5. ]
  23. Mean of Lymphocyte Levels [ Time Frame: Days 7. ]
  24. Mean of Lymphocyte Levels [ Time Frame: Days 10. ]
  25. Mean of Lymphocyte Levels [ Time Frame: Days 14. ]


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:

  • Adult Males and non-pregnant females that accept and sign the informed consent.
  • Hospitalized with COVID-19 suspection that has collected the confirmatory test
  • To have at least one of thes symptoms: Fever, coughing, throat ache or runny nose.
  • To have at least one of these findings: radiological findings that indicates COVID-10 (bilatareal ground grass images); O2 saturation lower than 94% without supplementation and crackles in lung auscultation; Need of O2 supplementation; Need of Mechanical Ventilation.
  • Female patients must also agree to use efficient counterceptive methods during the evaluation period.

Exclusion Criteria:

  • Patients with psoriasis or other exfoliative disease, porphyria, epilepsy, myasthenia gravis, advanced liver failure or glucose-6-phosphate dehydrogenase deficiency.
  • ALT / AST> 5 times the upper limit of normal.
  • Severe chronic kidney disease in stage 4 or requiring dialysis (ie, eGFR <30).
  • Pregnancy or breastfeeding.
  • Early transfer to another hospital that is not a study site within 72 hours.
  • Severe heart disease and / or a history of cardiac arrhythmia.
  • Allergy to Chloroquine and / or Hydroxychloroquine.

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): NCT04420247


Locations
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Brazil
Centro de Estudos e Pesquisa em Emergencias Clinicas e Terapia Intensiva Recruiting
Curitiba, Parana, Brazil, 82530200
Contact: ALVARO REA-NETO, MD    +5541999952200    reaneto@gmail.com   
Contact: Marcos Vinicius O Queiroga, MD    +5541991949958    marcosqueirogaresearch@gmail.com   
Sub-Investigator: Mirella Cristine Oliveira, MD         
Sub-Investigator: MARCOS VINICIUS O QUEIROGA, MD         
Sub-Investigator: RAFAELLA STRADIOTTO BERNADELLI, PHYSIOTHERAPIST         
Sponsors and Collaborators
Centro de Estudos e Pesquisa em Emergencias Medicas e Terapia Intensiva
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Responsible Party: ALVARO REA-NETO, MD, Director of the Reseach Center, Centro de Estudos e Pesquisa em Emergencias Medicas e Terapia Intensiva
ClinicalTrials.gov Identifier: NCT04420247    
Other Study ID Numbers: CLOROTRIAL
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: June 17, 2020
Last Verified: June 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
Keywords provided by ALVARO REA-NETO, MD, Centro de Estudos e Pesquisa em Emergencias Medicas e Terapia Intensiva:
VIRAL PNEUMONIA
CORONAVIRUS
COVID-19
COVID
SARS-COV-2
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Hydroxychloroquine
Chloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents
Amebicides