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Use of Hydroxychloroquine Alone or Associated for Inpatients With SARS-CoV2 Virus (COVID-19)

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: NCT04361461
Recruitment Status : Withdrawn (This study was canceled before enrollment due to a decision by the Sponsor)
First Posted : April 24, 2020
Last Update Posted : November 19, 2020
Sponsor:
Collaborator:
Federal University of São Paulo
Information provided by (Responsible Party):
Apsen Farmaceutica S.A.

Brief Summary:
The Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV2) has been identified in Wuhan, China, which causes severe pulmonary complications and flu syndrome, which has spread rapidly to all continents. Approximately 25% of hospitalized patients require treatment in intensive care units and 10% require mechanical ventilation. The diagnosis is made by the molecular polymerase chain reaction test. However, diagnostic tests are limited. The clinical care of the patient with COVID-19 is similar to that of patients with severe infectious respiratory complications, consisting of support and oxygen supplementation. Several medications have been tested as remdesivir, a pro-drug nucleoside, which acts by inhibiting viral RNA transcription, although a recently published study has shown no benefit. China recently approved the use of favipiravir, an antiviral used for influenza, as an experimental therapy for COVID-19. Hydroxychloroquine is a drug with great potential treatment, as it can inhibit the pH-dependent steps of replication of various viruses, with a potent effect on SARS-CoV infection and spread. In this way, the present study will evaluate the safety and efficacy of the hydroxychloroquine in patients with symptomatic SARS-Cov2.

Condition or disease Intervention/treatment Phase
Coronavirus Infections SARS-CoV 2 SARS (Severe Acute Respiratory Syndrome) Pulmonary Disease Drug: Hydroxychloroquine Sulfate Drug: Hydroxychloroquine Sulfate + Azythromycin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hydroxychloroquine or Hydroxychloroquine Associated With Azithromycin for Inpatients With Moderate or Severe Lung Disease Due to SARS-CoV-2 (COVID-19)
Estimated Study Start Date : April 30, 2020
Estimated Primary Completion Date : November 4, 2020
Estimated Study Completion Date : November 4, 2020


Arm Intervention/treatment
Experimental: Group 1
Hydroxychloroquine (400 mg)
Drug: Hydroxychloroquine Sulfate
400 mg orally, every 12 hours x 2 doses (loading dose) and then 400 mg, once daily, orally, for 10 days.
Other Name: Reuquinol®

Experimental: Group 2
Hydroxychloroquine (400 mg) + azithromycin (500 mg)
Drug: Hydroxychloroquine Sulfate + Azythromycin
400 mg, orally, every 12 hours x 2 doses (loading dose) and then 400 mg, once a day, orally, for 10 days associated with azithromycin, intravenously or orally, 500 mg / day, for 1 day and then 250mg / day for another 4 days.
Other Name: Reuquinol® + Azythromycin




Primary Outcome Measures :
  1. Individual response rate [ Time Frame: 14 days after randomization ]
    The individual response rate regarding the World Health Organization Ordinal Scale assessment from basal to 14th Day.


Secondary Outcome Measures :
  1. All-cause mortality [ Time Frame: 28 days after randomization ]
    All-cause mortality rates at Day 28th after randomization

  2. Duration of mechanical ventilation [ Time Frame: baseline ]
    Number of days that the patient was on mechanical ventilation which was under ventilation from basal line

  3. Proportion of patients which needed mechanical ventilation during study [ Time Frame: hospitalization within 28 days ]
    Proportion of patients who do not receive mechanical ventilation at the beginning of the study and then needed mechanical ventilation during hospitalization.

  4. World Health Organization (WHO) Ordinal scale [ Time Frame: 28 days after inclusion and compared to baseline ]
    The ordinal scale is an assessment of the clinical status at the first clinical evaluation in a clinical study. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.

  5. Duration of hospitalization [ Time Frame: hospitalization within 28 days ]
    Length of hospital stay in days for hospitalization

  6. Rates of drug discontinuation [ Time Frame: hospitalization within 28 days ]
    Rates of drug discontinuation in all causes under study


Other Outcome Measures:
  1. Rates of serious adverse events [ Time Frame: Day 14th ]
    Rates of serious adverse events



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:

  • Males and females aged > 18 years;
  • Patients with flu syndrome (fever greater than 37.8C or feverish feeling referred by the patient associated with at least 1 respiratory symptom: cough, difficulty breathing, sputum production, nasal or conjunctival congestion, difficulty swallowing, sore throat, runny nose, signs cyanosis, flapping of the nose and dyspnoea);
  • Diagnosis confirmed by real-time PCR or suspected COVID-19;
  • Hospitalized patients with:
  • Moderate disease: hypoxemia with O2 saturation <93% in room air and / or respiratory rate greater than or equal to 24 incursions per minute and / or radiological evidence of pneumonia with pulmonary impairment less than 50%;

or

  • Serious illness: Hospitalized patients with hypoxemia with O2 saturation <93% in room air and / or respiratory rate greater than or equal to 24 incursions per minute with radiological evidence of pneumonia with pulmonary involvement above 50% and / or the presence of sepsis ( organ failure) or need for invasive mechanical ventilation.

Exclusion Criteria:

  • Mild cases of flu-like syndrome that do not require hospitalization or O2 saturation greater than or equal to 93% and without radiological evidence of pneumonia;
  • Liver failure or elevation of transaminases greater than 5 times;
  • Cardiac patients with electrocardiogram with extended QT interval;
  • Pregnant women;
  • Use in the last 30 days of hydroxychloroquine or azithromycin;
  • Allergy to hydroxychloroquine or azithromycin.

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): NCT04361461


Locations
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Brazil
Apsen Farmacêutica S.A.
São Paulo, Brazil, 04753-001
Sponsors and Collaborators
Apsen Farmaceutica S.A.
Federal University of São Paulo
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Responsible Party: Apsen Farmaceutica S.A.
ClinicalTrials.gov Identifier: NCT04361461    
Other Study ID Numbers: APS000/2020
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: November 19, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hydroxychloroquine
Coronavirus Infections
Severe Acute Respiratory Syndrome
Respiratory Tract Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents