Trial | NCT04321278  Report issue

Title

Safety and Efficacy of Hydroxychloroquine Associated With Azithromycin in SARS-CoV2 Virus (Coalition Covid-19 Brasil II)
Evaluation of the Safety and Clinical Efficacy of Hydroxychloroquine Associated With Azithromycin in Patients With Pneumonia Caused by Infection by the SARS-CoV2 Virus - Coalition COVID-19 Brasil II - SEVERE - Patients

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    440
The Severe Acute Respiratory Syndrome COronaVirus 2 (SARS-CoV2) is a new and recognized infectious disease of the respiratory tract. Around 20% of those infected have severe pneumonia and currently there is no specific or effective therapy to treat this disease. Therapeutic options using malaria drugs chloroquine and hydroxychloroquine have shown promising results in vitro and in vivo test. But those efforts have not involved large, carefully-conducted controlled studies that would provide the global medical community the proof that these drugs work on a significant scale. In this way, the present study will evaluate the effectiveness and safety of the use of hydroxychloroquine combined with azithromycin compared to hydroxychloroquine monotherapy in patients hospitalized with pneumonia by SARS-CoV2 virus.
The Severe Acute Respiratory Syndrome COronaVirus 2 (SARS-CoV2) is a new and recognized infectious disease of the respiratory tract that is now spreading to several countries in the world, including Brazil. Mortality rates after infection are higher in adults over 60 and with a history of comorbidities. The most serious patients need care in intensive care units (ICU). Most of the time they depend on mechanical ventilation support due to acute respiratory distress syndrome (ARDS). Infection rates are higher than the capacity for intensive care, which represents a serious problem in medical care. Around 20% of those infected have severe pneumonia and so far it does not have a specific therapy, or even, an effective clinical management. Therapeutic options using malaria drugs chloroquine and hydroxychloroquine have shown promising results in vitro and in vivo test. A recent, small, non-randomized study with hydroxychloroquine in 36 patients infected with SARS-Cov-2 proved to be promising in the ability to reset the viral load in 6 days after starting treatment. Thus, the present study will evaluate the effectiveness and safety of the use of hydroxychloroquine combined with azithromycin compared to hydroxychloroquine monotherapy in the clinical evolution by the ordinal scale of 6 points in adult patients hospitalized with pneumonia caused by infection by the SARS-CoV2 virus in Brazil.
Study Started
Mar 28
2020
Primary Completion
Jun 14
2020
Study Completion
Jun 14
2020
Last Update
Jan 20
2021

Drug Hydroxychloroquine + azithromycin [azithromycin (zithromax), hydroxychloroquine (plaquenil)]

Intervention Group: Hydroxychloroquine + azithromycin. After randomization, Hydroxychloroquine [400mg 2x/day, 12/12h] + azithromycin [500mg 1x/day]) for 10 days. Standard treatment is according to the treatment protocol for 2019-nCoV infection.

  • Other names: HCQ+AZI

Drug Hydroxychloroquine

Active Control Group: Hydroxychloroquine. After randomization, Hydroxychloroquine [400mg 2x/day, 12/12h] for 10 days. Standard treatment is according to the treatment protocol for 2019-nCoV infection.

  • Other names: HCQ

Hydroxychloroquine + azithromycin Experimental

Hydroxychloroquine [400mg 2x/day, 12/12h] + azithromycin [500mg 1x/day]

Hydroxychloroquine Active Comparator

Hydroxychloroquine [400mg 2x/day, 12/12h]

Criteria 

Inclusion Criteria:

Males and females aged > 18 years;
Suspected or confirmed infection by SARS-CoV2;

Presenting with one of the following:

Need for oxygen supplementation > 4 L/min, or
Need for high-flow nasal canula, or
Need for non-invasive ventilation, or
Need for mechanical ventilation.

Exclusion Criteria:

Refusal to provide written informed consent (either the patient or a legal representative);
Hypersensitivity to any of the drugs used in the study (Azithromycin or Hydroxychloroquine);
Patients with more than 48 hours of prior study medication use;
Patients with onset of symptoms longer than 14 days;
Patients with long QT syndrome or severe ventricular arrhythmias, not protected by an implantable cardioverter defibrillators (ICD).;
QTc>= 480ms;
Do not resuscitate order or exclusive palliative care;
Patients with liver disease or cirrhosis or abnormal liver enzyme tests above three times the upper limit values (alanine aminotransferase -ALT and aspartate aminotransferase - AST);
Patients with known retinopathy or macular degeneration;
Patients with history of pancreatitis;
Patients with concomitant use of medications that alter the absorption or excretion of azithromycin or hydroxychloroquine;
Breastfeeding women;
Pregnancy
No Results Posted