Safety and Efficacy of Hydroxychloroquine Associated With Azithromycin in SARS-CoV2 Virus (Coalition Covid-19 Brasil II)

Hospital Israelita Albert Einstein

Status and phase

Completed

Phase 3

Conditions

Pneumonia, Viral

Coronavirus Infections

Treatments

Drug: Hydroxychloroquine

Drug: Hydroxychloroquine + azithromycin

Study type

Interventional

Funder types

Other

NETWORK

Industry

Identifiers

NCT04321278

30155020.5.1001.0071

Details and patient eligibility

About

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.

Full description

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.

Enrollment

440 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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