Status:
COMPLETED
Safety and Efficacy of Hydroxychloroquine Associated With Azithromycin in SARS-CoV2 Virus (Coalition Covid-19 Brasil II)
Lead Sponsor:
Hospital Israelita Albert Einstein
Collaborating Sponsors:
EMS
Hospital do Coracao
Conditions:
Coronavirus Infections
Pneumonia, Viral
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 th...
Detailed 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 B...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 14 2020
Estimated Enrollment :
440 Patients enrolled
Trial Details
Trial ID
NCT04321278
Start Date
March 28 2020
End Date
June 14 2020
Last Update
January 20 2021
Active Locations (58)
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1
Hospital de Urgência e Emergência de Rio Branco
Rio Branco, Acre, Brazil
2
Hospital Maternidade São Vicente de Paulo
Barbalha, Ceará, Brazil
3
Hospital de Messejana Dr. Carlos Alberto Studart Gomes
Fortaleza, Ceará, Brazil
4
Hospital Unimed Cariri
Juazeiro do Norte, Ceará, Brazil