Safety and Efficacy of Hydroxychloroquine Associated With Azithromycin in SARS-CoV2 Virus (Coalition Covid-19 Brasil II)
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| ClinicalTrials.gov Identifier: NCT04321278 |
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Recruitment Status :
Completed
First Posted : March 25, 2020
Last Update Posted : January 20, 2021
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Sponsor:
Hospital Israelita Albert Einstein
Collaborators:
EMS
Hospital do Coracao
Hospital Sirio-Libanes
Brazilian Research In Intensive Care Network
Information provided by (Responsible Party):
Hospital Israelita Albert Einstein
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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 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Coronavirus Infections Pneumonia, Viral | Drug: Hydroxychloroquine + azithromycin Drug: Hydroxychloroquine | Phase 3 |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 440 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: |
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| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | 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 |
| Actual Study Start Date : | March 28, 2020 |
| Actual Primary Completion Date : | June 14, 2020 |
| Actual Study Completion Date : | June 14, 2020 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Hydroxychloroquine + azithromycin
Hydroxychloroquine [400mg 2x/day, 12/12h] + azithromycin [500mg 1x/day]
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Drug: Hydroxychloroquine + azithromycin
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 Name: HCQ+AZI |
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Active Comparator: Hydroxychloroquine
Hydroxychloroquine [400mg 2x/day, 12/12h]
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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 Name: HCQ |
Primary Outcome Measures :
- Evaluation of the clinical status [ Time Frame: 15 days after randomization ]Evaluation of the clinical status of patients on the 15th day after randomization defined by the Ordinal Scale of 6 points (score ranges from 1 to 6, with 6 being the worst score)
Secondary Outcome Measures :
- All-cause mortality [ Time Frame: 29 days after randomization ]All-cause mortality rates at 29 days after randomization
- Evaluation of the clinical status [ Time Frame: 7 and 29 days after randomization ]Evaluation of the clinical status of patients on the 7th and 29th day after randomization defined by the Ordinal Scale of 6 points (score ranges from 1 to 6, with 6 being the worst score)
- Number of days free from mechanical ventilation [ Time Frame: 29 days after randomization ]Number of days free from mechanical ventilation at 29 days after randomization
- Duration of mechanical ventilation [ Time Frame: 29 days after randomization ]Number of days that the patient was on mechanical ventilation after randomization
- Duration of hospitalization [ Time Frame: 29 days after randomization ]Length of hospital stay on survivors
- Other secondary infections [ Time Frame: 29 days after randomization ]Presence of other secondary infections
- Time from treatment start to death [ Time Frame: 29 days after randomization ]Time from treatment start to death
- Medium and long-term outcomes of SARS-CoV2 infection on morbimortality, daily life activities, mental health, and quality of life [ Time Frame: 3, 6, 9 and 12 months ]Morbimortality, daily life activities, mental health, and quality of life
- Assess whether the tested therapies may be affected by leucocyte phenotype [ Time Frame: Baseline ]Leucocyte transcriptome
Other Outcome Measures:
- QT interval prolongation [ Time Frame: 29 days after randomization ]Occurrence of QT interval prolongation
- Gastrointestinal intolerance [ Time Frame: 29 days after randomization ]Occurrence of gastrointestinal intolerance
- Laboratory abnormalities [ Time Frame: 29 days after randomization ]Occurrence of laboratory hematimetric parameters, creatinine and bilirubin
- Adverse events [ Time Frame: 29 days after randomization ]Occurrence of adverse events related to the use of the investigational products
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;
- 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
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): NCT04321278
Locations
Show 58 study locations
Sponsors and Collaborators
Hospital Israelita Albert Einstein
EMS
Hospital do Coracao
Hospital Sirio-Libanes
Brazilian Research In Intensive Care Network
Investigators
| Study Director: | Otávio Berwanger, PhD | Hospital Israelita Albert Einstein |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Hospital Israelita Albert Einstein |
| ClinicalTrials.gov Identifier: | NCT04321278 |
| Other Study ID Numbers: |
30155020.5.1001.0071 |
| First Posted: | March 25, 2020 Key Record Dates |
| Last Update Posted: | January 20, 2021 |
| Last Verified: | March 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| 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 Hospital Israelita Albert Einstein:
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SARS-CoV2 virus 2019-nCOV COVID-19 hydroxychloroquine azithromycin |
Additional relevant MeSH terms:
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COVID-19 Coronavirus Infections Coronaviridae Infections Hydroxychloroquine Infections Pneumonia Pneumonia, Viral Respiratory Tract Infections Virus Diseases Nidovirales Infections RNA Virus Infections |
Lung Diseases Respiratory Tract Diseases Azithromycin Anti-Bacterial Agents Anti-Infective Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antirheumatic Agents |