Coronavirus Infections, Pulmonary Disease, SARS-CoV 2, SARS (Severe Acute Respiratory Syndrome)
Conditions
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.
Interventions
DRUGHydroxychloroquine Sulfate
400 mg orally, every 12 hours x 2 doses (loading dose) and then 400 mg, once daily, orally, for 10 days.
DRUGHydroxychloroquine 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.
Sponsors
Apsen Farmaceutica S.A.
Federal University of São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Individual response rate | 14 days after randomization | The individual response rate regarding the World Health Organization Ordinal Scale assessment from basal to 14th Day. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality | 28 days after randomization | All-cause mortality rates at Day 28th after randomization |
| Duration of mechanical ventilation | baseline | Number of days that the patient was on mechanical ventilation which was under ventilation from basal line |
| Proportion of patients which needed mechanical ventilation during study | 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. |
| World Health Organization (WHO) Ordinal scale | 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. |
| Duration of hospitalization | hospitalization within 28 days | Length of hospital stay in days for hospitalization |
| Rates of drug discontinuation | hospitalization within 28 days | Rates of drug discontinuation in all causes under study |
Countries
Brazil
Outcome results
None listed