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.
Drug: Hydroxychloroquine Sulfate
400 mg orally, every 12 hours x 2 doses (loading dose) and then 400 mg, once daily, orally, for 10 days.
Other Name: Reuquinol®
Drug: Hydroxychloroquine 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.
Other Name: Reuquinol® + Azythromycin
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.
Apsen Farmacêutica S.A.
São Paulo, Brazil