Use of Hydroxychloroquine Alone or Associated for Inpatients With SARS-CoV2 Virus (COVID-19)

Apsen Farmaceutica

Status and phase: Withdrawn; Phase 3

Conditions: SARS (Severe Acute Respiratory Syndrome); SARS-CoV 2; Pulmonary Disease; Coronavirus Infections

Treatments: Drug: Hydroxychloroquine Sulfate + Azythromycin; Drug: Hydroxychloroquine Sulfate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04361461

APS000/2020

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

0 participants in 2 patient groups

Group 1

Experimental group

Description:

Hydroxychloroquine (400 mg)

Treatment:

Drug: Hydroxychloroquine Sulfate

Group 2

Experimental group

Description:

Hydroxychloroquine (400 mg) + azithromycin (500 mg)

Treatment:

Drug: Hydroxychloroquine Sulfate + Azythromycin