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

NCT ID: NCT04361461

Last Updated: 2020-11-19

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-30
• Study Completion Date: 2020-11-04

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1

Hydroxychloroquine (400 mg)

Group Type: EXPERIMENTAL

Hydroxychloroquine Sulfate

Intervention Type: DRUG

400 mg orally, every 12 hours x 2 doses (loading dose) and then 400 mg, once daily, orally, for 10 days.

Group 2

Hydroxychloroquine (400 mg) + azithromycin (500 mg)

Group Type: EXPERIMENTAL

Hydroxychloroquine Sulfate + Azythromycin

Intervention Type: DRUG

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.

Interventions

Hydroxychloroquine Sulfate

400 mg orally, every 12 hours x 2 doses (loading dose) and then 400 mg, once daily, orally, for 10 days.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Reuquinol®; Reuquinol® + Azythromycin

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of São Paulo

OTHER

Sponsor Role: collaborator

Apsen Farmaceutica S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Apsen Farmacêutica S.A.

São Paulo, , Brazil

Countries

Brazil

Other Identifiers

APS000/2020

Identifier Type: -

Identifier Source: org_study_id