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

NCT04361461 | Withdrawn Phase 3

• 1 other identifier: APS000/2020
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Individual response rate

  The individual response rate regarding the World Health Organization Ordinal Scale assessment from basal to 14th Day.

  14 days after randomization

Secondary Outcomes (6)

• All-cause mortality

  28 days after randomization

• Duration of mechanical ventilation

  baseline

• Proportion of patients which needed mechanical ventilation during study

  hospitalization within 28 days

• World Health Organization (WHO) Ordinal scale

  28 days after inclusion and compared to baseline

• Duration of hospitalization

  hospitalization within 28 days

Other Outcomes (1)

• Rates of serious adverse events

  Day 14th

Study Arms (2)

Group 1

EXPERIMENTAL

Hydroxychloroquine (400 mg)

Drug: Hydroxychloroquine Sulfate

Group 2

EXPERIMENTAL

Hydroxychloroquine (400 mg) + azithromycin (500 mg)

Drug: Hydroxychloroquine Sulfate + Azythromycin

Interventions

Hydroxychloroquine Sulfate DRUG

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

Also known as: Reuquinol®

Group 1

Hydroxychloroquine Sulfate + Azythromycin 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.

Also known as: Reuquinol® + Azythromycin

Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Apsen Farmaceutica S.A.: lead
• Federal University of São Paulo: collaborator

Study Sites (1)

Apsen Farmacêutica S.A.

São Paulo, 04753-001, Brazil

Location

MeSH Terms

Conditions

Coronavirus Infections; Severe Acute Respiratory Syndrome; Lung Diseases

Interventions

Hydroxychloroquine; Azithromycin

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2020
• First Posted: April 24, 2020
• Study Start: April 30, 2020
• Primary Completion: November 4, 2020
• Study Completion: November 4, 2020
• Last Updated: November 19, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)