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

Phase 3

Withdrawn

• Conditions: SARS-CoV 2; SARS (Severe Acute Respiratory Syndrome); Coronavirus Infections; Pulmonary Disease
• Interventions: Drug: Hydroxychloroquine Sulfate + Azythromycin; Drug: Hydroxychloroquine Sulfate

• Registration Number: NCT04361461
• Lead Sponsor: Apsen Farmaceutica S.A.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-22
• Study First Submitted QC: 2020-04-23
• Study First Posted: 2020-04-24
• Study Start: 2020-04-30
• Status Verified: 2020-06
• Primary Completion: 2020-11-04
• Study Completion: 2020-11-04
• Last Update Submitted: 2020-11-18
• Last Update Posted: 2020-11-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	Hydroxychloroquine Sulfate + Azythromycin	Hydroxychloroquine (400 mg) + azithromycin (500 mg)
Group 1	Hydroxychloroquine Sulfate	Hydroxychloroquine (400 mg)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Apsen Farmacêutica S.A.; 🇧🇷 São Paulo, Brazil