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

Last updated: November 18, 2020
Sponsor: Apsen Farmaceutica S.A.
Overall Status: Trial Not Available

Phase

3

Condition

Lung Disease

Treatment

N/A

Clinical Study ID

NCT04361461
APS000/2020
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Males and females aged > 18 years;
  • Patients with flu syndrome (fever greater than 37.8C or feverish feeling referred bythe patient associated with at least 1 respiratory symptom: cough, difficultybreathing, 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 respiratoryrate greater than or equal to 24 incursions per minute and / or radiological evidenceof pneumonia with pulmonary impairment less than 50%; or
  • Serious illness: Hospitalized patients with hypoxemia with O2 saturation <93% in roomair and / or respiratory rate greater than or equal to 24 incursions per minute withradiological evidence of pneumonia with pulmonary involvement above 50% and / or thepresence of sepsis ( organ failure) or need for invasive mechanical ventilation.

Exclusion

Exclusion Criteria:

  • Mild cases of flu-like syndrome that do not require hospitalization or O2 saturationgreater 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 Start date:
April 30, 2020
Estimated Completion Date:
November 04, 2020

Connect with a study center

  • Apsen Farmacêutica S.A.

    São Paulo, 04753-001
    Brazil

    Site Not Available

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