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NCT04361461

Hydroxychloroquine or Hydroxychloroquine Associated With Azithromycin for Inpatients With Moderate or Severe Lung Disease Due to SARS-CoV-2 (COVID-19)

  1. Study Type
  2. Interventional
  1. Study Aim
  2. Treatment and Management
  1. Study Design
  2. Parallel/Crossover
  1. Intervention Assignment
  2. Randomised
  1. Population (9)
  2. Male and Female
  3. Coronavirus Infection
  4. COVID-19
  5. SARS-CoV-2 Virus
  6. Adult
  7. Aged (65+)
  1. Intervention (1)
  2. Hydroxychloroquine Sulfate
  1. Comparison (2)
  2. Azithromycin
  3. Hydroxychloroquine Sulfate
  1. Outcome (5)
  2. All Cause Mortality
  3. Treatment discontinued
  4. Hospitalization
  5. Mechanical ventilation
  6. Ordinal Scale

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

Apsen Farmaceutica S.A.
First Published (first received 2020 Apr 24)ClinicalTrials.gov (https://clinicaltrials.gov/show/NCT04361461)
Trial registry record
No Results
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