Use of Hydroxychloroquine Alone or Associated for Inpatients With SARS-CoV2 Virus (COVID-19)
Status:
Withdrawn
Trial end date:
2020-11-04
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Apsen Farmaceutica S.A.
Collaborators:
Federal University of São Paulo Hospital São Paulo