Overview
Efficacy of Chloroquine or Hydroxychloroquine in Treating Pneumonia Caused by SARS-Cov-2 - COVID-19
Status:
Completed
Completed
Trial end date:
2020-09-03
2020-09-03
Target enrollment:
0
0
Participant gender:
All
All
Summary
Facing the challenge of finding an efficient treatment for COVID-19, the viral pneumonia caused by the Coronavirus SARS-Cov-2, this study intended to test if Chloroquine or Hydroxychloroquine, two drugs with strong in-vitro antiviral role proven by numerous studies and with a well defined safety profile established, for efficacy in treating COVID-19 and improving an ordinal primary outcome composed by a 9-levels scale, which was recomended by the World Health Organization.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Centro de Estudos e Pesquisa em Emergencias Medicas e Terapia IntensivaTreatments:
Chloroquine
Hydroxychloroquine
Criteria
Inclusion Criteria:- Adult Males and non-pregnant females that accept and sign the informed consent.
- Hospitalized with COVID-19 suspection that has collected the confirmatory test
- To have at least one of thes symptoms: Fever, coughing, throat ache or runny nose.
- To have at least one of these findings: radiological findings that indicates COVID-10
(bilatareal ground grass images); O2 saturation lower than 94% without supplementation
and crackles in lung auscultation; Need of O2 supplementation; Need of Mechanical
Ventilation.
- Female patients must also agree to use efficient counterceptive methods during the
evaluation period.
Exclusion Criteria:
- Patients with psoriasis or other exfoliative disease, porphyria, epilepsy, myasthenia
gravis, advanced liver failure or glucose-6-phosphate dehydrogenase deficiency.
- ALT / AST> 5 times the upper limit of normal.
- Severe chronic kidney disease in stage 4 or requiring dialysis (ie, eGFR <30).
- Pregnancy or breastfeeding.
- Early transfer to another hospital that is not a study site within 72 hours.
- Severe heart disease and / or a history of cardiac arrhythmia.
- Allergy to Chloroquine and / or Hydroxychloroquine.