Efficacy of Chloroquine or Hydroxychloroquine in Treating Pneumonia Caused by SARS-Cov-2 - COVID-19

• Status: Completed
• Trial end date: 2020-09-03
• Target enrollment: 0
• Participant gender: 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 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centro de Estudos e Pesquisa em Emergencias Medicas e Terapia Intensiva
• Treatments: 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.