Status:
COMPLETED
Efficacy of Chloroquine or Hydroxychloroquine in Treating Pneumonia Caused by SARS-Cov-2 - COVID-19
Lead Sponsor:
Centro de Estudos e Pesquisa em Emergencias Medicas e Terapia Intensiva
Conditions:
COVID
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 dru...
Detailed Description
This is a Phase 3, Pragmatic, Multicentric Randomized Controled Trial of efficacy to test the effect of either Chloroquine or Hydroxychloroquine for 5 days in the recomended dose standardized by brazi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 3 2020
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT04420247
Start Date
April 16 2020
End Date
September 3 2020
Last Update
May 12 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Centro de Estudos e Pesquisa em Emergencias Clinicas e Terapia Intensiva
Curitiba, Paraná, Brazil, 82530200