Status:
COMPLETED
Randomized Placebo-controlled Trial of Hydroxychloroquine in Outpatient Cases With Coronavirus Disease 2019 (COVID-19)
Lead Sponsor:
Hospital Alemão Oswaldo Cruz
Collaborating Sponsors:
EMS S/A
Hospital do Coracao
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
In December 2019, a group of patients with pneumonia of unknown cause was identified in Wuhan, in the Hubei province, China. Despite the need of target specific therapeutic options for COVID-19, until...
Detailed Description
Pragmatic, double-blind, placebo-controlled randomized parallel-group, two-arm clinical trial (with allocation ratio 1:1), evaluating hydroxychloroquine (800 mg at 1st day, and 400 mg from day 2 to 7)...
Eligibility Criteria
Inclusion
- It will be considered eligible those adults (equal to or greater than 18 years) seeking medical care with suspected or confirmed COVID-19, with time between symptoms and inclusion ≤ 07 days, presenting mild symptoms, without indication of hospitalization and at least 1 risk factor for complication:
- \> 65 years;
- Hypertension;
- Diabetes mellitus;
- Asthma;
- COPD or other chronic lung diseases;
- Smoking;
- Immunosuppression;
- Obesity (Defined as BMI equal to or greater than 30 Kg/m2).
Exclusion
- Patients under 18 years old;
- Hospitalization at the first medical care;
- Positive test for influenza at the first medical care;
- Known hypersensitivity to hydroxychloroquine / chloroquine;
- Previous diagnosis of retinopathy or macular degeneration;
- Previous diagnosis of Long QT-syndrome, history of sudden death in close family members (parents and siblings), decompensated heart failure, unstable coronary artery disease, use of anti-arrhythmic drugs or other drugs that can increase the hydroxychloroquine bioavailability or enhance its effect;
- Evidence of known liver disease, reported by the patient;
- Evidence of known chronic kidney disease, reported by the patient;
- Patients with pancreatitis;
- Baseline ECG with QTc interval ≥ 480ms;
- Chronic use of hydroxychloroquine/chloroquine for other reasons;
- Pregnancy.
Key Trial Info
Start Date :
May 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 28 2021
Estimated Enrollment :
1372 Patients enrolled
Trial Details
Trial ID
NCT04466540
Start Date
May 12 2020
End Date
September 28 2021
Last Update
March 7 2022
Active Locations (69)
Enter a location and click search to find clinical trials sorted by distance.
1
Centro de Pesquisas Clínicas Dr. Marco Mota HCOR
Maceió, Alagoas, Brazil
2
Hospital Maternidade São Vicente de Paulo
Barbalha, Ceará, Brazil
3
Hospital Unimed Cariri
Juazeiro do Norte, Ceará, Brazil
4
Unimed Sul Capixaba
Cachoeiro de Itapemirim, Espírito Santo, Brazil