Randomized Placebo-controlled Trial of Hydroxychloroquine in Outpatient Cases With Coronavirus Disease 2019 (COVID-19)

• Status: Active, not recruiting
• Trial end date: 2021-08-28
• Target enrollment: 0
• Participant gender: All

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 now there is no proof of effectiveness of any specific intervention. Some limited observational trials and also evidence from randomized trials have shown no benefit of hydroxychloroquine in inpatient context. Thus, studies evaluating interventions in an outpatient setting in non-severe patients can provide important information related to prognosis and safety. In this way, the present study will evaluate the effectiveness and safety of the use of hydroxychloroquine in COVID-19 outpatients by means of a Randomized, double-blind, placebo-controlled trial

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Alemão Oswaldo Cruz
• Collaborators: Brazilian Research In Intensive Care Network; EMS S/A; Hospital do Coracao; Hospital Israelita Albert Einstein; Hospital Moinhos de Vento; Hospital Sirio-Libanes
• Treatments: Hydroxychloroquine

Criteria

Inclusion Criteria:

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:

1. > 65 years;

2. Hypertension;

3. Diabetes mellitus;

4. Asthma;

5. COPD or other chronic lung diseases;

6. Smoking;

7. Immunosuppression;

8. Obesity (Defined as BMI equal to or greater than 30 Kg/m2).

Exclusion Criteria:

1. Patients under 18 years old;

2. Hospitalization at the first medical care;

3. Positive test for influenza at the first medical care;

4. Known hypersensitivity to hydroxychloroquine / chloroquine;

5. Previous diagnosis of retinopathy or macular degeneration;

6. 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;

7. Evidence of known liver disease, reported by the patient;

8. Evidence of known chronic kidney disease, reported by the patient;

9. Patients with pancreatitis;

10. Baseline ECG with QTc interval ≥ 480ms;

11. Chronic use of hydroxychloroquine/chloroquine for other reasons;

12. Pregnancy.