Effects of Early Use of Nitazoxanide in Patients With COVID-19

• Status: Completed
• Trial end date: 2020-09-05
• Target enrollment: 0
• Participant gender: All

Summary

Multicenter, randomized, placebo-controlled, parallel, blinded, interventional, treatment clinical trial with two arms.

Population: 392 Patients with COVID-19 (Coronavirus Disease-19), confirmed by RT-PCR (Real Time polymerase chain reaction), symptomatic in the early phase of the disease.

Experimental group: 196 patients, nitazoxanide 500mg 8 / 8 hours for 5 days. Control group:

196 patients, placebo 8/8 hours for 5 days.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universidade Federal do Rio de Janeiro
• Collaborators: ATCGen; Complexo Hospitalar Municipal de São Caetano do Sul; Hospital de Transplante Doutor Euryclides de Jesus Zerbini; Hospital e Maternidade Therezinha de Jesus; Ministry of Science and Technology, Brazil; National Research Council, Brazil; Santa Casa de Misericórdia de Sorocaba; Secretaria de Estado de Saúde do Distrito Federal; Secretaria Municipal de Saúde de Bauru; Secretaria Municipal de Saúde de Guarulhos
• Treatments: Nitazoxanide

Criteria

Inclusion Criteria:

• Clinical scenario compatible with infection by the SARS-CoV-2 [Characteristic symptoms of COVID-19 (fever and / or cough and / or fatigue)

• Beginning 1 to 3 days before inclusion in the study

• Age equal or superior to 18 years

• Willingness to receive study treatment

• Providing written and informed consent or the same consent signed by a family member

Exclusion Criteria:

• Negative result of RT-PCR for SARS-COV2 collected on admission

• Impossibility to use oral medications

• History of severe liver disease (Child Pugh C class)

• Previous renal failure

• Severe heart failure (NYHA 3 or 4)

• COPD (GOLD 3 and 4)

• Neoplasia in the last 5 years

• Known autoimmune disease

• Individuals with known hypersensitivity to study drug

• Previous treatment with the study medication during the last 30 days

• Clinical suspicion of tuberculosis and bacterial pneumonia