Hydroxychloroquine and Lopinavir/ Ritonavir to Improve the Health of People With COVID-19: "The Hope Coalition - 1"

Summary

The COVID-19 pandemic has been characterized by high morbidity and mortality, especially in certain subgroups of patients. To date, no treatment has been shown to be effective in controlling this disease in hospitalized patients with moderate and / or severe cases of this disease. Hydroxychloroquine and lopinavir / ritonavir have been shown to inhibit SARS-CoV viral replication in experimental severe acute respiratory symptoms models and have similar activity against SARS-CoV2. Although widely used in studies of critically ill patients, to date, no study has demonstrated its role on the treatment of high-risk, newly diagnosed patients with COVID-19 and mild symptoms.

Conditions

• COVID-19
• Coronavirus Infection
• Virus Disease
• Acute Respiratory Infection
• SARS-CoV Infection

Interventions

DRUG

Hydroxychloroquine Sulfate Tablets

Tablets of 400 mg: Loading dose of 02 tablets followed by one tablet of 400 mg orally on the following 09 days

DRUG

Lopinavir/ Ritonavir Oral Tablet

tablets of 200/ 50 mg; Loading dose of 04 tablets twice a day on day 1 followed by two tablets twice a day on the following 09 days

DRUG

Hydroxychloroquine Sulfate Tablets plus Lopinavir/ Ritonavir Oral Tablets

Hydroxychloroquine Oral Tablet 400 mg: Loading dose of 02 tablets followed by one tablet of 400 mg orally on the following 09 days plus Lopinavir/ Ritonavir Oral Tablet of 200/ 50 mg: Loading dose of 04 tablets twice a day on day 1 followed by two tablets twice a day on the following 09 days

DRUG

Placebo

Placebo tablets - 01 tablet twice daily from day 01 through day 10.

Sponsors & Collaborators

• Cardresearch - Cardiologia Assistencial e de Pesquisa LTDA

  collaborator UNKNOWN

• Cytel Inc.

  collaborator INDUSTRY

• Cardresearch

  lead OTHER

Principal Investigators

• Gilmar Reis, MD, PhD · Cardresearch - Cardiologia Assistencial e de Pesquisa LTDA

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-06-03

Primary Completion

2021-02-01

Completion

2021-02-01

Countries

• Brazil

Study Locations