The effect of chloroquine, hydroxychloroquine OR ivermectin in patients with severe manifestations of coronavirus

• Register: REBEC
• Last refreshed on: 29 May 2023
• Main ID: RBR-8h7q82
• Date of registration: 02/10/2020
• Prospective Registration: No
• Primary sponsor: Universidade Federal de Roraima
• Public title: The effect of chloroquine, hydroxychloroquine OR ivermectin in patients with severe manifestations of coronavirus
• Scientific title: Phase II study on chloroquine and hydroxychloroquine in patients with manifestations serious cases of COVID-19 infection
• Date of first enrolment: 01/05/2020
• Recruitment status: Recruitment completed
• URL: http://ensaiosclinicos.gov.br/rg/RBR-8h7q82
• Study type: Intervention
• Study design: Clinical trial of treatment, randomized-controlled, double-blind, parallel, with three arms
• Phase: 2

Countries of recruitment

Brazil

Contacts

• Name: Allex Jardim Fonseca
• Affiliation: Universidade Federal de Roraima

• Name: ruy guilherme de souza silveira
• Affiliation: Universidade Federal de Roraima

Key inclusion & exclusion criteria

Inclusion criteria: laboratory test confirming infection by SARS-CoV-2 (positive serologic test IgM or rt-PCR); hospitalized with a clinical, epidemiological and radiological picture compatible with COVID-19; over 18 years old; present a severe form of the disease characterized by one of the following clinical signs: dyspnea, tachypnea (more than 30 irpm), peripheral oxygen saturation less than 93% (pulse oximeter evaluation), PaO2 / FiO2 ratio less than 300, or infiltrate pulmonary more than 50% of the parenchyma seen on chest tomography or chest radiography
Exclusion criteria: under 18 years old; indigenous people; patients not fluent in Portuguese; unable to understand the objectives and methods of the study; critically ill patients who are not accompanied by legal representatives; those who reject participation in the study; patients with cardiac arrhythmia that include prolongation of the QT interval; previous use of any of the medications surveyed for more than 24 hours

Age minimum: 18Y
Age maximum: 100Y
Gender: -

Health Condition(s) or Problem(s) studied

Coronavirus, non specifed location coronavirus infection

b34.2

Intervention(s)

Drug

Eligible participants were allocated at a 1:1:1 ratio to receive orally (or via nasogastric tube in case of orotracheal intubation) either: A) chloroquine difosfate (450mg, twice in day 0, and once daily from day 1 to day 4, total dose 2.7g); or B) hydroxychloroquine sulfate (400mg twice in day 0, and once daily from day 1 to day 4, total dose 2.4g); or C) ivermectine (14mg once at day 0 + 1 placebo tablet at day 0, and once daily from day 1 to day 2, + 1 placebo tablet daily from day 3 to 4, total dose 42mg). For participants with body weight under 55kg, ivermectine dose was adjusted to 10mg each dose. Investigational products were produced blindly by an independent pharmacy. Placebo tablets were also produced by the same pharmacy in order to standardize treatment and blinding of research team and participants.

D002738

D02.540.576.500.997

D006886

Primary Outcome(s)

need for admission to the intensive care unit (ICU),

need for invasive ventilation,

The study end points were: need for supplemental oxygen,

Secondary Outcome(s)

mortality.

Source(s) of Monetary Support

Universidade Federal de Roraima

Secondary Sponsor(s)

Universidade Federal de Roraima