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

Phase II study on chloroquine and hydroxychloroquine in patients with manifestations serious cases of COVID-19 infection

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

REBEC

Registry ID

RBR-8h7q82

Enrollment

Unknown

Registered

2020-10-02

Start date

2020-05-01

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronavirus, non specifed location coronavirus infection

Interventions

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 da

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 und

Drug

D002738

D006886

D02.540.576.500.997

Eligibility

Age

18 Years to 100 Years

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
The study end points were: need for supplemental oxygen, ;need for invasive ventilation, ;need for admission to the intensive care unit (ICU),	—

Secondary

Measure	Time frame
mortality.	—

Countries

Brazil

Contacts

Public ContactAllex;ruy Fonseca;silveira

Universidade Federal de Roraima;Universidade Federal de Roraima

allex.jardim@bol.com.br;ruysouza28@gmail.com+5595981126172;95981110123

Outcome results

None listed

Source: REBEC (via WHO ICTRP)