I decided to re-post this because I wanted to put "New Trial!" in the title.

In the now-deleted original post, Z3rul wrote:

the ivermectin arm is a relative low dose for that stage of infection.

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This is a double-blind placebo-controlled study (good!) without a control arm (bad). (Why not? Probably because it's considered unethical to relegate patients to standard care.)

In the US we think chloroquine and hydroxychloroquine are settled issues: they don't work. Not so in Brazil, apparently. I think the Brazilian President has been an advocate for CH/HCQ. In the US, HCQ advocates would criticize this study because it doesn't include zinc.

It sounds like this study might be done and not registered until 2020-09-27: the enrollment period is 2020-05-01 - 2020-07-17 and the treatment description uses the past tense.

N = 167, all subjects with confirmed coronavirus (see inclusion criteria about how that's defined)

Arms: chloroquine, hydroxychloroquine and ivermectin

Interventions:

Eligible participants were allocated in a 1: 1: 1 ratio to receive orally (or via a nasogastric tube in case of orotracheal intubation):

A) chloroquine diphosphate (450 mg, twice on day 0, and once per day) day from day 1 to day 4, total dose 2.7g); or

B) hydroxychloroquine sulfate (400 mg twice on day 0, and once a day from day 1 to day 4, total dose 2.4 g); or

C) ivermectin (14 mg once on day 0 + 1 placebo tablet on day 0 and once daily from day 1 to day 2, + 1 placebo tablet per day from day 3 to 4, total dose 42 mg) . For participants with body weight below 55 kg, the dose of ivermectin was adjusted to 10 mg each dose. The research products were produced blindly by an independent pharmacy.

3 doses of ivermectin, on days 0, 1 and 2, in the range of 30mg total for patients < 55kg (121 pounds) to 42mg total for patients 55+ kg.

I wonder why they didn't go for 5 days of ivermectin with an initial double-dose, like they did with the other medications.

Good blinding:

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.

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.

dyspnea = shortness of breath

tachypnea = abnormally rapid breathing

PaO2 = partial pressure of oxygen, a measurement of oxygen pressure in arterial blood

Fi02 = fraction of inspired oxygen, the concentration of oxygen in the gas mixture

infiltrate pulmonary == a substance denser than air, such as pus, blood, or protein, which lingers within the parenchyma of the lungs. Pulmonary infiltrates are associated with pneumonia, tuberculosis, and nocardiosis. Pulmonary infiltrates can be observed on a chest radiograph.

parenchyma = the functional tissue of an organ as distinguished from the connective and supporting tissue.

tomography = a technique for displaying a representation of a cross section through a human body or other solid object using X-rays or ultrasound.

Why are the inclusion criteria so complicated? It sounds like PCR wasn't available for a lot of patients? It seems like these criteria, esp. "positive serologic test IgM" will get patients at late stages of disease. When in the ordinary course does IgM show up?

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

CH/HCQ are hazardous for patients with prolongation of the QT interval.

Primary outcomes:

* need for supplemental oxygen
need for invasive ventilation
need for admission to the intensive care unit (ICU)

Secondary outcomes: mortality

I didn't spot a definition of the time frame for the outcomes. 14 days is common in other trials.

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