COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04937543

not reported

not reported

2021-06-24

Not recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

inclusion criteria: a research participant will be eligible to participate in this study if all of the following criteria are met: adult men or women (≥ 18 years of age) pcr positive sarscov-2 symptomatic participants must have at least 1 of the following symptoms in the inclusion: fever or self-reported fever perception in the last 24 hours, headache, sore throat, dry cough, fatigue, chest pain or choking sensation (without associating to respiratory distress), myalgia, anosmia, ageusia or gastrointestinal symptoms with up to 10 days onset. participants with arterial pulse oximetry (spo2) saturation ≥ 92% in room air at inclusion. participants with the following hematological and biochemical laboratory parameters obtained in the period of 7 days before d0: hemoglobin> 9.0 g / dl-1 absolute neutrophil count ≥ 1000 mm-³ platelets ≥ 100,000 mm-3 creatinine clearance ≥ 30 ml / min-1 using the cockcroft-gault formula alkaline phosphatase <10 × upper limit of normal (lsn), ast (tgos) and alt (tgps) <10 × lsn. laboratory pregnancy test (negative β-hcg). participants must understand, sign and date the voluntary informed consent form in writing at the visit prior to any specific protocol procedure. participants must be able and willing to comply with study visits and procedures, as per the protocol.

research participants who meet any of the following exclusion criteria will be excluded from the study: participants with moderate or severe acute respiratory failure or needing non-invasive ventilation or oxygen, or with spo2 <92% or tachypnea (respiratory rate ≥ 30 breaths / minute). participants with pre-existing, severe and uncontrolled organ failure, which prevents participation in the study by the investigator's judgment (non-relevant cardiac disease) participant diagnosed with previous asthma using inhaled or oral corticosteroids in the last four weeks. participant with previous use, in the last ten days of randomization, of inhaled, oral or injectable corticosteroids. participant with previous diagnosis of chronic obstructive pulmonary disease, even if he is not using any inhaled medication. pregnant or lactating women. use of any product under investigation or unregistered within 3 months or within 5 half-lives before baseline, whichever is longer. hypersensitivity to the drug and / or its excipients. any condition that, in the investigator's opinion, could compromise the participant's safety or his adherence to the study protocol.

3

UPECLIN HC FM Botucatu Unesp

18

100

Brazil

Mild disease at enrollment

1: Mild disease at enrollment

50

Proportion of patients in preventing the use of health resources in patients

None

Phase 2

[{"arm_notes": "", "treatment_id": 2299, "treatment_name": "Beclomethasone+formoterol+glycopyrronium", "treatment_type": "Corticosteroids+respiratory agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 188, "treatment_name": "Beclametasone", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]