COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05196581

Suzana Minamoto, Ph.D.

suzana.tanni@unesp.br

2022-01-19

Recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

inclusion criteria: a. adult males or females (≥ 18 years of age), not hospitalized, diagnosed with sars-cov-2 infection by oropharyngeal rt-pcr or swab antigen test, with mild symptoms of infection. b. symptomatic participants must have at least 1 of the following symptoms at inclusion: fever or fever perceived for more than 24 hours, headache, sore throat, nasal obstruction, dry cough, fatigue, chest pain, or choking sensation (no associated respiratory distress ), myalgia, anosmia, ageusia or gastrointestinal symptoms within 10 days of onset; c. participants with arterial pulse oximetry (spo2) saturation ≥ 92% in room air at inclusion; d. participants with the following hematological and biochemical laboratory parameters obtained within 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 by cockcroft-gault formula rapid negative pregnancy test for women of childbearing age. and. participants must understand, sign and date the voluntary written consent form at the visit prior to any protocol-specific procedure; f. participants must be able and willing to comply with study visits and procedures as per protocol.

a. moderate or severe acute respiratory failure, or requiring non-invasive ventilation or oxygen, or with spo2 <92% or tachypnea (respiratory rate ≥30 breaths/minute); b. serious and uncontrolled preexisting organ insufficiency, which prevents participation in the study by the investigator's judgment; c. diagnosis of previous asthma using inhaled or oral corticosteroids in the last four weeks; d. previous use, in the last ten days of randomization, of inhaled, oral or intravenous corticosteroids; hydroxychloroquine and dewormers. e. previous diagnosis of chronic obstructive pulmonary disease, even when not using any inhaled medication; f. pregnant or lactating women; g. use of any investigational or unrecorded product within the 3 month period or the 5 half-lives period prior to the baseline period, whichever is longer; h. any condition that, in the investigator's opinion, could compromise the participant's safety or adherence to the study protocol.

3

UPECLIN HC FM Botucatu Unesp

18

100

Brazil

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

100

Symptomatic clinic improvement

None

Phase 2

[{"arm_notes": "5 sessions", "treatment_id": 2126, "treatment_name": "Sodium chloride", "treatment_type": "Nasal spray", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "10 sessions", "treatment_id": 2126, "treatment_name": "Sodium chloride", "treatment_type": "Nasal spray", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]