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. 2022 Mar 9;2022(3):CD015125. doi: 10.1002/14651858.CD015125

NCT04937543.

Study name Efficacy of inhaled therapies in the treatment of acute symptoms associated with COVID‐19 (TRIVID)
Methods Trial design: open‐label, RCT
Sample size: 260
Setting: probably inpatient
Language: English
Number of centres: not reported
Type of intervention: treatment
Participants Inclusion criteria:
  • men or women aged ≥ 18 years

  • PCR‐positive SARS‐CoV‐2

  • symptomatic participants must have ≥ 1 of the following symptoms: 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

  • with oxygen saturation ≥ 92% in room air at inclusion

  • with the following haematological and biochemical laboratory parameters obtained in the period of 7 days before day 0:

    • haemoglobin > 9.0 g/dL

    • absolute neutrophil count ≥ 1000 mm3

    • platelets ≥ 100,000 mm3

    • creatinine clearance ≥ 30 mL/minute using the Cockcroft‐Gault formula

    • alkaline phosphatase < 10 × upper limit of normal, AST and ALT < 10 × upper limit of normal

    • negative pregnancy test

  • Exclusion criteria:

    • with moderate or severe acute respiratory failure or needing non‐invasive ventilation or oxygen, or with oxygen saturation < 92% or tachypnoea (respiratory rate ≥ 30 breaths/minute)

    • with pre‐existing, severe, and uncontrolled organ failure, which prevents participation in the study by the investigator's judgement (non‐relevant cardiac disease)

    • diagnosed with previous asthma using inhaled or oral corticosteroids in the last 4 weeks

    • with previous use, in the last 10 days of randomisation, of inhaled, oral, or injectable corticosteroids

    • with previous diagnosis of chronic obstructive pulmonary disease, even if they are 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 or its excipients

    • any condition that, in the investigator's opinion, could compromise the participant's safety or their adherence to the study protocol

Interventions Intervention group: inhaled beclomethasone (dose not stated) + standard care; beclomethasone/formoterol/glycopyrronium (dose not stated) + standard care
Control group: standard care
Concomitant therapy: no
Outcomes Primary outcome: proportion of participants using health resources 28 days after treatment
Secondary outcome: airway obstruction using spirometry 28 days after treatment; small airway obstruction using CT 28 days after treatment
Starting date 28 June 2021
Contact information Suzana Minamoto: suzana.tanni@unesp.br
Luana Pagan: luanapagan@alunos.fmb.unesp.br
Notes Recruitment status: not yet recruiting
Prospective completion date: 30 October 2021
Date last update was posted: 30 June 2021
Sponsor/funding: UPECLIN HC FM Botucatu Unesp