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OpenTrials
Completed

NCT Number: NCT04355637

Inhaled Corticosteroid Treatment of COVID19 Patients With Pneumonia

Randomized, prospective, controlled open label clinical trial aimed at investigating if the addition of inhaled corticosteroids (budesonide) reduces treatment failure (defined as a composite variable by the initiation of treatment with high flow-O2 therapy, non-invasive or invasive ventilation, systemic steroids, use of biologics (anti IL-6 or anti IL-1) and/or death) according to hospital standard of care guidance) at day 15 after initiation of therapeutic intervention.

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Key information

Conditions

Coronavirus Infection Coronaviridae Infections Coronavirus Infections Infections Nidovirales Infections RNA Virus Infections Virus Diseases

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CEMIC (Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno"), Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • COVID19 positive
  • hospitalized because of pneumonia (status #3 - #4 World Health Organization (WHO) scale)
  • without contraindications to receive study treatment
  • informed consent

Exclusion criteria

  • receiving corticoids (inhaled or systemic)
  • receiving anti Interleukin-1 (IL-1) or anti-IL-6 drugs
  • receiving high flow oxygen therapy
  • receiving mechanical ventilation
  • pregnancy
  • participating in another intervention trial for COVID19

Treatment and study plan

Inhaled budesonide

Drug

adding budesonide to standard of care for pneumonia in COVID19 positive patients

Primary outcomes

  1. Proportion of patients in both arms fulfilling the criteria for treatment failure

    Time frame: 15 days after treatment

    composite variable that includes the initiation of treatment with high flow-O2 therapy, non-invasive or invasive ventilation and/or death) at day 15 after initiation of therapeutic intervention

Secondary outcomes

  1. ICU admission

    Time frame: baseline, day 3, day 7, day 15, day 30

    Yes/no

  2. ICU refusal

    Time frame: baseline, day3, day 7, day 15, day 30

    yes/no and reason

  3. Occurrence of complications

    Time frame: baseline, day3, day 7, day 15, day 30

    infectious cardiovascular and /or metabolic complications as well as variation in the 7 point WHO scale.

  4. lactate dehydrogenase (LDH)

    Time frame: at baseline, day 3, day 7, day 15, day 30

    U/L

  5. C Reactive Protein (CRP)

    Time frame: at baseline, day 3, day 7, day 15, day 30

    mg/dL

  6. ferritin

    Time frame: at baseline, day 3, day 7, day 15, day 30

    ng/mL

  7. D-dimer

    Time frame: at baseline, day 3, day 7, day 15, day 30

    ng/mL

  8. leukocyte counts

    Time frame: at baseline, day 3, day 7, day 15, day 30

    x10^9/L

Sponsors and collaborators

Lead sponsor

Sara Varea

Other

Registry information

Official study title

Treatment With Inhaled Corticosteroids in Patients Hospitalized Because of COVID19 Pneumonia

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 21, 2020
Registry last updated
Sep 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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