Inhaled Corticosteroid Treatment of COVID19 Patients With Pneumonia

Sara Varea

Status and phase: Completed; Phase 4

Conditions: Coronavirus Infection

Treatments: Drug: Inhaled budesonide

Study type: Interventional

Funder types: Other

Identifiers

NCT04355637

2020-001616-18 (EudraCT Number)

TACTIC-COVID

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Control

No Intervention group

Description:

patients receiving standard of care to treat their pneumonia

Intervention

Experimental group

Description:

patients receiving standard of care to treat their pneumonia + inhaled budesonide

Treatment:

Drug: Inhaled budesonide