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Protective Role of Inhaled Steroids for Covid-19 Infection

NCT04331054 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2021-08-03

No results posted yet for this study

Summary

We hypothesize that inhaled steroid therapy and long acting beta 2 adrenergic agonist, widely prescribed in asthma patients, may also have a local protective effect against coronavirus infection, even in patients without asthma.

The primary purpose is To compare time to clinical improvement in patients receiving standard of care associated to the combination budesonide/formoterol or standard of care only.

Time (in days) to clinical improvement is defined as the time from randomization to an improvement of two points (from the status at randomization) on a seven-category ordinal scale or live discharge from the hospital, whichever came first within 30 days.

Conditions

  • Covid-19 Infection
  • Hospitalization in Respiratory Disease Department

Interventions

DRUG

2: Usual practice + SYMBICORT RAPIHALER

2 puffs bid during 30 days by inhalation

OTHER

1: Usual practice

Usual practice

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Camille TAILLE, MD, PhD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-13
Primary Completion
2021-05-28
Completion
2021-05-28

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04331054 on ClinicalTrials.gov