MedTrace Logo

Inhalation of Ciclesonide for Patients With COVID-19: A Randomised Open Treatment Study (HALT COVID-19)

NCT04381364 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2022-02-02

No results posted yet for this study

Summary

Randomized open label clinical trial carried out at study centers in Sweden, including Karolinska University Hospital, S:t Göran Hospital, Danderyd Hospital and Västmanlands Hospital. Patients with COVID-19 who are hospitalized with oxygen therapy are eligible for inclusion. Subjects are randomized to 14 days of inhalation with ciclesonide 360 µg twice daily or to standard of care. Primary outcome is duration of received supplemental oxygen therapy. Key secondary outcome is a composite outcome of death and received invasive mechanical ventilation within 30 days.

Conditions

Interventions

DRUG

Ciclesonide Inhalation Aerosol

Ciclesonide 320 µg twice daily for 14 days.

Sponsors & Collaborators

  • Karolinska University Hospital

    collaborator OTHER

  • Danderyd Hospital

    collaborator OTHER

  • Centrallasarettet Västerås

    collaborator OTHER

  • Ola Blennow, MD, PhD

    lead OTHER

Principal Investigators

  • Daniel P Andersson, MD, PhD · Karolinska University Hospital

  • Ola Blennow, MD, PhD · Capio S:t Görans Hospital and Karolinska University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-29
Primary Completion
2021-08-01
Completion
2022-01-31

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases

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 NCT04381364 on ClinicalTrials.gov