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Treatment of Moderate to Severe Coronavirus Disease (COVID-19) in Hospitalized Patients

NCT04321993 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 363

Last updated 2023-09-18

No results posted yet for this study

Summary

Investigational medications adjunct to clinical standard of care treatment will be assessed to evaluate safety and effectiveness as an anti-COVID-19 treatment. All hospitalized persons with moderate to severe COVID-19 disease that meet eligibility criteria will be offered participation.

Conditions

Interventions

DRUG

Baricitinib (janus kinase inhibitor)

Baricitinib will be administered as 4 mg po daily for 14 days or until hospital discharge, whichever is sooner.

DRUG

Remdesivir (antiviral) + barictinib (janus kinase inhibitor)

Remdesivir will be administered as a loading dose of 200 mg IV over one hour on day 1 followed by 100 mg IV daily over one hour on days 2-5 (with a possibility to extend to up to 10 days total). Baricitinib will be administered as 4 mg po daily for 14 days or until hospital discharge, whichever is sooner.

DRUG

Remdesivir (antiviral)

Remdesivir will be administered as a loading dose of 200 mg IV over one hour on day 1 followed by 100 mg IV daily over one hour on days 2-5 (with a possibility to extend to up to 10 days total).

DRUG

Tocilizumab (interleukin 6 inhibitor)

Tocilizumab will be administered as a single IV infusion over one hour. Dosage will be 8 mg/kg total bodyweight up to a maximum of 800 mg.

Sponsors & Collaborators

  • Nova Scotia Health Authority

    collaborator OTHER

  • Dalhousie University

    collaborator OTHER

  • Lisa Barrett

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-17
Primary Completion
2024-04-30
Completion
2024-04-30

Countries

  • Canada

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 NCT04321993 on ClinicalTrials.gov