NCT04519385

Brief Summary

randomized controlled trial comparing survival benefit of Tocilizumab therapy with dexamethasone in patients with severe COVID 19

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2020

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

August 17, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 19, 2020

Completed
Last Updated

August 25, 2020

Status Verified

August 1, 2020

Enrollment Period

4 months

First QC Date

August 17, 2020

Last Update Submit

August 21, 2020

Conditions

Pneumonia, Viral

Keywords

COVID19Tocilizumabdexamethsone

Outcome Measures

Primary Outcomes (1)

  • Proportion of participants with Overall Survival at 14 days

    survival 14 days from admission date

    14 days

Secondary Outcomes (1)

  • Fio2/Pao2

    2 days

Study Arms (2)

Tocilizumab

EXPERIMENTAL

Tocilizumab

Drug: Tocilizumab

Dexamethasone

ACTIVE COMPARATOR

Dexamethasone therapy

Drug: Dexamethasone

Interventions

TocilizumabDRUG

Tocilizumab therapy

Also known as: TCZ
Tocilizumab
DexamethasoneDRUG

dexamethsone pulse therapy

Also known as: dexamethsone pulse therapy
Dexamethasone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • respiratory rate \> 30 cycle/minute, Bilateral CT infiltration \> 30%, PaO2/FiO2 ratio \<150 or saturation \<90 on \>6L/min, Two positive laboratory tests of: (CRP\>100 g/dL, lymphocytes\<600 /mm3, D dimer\>L, Ferritin \>500)

You may not qualify if:

  • Pediatric patients \< 18 years old, patients with active bacterial or fungal infection and patients who were not requiring supplemental oxygen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qena faculty medicine

Qina, 83523, Egypt

Location

MeSH Terms

Conditions

Pneumonia, ViralCOVID-19

Interventions

tocilizumabDexamethasone

Condition Hierarchy (Ancestors)

PneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesLung DiseasesRespiratory Tract DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus Infections

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Alaa R rashad, MD

    South Valley University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
single blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: dexamethsone group Tocilizumab group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

August 17, 2020

First Posted

August 19, 2020

Study Start

March 1, 2020

Primary Completion

July 1, 2020

Study Completion

August 5, 2020

Last Updated

August 25, 2020

Record last verified: 2020-08

Locations

EG(1)