Randomized, Unicentric, Open, Controlled Clinical Trial, in Phase Iii, to Demonstrate the Effectiveness of Tocilizumab
NCT05002517 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2021-08-12
Summary
Randomized, open, single-center, controlled clinical trial, with 2 treatment arms that seeks to demonstrate the effectiveness of tocilizumab against systemic corticosteroids, both treatments added to supportive treatment in patients admitted for COVID-19 with bilateral pneumonia and poor evolution
Conditions
Interventions
- DRUG
-
Tociliziumab group
Tocilizumab is a humanized recombinant IgG1 monoclonal antibody to human interleukin-6 (IL-6) receptor, produced in Chinese hamster ovary cells by recombinant DNA technology.
- DRUG
-
Methylprednisolone group
Methylprednisolone belongs to a group of medicines called corticosteroids (it works at the cellular level by reducing the production of substances that cause inflammation or allergy).
Sponsors & Collaborators
-
Biogipuzkoa Health Research Institute
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 99 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2020-09-03
- Primary Completion
- 2021-07-31
- Completion
- 2021-10-31
Countries
- Spain
Study Locations
More Related Trials
-
Study of the Efficacy and Safety of MEDI4893
NCT02296320 ·Status: COMPLETED ·Phase: PHASE2
-
To Evaluate the Safety, Tolerability, and Efficacy of TMC207 as Part of an Individualized Multi-drug Resistant Tuberculosis (MDR-TB) Treatment Regimen in Participants With Sputum Smear-positive Pulmonary MDR-TB.
NCT00910871 ·Status: COMPLETED ·Phase: PHASE2
-
To Evaluate SCTA01 Treatment of High-risk Outpatients With COVID-19
NCT04709328 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2/PHASE3
-
Phase II Study of Amithiozone (Thiacetazone) for Patients With Mycobacterium Avium Complex Pulmonary Disease
NCT00004689 ·Status: COMPLETED ·Phase: PHASE2
-
Study of "Sputnik Lite" for the Prevention of COVID-19 With Altered Antigenic Composition.
NCT06057025 ·Status: UNKNOWN ·Phase: PHASE3
-
The COVID-19 Back-to-Normal Study: Analysis of Multiple Outcomes
NCT04832932 ·Status: ACTIVE_NOT_RECRUITING
-
TMC207-TiDP13-C208: Anti-bacterial Activity, Safety, and Tolerability of TMC207 in Participants With Multi-drug Resistant Mycobacterium Tuberculosis (MDR-TB).
NCT00449644 ·Status: COMPLETED ·Phase: PHASE2
-
TMC207-C202: Study to Evaluate Bactericidal Activity of Multiple Oral Doses of TMC207 in Subjects With Sputum-Smear Positive Tuberculosis
NCT00523926 ·Status: COMPLETED ·Phase: PHASE2
-
Prevention, Efficacy and Safety of BCG Vaccine in COVID-19 Among Healthcare Workers
NCT04461379 ·Status: UNKNOWN ·Phase: PHASE3
-
Short-term Bactericidal Effect of Contezolid in MAC-PD
NCT07084402 ·Status: RECRUITING ·Phase: PHASE4
-
Staphylococcus Aureus Toxoids Phase 1-2 Vaccine Trial
NCT01011335 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI4893 in Healthy Adult Subjects
NCT01769417 ·Status: COMPLETED ·Phase: PHASE1
-
Clinical Impact of BACTEK-R in Subject With Mild Pneumonia Due to COVID-19 Infection
NCT04363814 ·Status: UNKNOWN ·Phase: PHASE3
-
Human Immunity Against Staphylococcus Aureus Skin Infection
NCT02262819 ·Status: COMPLETED ·Phase: PHASE1
-
Safety & Efficacy of True Human Antibody, 514G3, in Staphylococcus Aureus Bacteremia Hospitalized Subjects.
NCT02357966 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Study the Safety and Efficacy of PTK 0796 in Patients With Complicated Skin and Skin Structure Infection (CSSSI)
NCT00865280 ·Status: TERMINATED ·Phase: PHASE3
-
TOCILIZUMAB - An Option for Patients With COVID-19 Associated Cytokine Release Syndrome; A Single Center Experience
NCT04730323 ·Status: COMPLETED ·Phase: PHASE4
-
Study to Investigate the Safety, Tolerability, and Pharmacokinetics of DSTA4637S in Participants With Staphylococcus Aureus Bacteremia Receiving Standard-of-Care (SOC) Antibiotics
NCT03162250 ·Status: COMPLETED ·Phase: PHASE1
-
Study the Efficacy and Safety of PTK 0796 in Patients With Complicated Skin and Skin Structure Infection (CSSSI)
NCT03716024 ·Status: COMPLETED ·Phase: PHASE2
-
Clinical Study in the Treatment of Patients With Moderate Course of COVID-19
NCT04842435 ·Status: UNKNOWN ·Phase: PHASE2/PHASE3
-
Microbial Cell-free Metagenomic Sequencing for Suspected Infections in Adult Immunocompromised Outpatients
NCT07110636 ·Status: RECRUITING ·Phase: NA
-
EU SolidAct: An Adaptive Pandemic and Emerging Infection Platform Trial
NCT04891133 ·Status: TERMINATED ·Phase: PHASE2/PHASE3
-
Different Susceptibility to SARS CoV-2 Infection Among Health Care Workers Highly Exposed to COVID-19.
NCT04402827 ·Status: COMPLETED
-
Early Bactericidal Activity, Safety & Tolerability of Oral GSK3036656 in a Dual Combination With Novel and Established Antitubercular Agents, or Standard of Care in Adults With Rifampicin Susceptible Pulmonary Tuberculosis
NCT05382312 ·Status: COMPLETED ·Phase: PHASE2
-
The BLAST- 1 Trial - Cephalexin+Amoxicillin-clavulanate for Tuberculosis
NCT05664568 ·Status: UNKNOWN ·Phase: PHASE2