Efficacy of tocilizumab in the treatment of hospitalized patients with COVD-19

Phase 3

• Conditions: COVID-19.; COVID-19, virus identified; U07.1

• Registration Number: IRCT20201024049134N2
• Lead Sponsor: Babol University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 June 2021

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Men and women of at least 18 years of age capable of providing informed consent.
Confirmation of COVID-19 with RT-PCR.
Need for hospitalization.
No need for mechanical ventilation.
No need to more than 10 L/min of supplemental oxygen by any device.
Being in a severe COVID-19 phase (at least 2 of the following): Fever > 38 ° C in the last 72 hours, Evidence of pulmonary involvement on chest x-ray (50% progression in the last 48 hours), Dependence on supplemental oxygen to maintain a blood oxygen saturation > 90%
Having at least one of the following: CRP > 50 mg/L, LDH > 350 U/L, D-Dimer > 1000 ng/m

Exclusion Criteria

Patients more than 70 years of age with a history of any of the following in the last six months: Class III / IV Heart Failure Based on the New York Heart Association (NYHA) classification, Insulin-dependent diabetes, Angina pectoris, Malignancy
Uncontrolled bacterial, fungal, or viral infection (other than COVID-19).
Active TB
Any history of any progressive neuromuscular disease.
Any previous history of treatment with immunosuppressive medications in the last 28 days.
Concomitant use of any immunosuppressive drug that puts the patient at greater clinical risk.
Any history of allergy to Tocilizumab.
Any history of receiving convalescent plasma therapy
Any history of intestinal diverticulitis or perforation
Absolute neutrophil count (ANC) < 500 or platelets < 50,000
AST or ALT > 5 times the upper limits of normal
Pregnant women or those intending to become pregnant in the next 90 days
Breastfeeding women

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The time from the administration of the agent or placebo to the need for mechanical ventilation and intubation or death for whom died before intubation (within 28 days). Timepoint: 4, 7, 14, 21 and 28 days after Tocilizumab or placebo administration. Method of measurement: Examination of the patients by the research team.

Secondary Outcome Measures

Name	Time	Method
Time since prescribing the investigated agent or placebo to the deterioration of patient status for one degree (for patients with a score of = 3 on the clinical improvement scale at the time of enrollment) or two degrees (for patients with a score = 2 on the clinical improvement scale at the time of enrollment). Timepoint: 4, 7, 14, 21, and 28 days after Tocilizumab or placebo administration. Method of measurement: Examination of the patients by the research team.;Time since the administration of the study agent or placebo to when the patients with a score of = 3 on the clinical improvement scale at the time of enrollment do not require oxygen supplementation (within 28 days). Timepoint: 4, 7, 14, 21, and 28 days after Tocilizumab or placebo administration. Method of measurement: Examination of the patients by the research team.