Evaluation of efficacy and safety of an tocilizumab treatment in patients with severe COVID-19 pneumonia

Phase 1

• Conditions: Severe COVID-19 pneumonia; MedDRA version: 20.0Level: PTClassification code 10061229Term: Lung infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2020-001408-41-DE
• Lead Sponsor: niversitätsklinikum Freiburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-07
• Last Update Posted: 31 August 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1.Proof of SARS-CoV2
2.Severe respiratory failure:
a.ambient air SpO2 = 92% or
b.Need of = 6l O2/min or
c.NIV (non-invasive ventilation) or
d.IMV (invasive mechanical ventilation)
3.= 18 years
4.Written informed consent obtained from the patient or legal authorized representative or investigator consilium (Gießener Modell”) according to international guidelines and local laws;

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

1.Non-invasive or invasive mechanical ventilation = 48 hours
2.Pregnancy or breast feeding
3.Liver injury or failure (AST/ALT = 5x ULN)
4.Leukocytes < 2 × 103/µl
5.Thrombocytes < 50 × 103/µl
6.Severe bacterial infection (PCT > 3ng/ml)
7.Acute or chronic diverticulitis
8.Immunosuppressive therapy (e.g. mycophenolate, azathioprine, methotrexate, biologicals, prednisolone >10mg/d; exceptions are: prednisolone = 10mg/d, sulfasalazine or hydroxychloroquine)
9.Known active or chronic tuberculosis
10.Known active or chronic viral hepatitis
11.Known allergic reactions to tocilizumab or its ingredients
12.Life expectation of less than 1 year (independent of COVID-19)
13.Participation in any other interventional clinical trial within the last 30 days before the start of this trial
14.Simultaneous participation in other interventional trials (except for participation in COVID 19 trials) which could interfere with this trial; simultaneous participation in registry and diagnostic trials is allowed
15.Failure to use one of the following safe methods of contraception: female condoms, diaphragm or coil, each used in combination with spermicides; intra-uterine device; hormonal contraception in combination with a mechanical method of contraception;
Women can only take part in this study if the risk of becoming pregnant is absolutely minimized. Save contraceptive methods comprise: female condoms, diaphragm or coil, each used in combination with spermicides; intra-uterine device; hormonal contraception in combination with a mechanical method of contraception and have to be used while participating in the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified