Experimental use of tocilizumab in COVID-19 related pneumonia.

Phase 1

• Conditions: viral pneumonia caused by the new coronavirus (SARS-CoV-2); MedDRA version: 21.1Level: PTClassification code 10035737Term: Pneumonia viralSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001770-30-BE
• Lead Sponsor: CHU AMBROISE PARE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-15
• Last Update Posted: 10 August 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

- Positive COVID status as defined by:
PCR documented SARS-CoV-2 carriage in nasopharyngeal sample or evocative thoracic scan
images of COVID-19 associated with typical clinical presentation
- Hospitalized patients aged = 18 and = 75 years old
- Signs of severe COVID-19 pneumonia (3 of the followings)
- Patient wheezing or unable to speak in full sentences while at rest/with minimal
effort
- Respiratory rate >22
- PaO2 <65 mmHg or SpO2 <90%
- Repeated chest imaging is significantly worsening
despite being on standard of care, which may include anti-viral treatment, low dose steroids
and antibiotics.
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 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

- Immunosuppresion
- End stage renal failure and dialysis
- Life expectancy < 1 year (due to a condition other than COVID)
- Active neoplasia (treated or not)
- Breastfeeding and pregnant patients
- Known severe allergic reactions to TCZ or other monoclonal antibodies
- Non treated HIV infection, chronic B hepatitis, active C hepatitis, active tuberculosis
infection
- Have received oral anti-rejection or immunomodulatory drugs (including TCZ) with the past
6 months
- Participating in other drug clinical trials

Study & Design

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