Treatment of severe cases of Covid-19 with Eculizumab

Phase 1

Recruiting

• Conditions: Coronavirus disease; B34.2

• Registration Number: RBR-876qb5
• Lead Sponsor: Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-08
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

COVID-19 diagnosis confirmed by RT-PCR. Age between 18 and 80 years. Severe form of SARS-CoV-2 infection. ECOG prior to infection < ou igual a 2.

Exclusion Criteria

Age less than 18 years or more than 80 years. Known hypersensitivity and / or previous eculizumab therapy; septic shock and / or multiple organ failure syndrome; hstory of infection by human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C (HCV) (with the exception of chronic infections treated or cured for HBV and HCV, which will be accepted); neoplasms in activity or under treatment, except for basal cell carcinomas; any major surgery, extensive radiation therapy, delayed toxicity chemotherapy, biological therapy, or immunotherapy within 6 weeks prior to clinical trial screening; any investigational medication other than the study drugs in the 6 weeks before the first dose of the study drug; history of chronic liver disease (Child-Pugh B or C); hystory of chronic kidney disease (glomerular filtration rate <30 mL / min / 1.73 m²); any contraindication to the use of penicillin for bacterial meningitis's prophylaxis during the use of eculizumab; any contraindications to the use of contraceptive methods in childbearing age women.

Study & Design

• Study Type: Intervention
• Study Design: Not specified