Status:
TERMINATED
Efficacy of Tocilizumab in Modifying the Inflammatory Parameters of Patients With COVID-19 (COVITOZ-01)
Lead Sponsor:
Hospital Universitario Ramon y Cajal
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
unicenter, randomized, open-label clinical trial on the efficacy of tocilizumab in modifying the inflammatory parameters of patients with COVID-19.
Detailed Description
National, unicenter, randomized, open-label, controlled phase II clinical trial with a drug marketed and administered under conditions of use other than those approved. The study is designed to evalu...
Eligibility Criteria
Inclusion
- Patients over 18 years of age who have given their informed consent. This will be collected verbally and will be recorded in the medical record by the investigating doctor.
- The patient is diagnosed with mild-moderate SARS-CoV-2 pneumonia confirmed microbiologically ≤7 days before randomization, and presents:
- to. Basal oxygen saturation\> 90% b. CURB-65 ≤1 c. PaO2 / FiO2≥300 or SatO2 / FiO2≥315
- The patient is hospitalized or meets hospital admission criteria.
- The patient is not expected to enter the ICU or die in the next 24 hours.
Exclusion
- Participants in another simultaneous clinical trial.
- Use of other immunomodulators.
- Coinfection with the hepatitis B virus (detectable AgSup-HBV).
- Pregnancy (or planning to become pregnant during the course of the study), or lactation period.
- Presence of laboratory abnormalities of grade ≥ 4.
Key Trial Info
Start Date :
May 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 10 2021
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT04435717
Start Date
May 4 2020
End Date
February 10 2021
Last Update
August 30 2021
Active Locations (1)
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1
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034