Status:
UNKNOWN
Clinical Trial to Evaluate Methylprednisolone Pulses and Tacrolimus in Patients With COVID-19 Lung Injury
Lead Sponsor:
Hospital Universitari de Bellvitge
Collaborating Sponsors:
Institut d'Investigació Biomèdica de Bellvitge
Conditions:
COVID-19
Lung Injury
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The primary objective of the study is to evaluate the days until reaching clinical stability after starting randomization in hospitalized patients with elevated inflammatory parameters and severe COVI...
Detailed Description
Unfortunately, the treatment of COVID-19 disease is still based on life support therapies. Nowadays, there is no scientific evidence from clinical trials regarding the efficacy or safety of different ...
Eligibility Criteria
Inclusion
- COVID-19 infection confirmed by PCR
- New onset radiological infiltrates
- Respiratory failure (PaO2 / FiO2 \<300 or satO2 / FiO2 \<220)
- PCR\>100 mg/L and/or D-Dimer\>1000 µg/L and/or Ferritin\>1000 ug/L
- Informed consent.
Exclusion
- Life expectancy ≤ 24h
- Glomerular filtration ≤ 30 ml / min / 1.73 m2
- Leukopenia ≤ 4000 cells / µL
- Concomitant potentially serious infections.
- Contraindication for the use of tacrolimus according to the specifications of the product
- Known adverse reactions to treatment
- Have participated in a clinical trial in the last 3 months
Key Trial Info
Start Date :
April 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2020
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT04341038
Start Date
April 1 2020
End Date
July 1 2020
Last Update
April 10 2020
Active Locations (1)
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1
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain, 08907