Status:
UNKNOWN
Low-dose Lenalidomide for Non-severe COVID-19 Treatment Trial
Lead Sponsor:
Hospital Universitario Getafe
Conditions:
COVID-19
Eligibility:
All Genders
60+ years
Phase:
PHASE4
Brief Summary
Double-blind randomized controlled clinical trial (RCT) of low-dose lenalidomide in the treatment of elderly patients (\> 60 years of age) with mild to moderate clinical signs of COVID-19 disease from...
Eligibility Criteria
Inclusion
- Subjects \> 60 years of age
- Diagnosed case (PCR test for COVID-19 if available) or COVID-19 clinical symptoms (defined as fever, dry cough, dyspnea, chest radiography with compatible findings with COVID-19)
- Lymphocyte count ≥ 0.2 x 103/µL and ≤1.0 x 103/µL.
- Neutrophil count ≥ 1.8 x 103/µL, platelets ≥ 150 x 103/µL.
- ROX ≥ 10 index
- Signed informed consent document
- Willing to comply with the lenalidomide Risk Minimization Program (Pregnancy Prevention Program approved)
Exclusion
- Absolute contraindication of lenalidomide use or hypersensitivity to the active ingredient or any of the excipients.
- Active neoplasia
- Previous autoimmune disease
- Concurrent infection of HBV, HCV or tuberculosis.
- Aspartate transaminase (AST) or alanine transaminase (ALT) \> 3 times the upper limit of normal (ULN).
- Bilirubin levels \> 1.5 times the ULN
- Renal impairment with an estimated GF \< 30ml/min
- Venous thromboembolism events within the previous 3 years
- Significant active heart disease within the previous 6 months, including congestive heart failure (class II-IV NYHA), unstable angina or myocardial infarctions
- Sexually active subjects who refuse the lenalidomide Risk Minimization Program
- Inability to comply with the working protocol under the responsible health professional opinion.
Key Trial Info
Start Date :
October 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04361643
Start Date
October 27 2020
End Date
December 31 2021
Last Update
July 31 2020
Active Locations (1)
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1
Hospital Universitario de Getafe
Getafe, Spain, 28905