COVID-19
Conditions
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 the Hospital Universitario of Getafe. The study will include patients of both sexes (\> 60 years of age) with mild to moderate clinical presentation of COVID-19 (ROX index \> 10). Subjects will be randomly assigned to the experimental arm with lenalidomide (5 mg/24h, day 1, 3 and 5) or to the controlled arm. Other concomitant medication for the treatment of COVID-19 will be also considered.
Interventions
DRUGLenalidomide as a 5 mg capsule PO daily, days 1, 3, and 5.
Patients will receive Lenalidomide as a 5 mg capsule PO daily, days 1, 3 and 5, together with a prophylactic dose of low molecular weight heparin (LMWH) or therapeutic dose if needed due to previous comorbidity.
DRUGPlacebo
Patients will receive a placebo capsule PO daily, days 1, 3 and 5, together with a prophylactic dose of low molecular weight heparin (LMWH) or therapeutic dose if needed due to previous comorbidity.
Sponsors
Hospital Universitario Getafe
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical improvement | 30 days | Days to clinical recovery or days until discharge |
| Immune-inflammatory improvement | 30 days | o Improvement of the neutrophil-to-lymphocyte ratio (NLR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 30 days | All-cause mortality at 30 days after enrollment |
Countries
Spain
Contacts
Primary ContactJoaquin De Haro, MD
Outcome results
None listed