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.
Drug: Lenalidomide 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.
Other Name: Revlimid
Drug: Placebo
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.
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.
Hospital Universitario de Getafe
Getafe, Spain
Investigator: Joaquin De Haro, MD,PhD
Contact: +34 916 839 360
deharojoaquin@yahoo.es
Investigator: Joaquin De Haro, MD,PhD
Joaquin De Haro, MD
+34 626022977
deharojoaquin@yahoo.es
Joaquin De Haro, MD, Study Chair
Hospital Universitario Getafe