Low-dose Lenalidomide for Non-severe COVID-19 Treatment Trial

Study Overview
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Brief Summary
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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.

Official Title
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Double-blind Randomized Controlled Clinical Trial of Low-dose Lenalidomide in the Treatment of COVID-19 Disease

Conditions
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COVID-19

Intervention / Treatment
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* Drug: Lenalidomide as a 5 mg capsule PO daily, days 1, 3, and 5.
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Patients will receive Lenalidomide as a 5 mg capsule PO daily, days 1, 3, and 5. | Drug: Lenalidomide as a 5 mg capsule PO daily, days 1, 3, and 5.<br>* 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.<br>* Other names: Revlimid;|
| Placebo Comparator: Placebo<br>Patients will receive a placebo capsule PO daily, days 1, 3, and 5. | Drug: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical improvement | Days to clinical recovery or days until discharge | 30 days | 
| Immune-inflammatory improvement | o Improvement of the neutrophil-to-lymphocyte ratio (NLR) | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | All-cause mortality at 30 days after enrollment | 30 days |