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

• Status: Not yet recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Universitario Getafe
• Treatments: Lenalidomide

Criteria

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.