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

Phase 4

• Conditions: COVID-19
• Interventions: Drug: Placebo; Drug: Lenalidomide as a 5 mg capsule PO daily, days 1, 3, and 5.

• Registration Number: NCT04361643
• Lead Sponsor: Hospital Universitario Getafe

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-04
• Study First Submitted: 2020-04-23
• Study First Submitted QC: 2020-04-23
• Study First Posted: 2020-04-24
• Last Update Submitted: 2020-07-30
• Last Update Posted: 2020-07-31
• Study Start: 2020-10-27
• Primary Completion: 2021-08-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Patients will receive a placebo capsule PO daily, days 1, 3, and 5.
Experimental	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Mortality	30 days	All-cause mortality at 30 days after enrollment

Trial Locations

Locations (1)

Hospital Universitario de Getafe; 🇪🇸 Getafe, Spain