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

NCT04361643 | Unknown Phase 4

• 1 other identifier: COVID19-EC01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Mortality

  30 days

Study Arms (2)

Experimental

EXPERIMENTAL

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.

Placebo

PLACEBO COMPARATOR

Patients will receive a placebo capsule PO daily, days 1, 3, and 5.

Drug: Placebo

Interventions

Lenalidomide as a 5 mg capsule PO daily, days 1, 3, and 5. DRUG

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.

Also known as: Revlimid

Experimental

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario Getafe: lead

Study Sites (1)

Hospital Universitario de Getafe

Getafe, 28905, Spain

Location

MeSH Terms

Conditions

COVID-19

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Joaquin De Haro, MD

  Hospital Universitario Getafe

  STUDY CHAIR

Central Study Contacts

Joaquin De Haro, MD

CONTACT

+34 626022977; deharojoaquin@yahoo.es

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2020
• First Posted: April 24, 2020
• Study Start: October 27, 2020
• Primary Completion: August 31, 2021
• Study Completion: December 31, 2021
• Last Updated: July 31, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)