Low-dose Lenalidomide for Non-severe COVID-19 Treatment Trial (GETAFE)

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

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.

Study Overview

• Status: Unknown
• Conditions: COVID-19
• Intervention / Treatment: Drug: Lenalidomide as a 5 mg capsule PO daily, days 1, 3, and 5.; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Getafe, Spain, 28905
    • Hospital Universitario de Getafe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 56 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.; 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 Names: Revlimid
Placebo Comparator: Placebo; Patients will receive a placebo capsule PO daily, days 1, 3, and 5.	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital Universitario Getafe
• Investigators: Study Chair: Joaquin De Haro, MD, Hospital Universitario Getafe

Study record dates

Study Major Dates

• Study Start (Anticipated): October 27, 2020
• Primary Completion (Anticipated): August 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: April 23, 2020
• First Submitted That Met QC Criteria: April 23, 2020
• First Posted (Actual): April 24, 2020

Study Record Updates

• Last Update Posted (Actual): July 31, 2020
• Last Update Submitted That Met QC Criteria: July 30, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Antineoplastic Agents; Immunologic Factors; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Lenalidomide
• Other Study ID Numbers: COVID19-EC01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No