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

Primary Purpose

COVID-19

Status
Unknown status
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Lenalidomide as a 5 mg capsule PO daily, days 1, 3, and 5.
Placebo
Sponsored by
Hospital Universitario Getafe
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Universitario de Getafe

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental

Placebo

Arm Description

Patients will receive Lenalidomide as a 5 mg capsule PO daily, days 1, 3, and 5.

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

Outcomes

Primary Outcome Measures

Clinical improvement
Days to clinical recovery or days until discharge
Immune-inflammatory improvement
o Improvement of the neutrophil-to-lymphocyte ratio (NLR)

Secondary Outcome Measures

Mortality
All-cause mortality at 30 days after enrollment

Full Information

First Posted
April 23, 2020
Last Updated
July 30, 2020
Sponsor
Hospital Universitario Getafe
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1. Study Identification

Unique Protocol Identification Number
NCT04361643
Brief Title
Low-dose Lenalidomide for Non-severe COVID-19 Treatment Trial
Acronym
GETAFE
Official Title
Double-blind Randomized Controlled Clinical Trial of Low-dose Lenalidomide in the Treatment of COVID-19 Disease
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 27, 2020 (Anticipated)
Primary Completion Date
August 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Universitario Getafe

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
Patients will receive Lenalidomide as a 5 mg capsule PO daily, days 1, 3, and 5.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients will receive a placebo capsule PO daily, days 1, 3, and 5.
Intervention Type
Drug
Intervention Name(s)
Lenalidomide as a 5 mg capsule PO daily, days 1, 3, and 5.
Other Intervention Name(s)
Revlimid
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical improvement
Description
Days to clinical recovery or days until discharge
Time Frame
30 days
Title
Immune-inflammatory improvement
Description
o Improvement of the neutrophil-to-lymphocyte ratio (NLR)
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Mortality
Description
All-cause mortality at 30 days after enrollment
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joaquin De Haro, MD
Phone
+34 626022977
Email
deharojoaquin@yahoo.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joaquin De Haro, MD
Organizational Affiliation
Hospital Universitario Getafe
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Universitario de Getafe
City
Getafe
ZIP/Postal Code
28905
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joaquin De Haro, MD,PhD
Phone
+34 916 839 360
Email
deharojoaquin@yahoo.es
First Name & Middle Initial & Last Name & Degree
Joaquin De Haro, MD, PhD
Phone
+34 916 839 360
Email
deharojoaquin@yahoo.es
First Name & Middle Initial & Last Name & Degree
Joaquin De Haro, MD,PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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