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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04361643
Recruitment Status : Unknown
Verified April 2020 by Hospital Universitario Getafe.
Recruitment status was:  Not yet recruiting
First Posted : April 24, 2020
Last Update Posted : July 31, 2020
Sponsor:
Information provided by (Responsible Party):
Hospital Universitario Getafe

Study Description
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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.


Condition or disease Intervention/treatment Phase
COVID-19 Drug: Lenalidomide as a 5 mg capsule PO daily, days 1, 3, and 5. Drug: Placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-blind Randomized Controlled Clinical Trial of Low-dose Lenalidomide in the Treatment of COVID-19 Disease
Estimated Study Start Date : October 27, 2020
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Clinical improvement [ Time Frame: 30 days ]
    Days to clinical recovery or days until discharge

  2. Immune-inflammatory improvement [ Time Frame: 30 days ]
    o Improvement of the neutrophil-to-lymphocyte ratio (NLR)


Secondary Outcome Measures :
  1. Mortality [ Time Frame: 30 days ]
    All-cause mortality at 30 days after enrollment


Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04361643


Contacts
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Contact: Joaquin De Haro, MD +34 626022977 deharojoaquin@yahoo.es

Locations
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Spain
Hospital Universitario de Getafe
Getafe, Spain, 28905
Contact: Joaquin De Haro, MD,PhD    +34 916 839 360    deharojoaquin@yahoo.es   
Contact: Joaquin De Haro, MD, PhD    +34 916 839 360    deharojoaquin@yahoo.es   
Principal Investigator: Joaquin De Haro, MD,PhD         
Sponsors and Collaborators
Hospital Universitario Getafe
Investigators
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Study Chair: Joaquin De Haro, MD Hospital Universitario Getafe
More Information
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Responsible Party: Hospital Universitario Getafe
ClinicalTrials.gov Identifier: NCT04361643    
Other Study ID Numbers: COVID19-EC01
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: July 31, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
 Lung Diseases
Respiratory Tract Diseases
Lenalidomide
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents