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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 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 |

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. |
- Clinical improvement [ Time Frame: 30 days ]Days to clinical recovery or days until discharge
- Immune-inflammatory improvement [ Time Frame: 30 days ]o Improvement of the neutrophil-to-lymphocyte ratio (NLR)
- Mortality [ Time Frame: 30 days ]All-cause mortality at 30 days after enrollment

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 60 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
Contact: Joaquin De Haro, MD | +34 626022977 | deharojoaquin@yahoo.es |
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 |
Study Chair: | Joaquin De Haro, MD | Hospital Universitario Getafe |
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 |
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 |
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 |