Low-dose Lenalidomide for Non-severe COVID-19 Treatment Trial (GETAFE)
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|ClinicalTrials.gov Identifier: NCT04361643|
Recruitment Status : Not yet recruiting
First Posted : April 24, 2020
Last Update Posted : July 31, 2020
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
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
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 firstname.lastname@example.org|
|Study Chair:||Joaquin De Haro, MD||Hospital Universitario Getafe|