NCT04361643

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Hospital Universitario Getafe · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COVID-19

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2020-10-27
• Primary completion: 2021-08-31
• Completion: 2021-12-31
• First posted: 2020-04-24
• Last updated: 2020-07-31

Locations

1 site across 1 country: Spain