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

COVID-19 Clinical Trial

— GETAFE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04361643
• Other study ID #: COVID19-EC01
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: October 27, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: April 2020
• Source: Hospital Universitario Getafe
• Contact: Joaquin De Haro, MD
• Phone: +34 626022977
• Email: deharojoaquin[@]yahoo.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Hospital Universitario de Getafe	Getafe

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario Getafe

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical improvement	Days to clinical recovery or days until discharge	30 days
Primary	Immune-inflammatory improvement	o Improvement of the neutrophil-to-lymphocyte ratio (NLR)	30 days
Secondary	Mortality	All-cause mortality at 30 days after enrollment	30 days