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

Hospital Universitario Getafe

Status and phase: Unknown; Phase 4

Conditions: COVID-19

Treatments: Drug: Placebo; Drug: Lenalidomide as a 5 mg capsule PO daily, days 1, 3, and 5.

Study type: Interventional

Funder types: Other

Identifiers

NCT04361643

COVID19-EC01

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups, including a placebo group

Experimental

Experimental group

Description:

Patients will receive Lenalidomide as a 5 mg capsule PO daily, days 1, 3, and 5.

Treatment:

Drug: Lenalidomide as a 5 mg capsule PO daily, days 1, 3, and 5.

Placebo

Placebo Comparator group

Description:

Patients will receive a placebo capsule PO daily, days 1, 3, and 5.

Treatment:

Drug: Placebo