COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04361643

Joaquin De Haro, MD

deharojoaquin@yahoo.es

2020-04-24

Not reported

RCT

Randomized

Parallel

Blind label

single-center

Treatment

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)

- 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.

2

Hospital Universitario Getafe

60

None

Spain

Moderate disease at enrollment

3: Moderate disease at enrollment

120

Immune-inflammatory improvement;Clinical improvement

None

Phase 4

[{"arm_notes": "", "treatment_id": 725, "treatment_name": "Lenalidomide", "treatment_type": "Immunosuppressants", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]