Low-dose Lenalidomide for Non-severe COVID-19 Treatment Trial
NCT ID: NCT04361643
Last Updated: 2020-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
120 participants
INTERVENTIONAL
2020-10-27
2021-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Experimental
Patients will receive Lenalidomide as a 5 mg capsule PO daily, days 1, 3, and 5.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
60 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hospital Universitario Getafe
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Joaquin De Haro, MD
Role: STUDY_CHAIR
Hospital Universitario Getafe
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital Universitario de Getafe
Getafe, , Spain
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Joaquin De Haro, MD,PhD
Role: primary
Joaquin De Haro, MD, PhD
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
COVID19-EC01
Identifier Type: -
Identifier Source: org_study_id