COVID-19Phase 4GETAFENCT04361643
Low-dose Lenalidomide for Non-severe COVID-19 Treatment Trial
A Phase 4 study testing Lenalidomide as a 5 mg capsule PO daily, days 1, 3, and 5. in people with COVID-19, run by Hospital Universitario Getafe at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Lenalidomide as a 5 mg capsule PO daily, days 1, 3, and 5.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 27 Oct 2020to 31 Dec 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitario de Getafe
Getafe, 28905
Joaquin De Haro, MD,PhD, +34 916 839 360, deharojoaquin@yahoo.es
Joaquin De Haro, MD, PhD, +34 916 839 360, deharojoaquin@yahoo.es
About this study
Official title: Double-blind Randomized Controlled Clinical Trial of Low-dose Lenalidomide in the Treatment of COVID-19 Disease
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
- Being tested
- Lenalidomide as a 5 mg capsule PO daily, days 1, 3, and 5., Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lenalidomide as a 5 mg capsule PO daily, days 1, 3, and 5.Drug
Also called Revlimid
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Patients will receive Lenalidomide as a 5 mg capsule PO daily, days 1, 3, and 5. Receives: Drug: Lenalidomide as a 5 mg capsule PO daily, days 1, 3, and 5. |
| Placebo | Placebo comparator | Patients will receive a placebo capsule PO daily, days 1, 3, and 5. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical improvement
Days to clinical recovery or days until discharge
Measured: 30 days
Immune-inflammatory improvement
- Improvement of the neutrophil-to-lymphocyte ratio (NLR)
Measured: 30 days
Secondary outcomes (1)
Mortality
All-cause mortality at 30 days after enrollment
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start27 Oct 2020 (estimated)
- Primary completion31 Aug 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Getafe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joaquin De Haro, MD, Study chair, Hospital Universitario Getafe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04361643
- Sponsor's protocol ID
- COVID19-EC01
- Acronym
- GETAFE
- Status last verified
- Apr 2020
- First submitted
- 23 Apr 2020
- Last updated
- 31 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind Randomized Controlled Clinical Trial of Low-dose Lenalidomide in the Treatment of COVID-19 Disease
- ClinicalTrials.gov ID
- NCT04361643
- Acronym / sponsor ID
- GETAFE / COVID19-EC01
- Conditions
- COVID-19
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hospital Universitario GetafeUniversity, hospital or other
- Study start
- 27 Oct 2020 (estimated)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | 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. |
| Placebo | Placebo comparator | Drug: PlaceboPatients will receive a placebo capsule PO daily, days 1, 3, and 5. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lenalidomide as a 5 mg capsule PO daily, days 1, 3, and 5.Also: RevlimidPatients 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 | Experimental |
| PlaceboPatients 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. | Drug | Placebo |
Primary outcome
Clinical improvement
Time frame: 30 days
Days to clinical recovery or days until discharge
Immune-inflammatory improvement
Time frame: 30 days
o Improvement of the neutrophil-to-lymphocyte ratio (NLR)
1 secondary outcome
Mortality
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joaquin De Haro, MD study chair
Hospital Universitario Getafe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lenalidomide as a 5 mg capsule PO daily, days 1, 3, and 5. in people with COVID-19, run by Hospital Universitario Getafe at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joaquin De Haro, MD (+34 626022977, deharojoaquin@yahoo.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical improvement (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2020.