NCT04361643: GETAFE

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

Status unknown Phase 4 Last updated 31 July 2020

What this trial tests

Phase 4 trial testing Lenalidomide as a 5 mg capsule PO daily, days 1, 3, and 5. in COVID-19 in 120 participants. Status unknown.

Timeline

27 October 2020

Primary endpoint
31 August 2021

31 December 2021

Quick facts

Lead sponsor	Hospital Universitario Getafe
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	120
Start date	27 October 2020
Primary completion	31 August 2021
Estimated completion	31 December 2021
Sites	1 location across Spain

Drugs / interventions tested

• Lenalidomide as a 5 mg capsule PO daily, days 1, 3, and 5. — full drug profile →
• Placebo

Conditions studied

• COVID-19 — all drugs for COVID-19 →

Sponsor

Hospital Universitario Getafe

Who can join

60 and older, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Contribution of monocytes and macrophages to the local tissue inflammation and cytokine storm in COVID-19: Lessons from SARS and MERS, and potential therapeutic interventions.
   Jafarzadeh A, Chauhan P, Saha B, Jafarzadeh S, et al · · 2020 · cited 246× · PMID 32687918 · DOI 10.1016/j.lfs.2020.118102
2. An update on drugs with therapeutic potential for SARS-CoV-2 (COVID-19) treatment.
   Drożdżal S, Rosik J, Lechowicz K, Machaj F, et al · · 2021 · cited 186× · PMID 34991982 · DOI 10.1016/j.drup.2021.100794
3. Comprehensive analysis of drugs to treat SARS‑CoV‑2 infection: Mechanistic insights into current COVID‑19 therapies (Review).
   Nitulescu GM, Paunescu H, Moschos SA, Petrakis D, et al · · 2020 · cited 93× · PMID 32468014 · DOI 10.3892/ijmm.2020.4608
4. Potential therapeutic targets for combating SARS-CoV-2: Drug repurposing, clinical trials and recent advancements.
   Pandey A, Nikam AN, Shreya AB, Mutalik SP, et al · · 2020 · cited 80× · PMID 32497632 · DOI 10.1016/j.lfs.2020.117883
5. COVID-19 and Cancer Comorbidity: Therapeutic Opportunities and Challenges.
   Pathania AS, Prathipati P, Abdul BA, Chava S, et al · · 2021 · cited 71× · PMID 33391502 · DOI 10.7150/thno.51471
6. Neuropathophysiology of coronavirus disease 2019: neuroinflammation and blood brain barrier disruption are critical pathophysiological processes that contribute to the clinical symptoms of SARS-CoV-2 infection.
   Welcome MO, Mastorakis NE. · · 2021 · cited 50× · PMID 33822324 · DOI 10.1007/s10787-021-00806-x
7. Repurposing anticancer drugs for COVID-19-induced inflammation, immune dysfunction, and coagulopathy.
   Saini KS, Lanza C, Romano M, de Azambuja E, et al · · 2020 · cited 38× · PMID 32572174 · DOI 10.1038/s41416-020-0948-x
8. Novel therapeutic approaches for treatment of COVID-19.
   Hossein-Khannazer N, Shokoohian B, Shpichka A, Aghdaei HA, et al · · 2020 · cited 36× · PMID 32494931 · DOI 10.1007/s00109-020-01927-6