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NCT04356690

Etoposide in Patients With COVID-19 Infection

Terminated Phase 2 Results posted Last updated 15 June 2023
What this trial tests

Phase 2 trial testing Etoposide in COVID-19 in 8 participants. Terminated before completion.

Timeline
8 May 2020
Primary endpoint
1 July 2022
1 July 2022

Quick facts

Lead sponsorBoston Medical Center
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposesupportive care
Enrollment8
Start date8 May 2020
Primary completion1 July 2022
Estimated completion1 July 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Boston Medical Center

Who can join

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

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Improvement in Pulmonary Status by Two Categories on an 8 Point Ordinal Scale of Respiratory Function Primary · baseline, through hospital discharge or death

8-Point Ordinal Scale of Respiratory Function: 8 -Death; 7 -Ventilation in addition to extracorporeal membrane oxygen (ECMO), continuous renal replacement therapy (CRRT), or need for vasopressors (dopamine ≥5 μg/kg/min OR epinephrine ≥0.1 μg/kg/min OR norepinephrine ≥0.1 μg/kg/min) 6 -Intubation and mechanical ventilation 5 -Non-invasive mechanical ventilation (NIV) or high-flow oxygen 4 -Hospitalized, requiring oxygen by mask or nasal prongs 3 -Hospitalization without oxygen supplementation 2-Discharged from hospital either to home with supplemental oxygen OR to inpatient rehabilitation/skill

GroupValue95% CI
Cohort 1 - Etoposide2
Cohort 1 - Control1
Overall Survival Secondary · 30 Days

Number of participants that lived to day 30 or hospital discharge

GroupValue95% CI
Cohort 1 - Etoposide3
Cohort 1 - Control1
Length of Hospitalization Secondary · From date of enrollment until date of discharge

Number of days participants were hospitalized after treatment

GroupValue95% CI
Cohort 1 - Etoposide17± 11.35
Cohort 1 - Control24± 5.66
Duration of Ventilation After Treatment Secondary · From date of enrollment until the date of extubation

Number of days participants were ventilated after treatment

GroupValue95% CI
Cohort 1 - Etoposide15.67± 12.9
Cohort 1 - Control15.0± 0
Change in Blood Ferritin Levels Secondary · baseline, to day 30 (or discharge or death)

Change in ferritin from treatment to day 30

GroupValue95% CI
Cohort 1 - Etoposide1235.67± 1180.59
Cohort 1 - Control-1771.50± 2320.02
Change in C-reactive Protein (CRP) Levels Secondary · baseline, to day 30 (or discharge or death)

Change in CRP levels from treatment to day 30

GroupValue95% CI
Cohort 1 - Etoposide-49.00± 64.38
Cohort 1 - Control-74.00± 63.64
Change in D-dimer Blood Levels Secondary · baseline, to day 30 (or discharge or death)

Change in d-dimer from treatment to day 30

GroupValue95% CI
Cohort 1 - Etoposide480.67± 2427.12
Cohort 1 - Control-2243.00± 3618.97
Change in White Blood Cell Count Secondary · baseline, to day 30 (or discharge or death)

Change in white blood cell count from treatment to day 30

GroupValue95% CI
Cohort 1 - Etoposide5.18± 6.35
Cohort 1 - Control13.40± 10.04
Change in Platelet Count Secondary · baseline, to day 30 (or discharge or death)

Change in platelet count from treatment to day 30

GroupValue95% CI
Cohort 1 - Etoposide-70.00± 100.84
Cohort 1 - Control102.00± 72.12

Adverse events — posted to ClinicalTrials.gov

Time frame: Treatment/enrollment until discharge or death. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cohort 1 - Etoposide
Serious: 1/6 (17%)
Deaths: 3/6
Cohort 1 - Control
Serious: 0/2 (0%)
Deaths: 1/2

Serious adverse events (1 terms)

ReactionSystemCohort 1 - EtoposideCohort 1 - Control
febrile neutropeniaInfections and infestations
Other adverse events (6 terms — click to expand)

ReactionSystemCohort 1 - EtoposideCohort 1 - Control
anemiaBlood and lymphatic system disorders
neutropeniaBlood and lymphatic system disorders
thrombocytopeniaBlood and lymphatic system disorders
Abnormal LFTsHepatobiliary disorders
acute kidney innuryRenal and urinary disorders
ventilatory asscociated pneumoniaInfections and infestations

Most-reported serious reactions: febrile neutropenia.

Data from ClinicalTrials.gov NCT04356690 adverse events section.

Sponsor's own description

This is a randomized, open-label phase II study designed to evaluate the safety and efficacy of etoposide in patients with the 2019 novel coronavirus (COVID-19) infection. Randomization will be performed with a 3:1 allocation ratio. Treatment will be comprised of etoposide administered intravenously at a dose of 150 mg/m2 on Days 1 and 4 in patients with COVID-19 infection meeting eligibility criteria. Subsequent doses of etoposide will be allowed if the investigator and treating physician believe the patient had clinical benefit from etoposide therapy but subsequently has evidence of recurrent clinical deterioration. Subjects randomized to control will receive standard of care treatment. No placebo will be used.

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. Races of small molecule clinical trials for the treatment of COVID-19: An up-to-date comprehensive review.
    Hu S, Jiang S, Qi X, Bai R, et al · · 2022 · cited 68× · PMID 34762760 · DOI 10.1002/ddr.21895
  3. 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
  4. 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
  5. Placental transfer and safety in pregnancy of medications under investigation to treat coronavirus disease 2019.
    Louchet M, Sibiude J, Peytavin G, Picone O, et al · · 2020 · cited 34× · PMID 32838264 · DOI 10.1016/j.ajogmf.2020.100159
  6. Learning through a Pandemic: The Current State of Knowledge on COVID-19 and Cancer.
    Elkrief A, Wu JT, Jani C, Enriquez KT, et al · · 2022 · cited 33× · PMID 34893494 · DOI 10.1158/2159-8290.cd-21-1368
  7. Primed for global coronavirus pandemic: Emerging research and clinical outcome.
    Ahamad S, Branch S, Harrelson S, Hussain MK, et al · · 2021 · cited 25× · PMID 33070079 · DOI 10.1016/j.ejmech.2020.112862
  8. Repurposing Anti-Cancer Drugs for COVID-19 Treatment.
    Borcherding N, Jethava Y, Vikas P. · · 2020 · cited 23× · PMID 33239864 · DOI 10.2147/dddt.s282252

Verify or expand the search:

Other trials of Etoposide

Trials testing the same drug.

Other recruiting trials for COVID-19

Currently open trials in the same condition.

Other Boston Medical Center trials

Trials by the same sponsor.

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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04356690.

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