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History of Changes for Study: NCT04784559
Trial to Determine the Efficacy/Safety of Plitidepsin vs Control in Patients With Moderate COVID-19 Infection (Neptuno)
Latest version (submitted October 24, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 March 4, 2021 None (earliest Version on record)
2 March 5, 2021 Study Status and Study Identification
3 June 4, 2021 Recruitment Status, Contacts/Locations, Outcome Measures, Study Status, Eligibility, Arms and Interventions, Oversight and Study Identification
4 June 18, 2021 Contacts/Locations and Study Status
5 July 7, 2021 Contacts/Locations and Study Status
6 July 23, 2021 Contacts/Locations and Study Status
7 August 2, 2021 Contacts/Locations and Study Status
8 August 18, 2021 Contacts/Locations and Study Status
9 August 31, 2021 Contacts/Locations and Study Status
10 September 20, 2021 Outcome Measures, Arms and Interventions, Study Status, Contacts/Locations and Eligibility
11 October 8, 2021 Contacts/Locations and Study Status
12 October 27, 2021 Contacts/Locations and Study Status
13 November 19, 2021 Contacts/Locations and Study Status
14 December 15, 2021 Contacts/Locations and Study Status
15 January 10, 2022 Contacts/Locations and Study Status
16 January 25, 2022 Contacts/Locations and Study Status
17 February 8, 2022 Contacts/Locations and Study Status
18 February 23, 2022 Study Status and Contacts/Locations
19 March 11, 2022 Study Status and Contacts/Locations
20 March 31, 2022 Contacts/Locations and Study Status
21 April 20, 2022 Study Status and Contacts/Locations
22 May 6, 2022 Contacts/Locations and Study Status
23 June 22, 2022 Outcome Measures, Contacts/Locations, Arms and Interventions, Study Status and Eligibility
24 July 6, 2022 Contacts/Locations and Study Status
25 July 20, 2022 Study Status and Contacts/Locations
26 August 3, 2022 Study Status and Contacts/Locations
27 August 30, 2022 Contacts/Locations and Study Status
28 September 26, 2022 Contacts/Locations and Study Status
29 October 13, 2022 Contacts/Locations and Study Status
30 October 24, 2022 Study Status and Contacts/Locations
Comparison Format:

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Changes (Merged) for Study: NCT04784559
February 8, 2022 (v17) -- February 23, 2022 (v18)

Changes in: Study Status and Contacts/Locations

Open or close this module Study Identification
Unique Protocol ID: APL-D-003-20
Brief Title: Trial to Determine the Efficacy/Safety of Plitidepsin vs Control in Patients With Moderate COVID-19 Infection (Neptuno)
Official Title: A Phase 3, Multicentre, Randomised, Controlled Trial to Determine the Efficacy and Safety of Two Dose Levels of Plitidepsin Versus Control in Adult Patient Requiring Hospitalisation for Management of Moderate COVID-19 Infection
Secondary IDs: 2020-005951-19 [EudraCT Number]
Open or close this module Study Status
Record Verification: February 2022
Overall Status: Recruiting
Study Start: June 4, 2021
Primary Completion: March December 2022 [Anticipated]
Study Completion: March December 2022 [Anticipated]
First Submitted: March 4, 2021
First Submitted that
Met QC Criteria:
March 4, 2021
First Posted: March 5, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:
February 8 23, 2022
Last Update Posted: February 9 24, 2022 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: PharmaMar
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: Treatment of patients hospitalised for management of moderate COVID-19 infection
Detailed Description: This is a multicentre, open-label, controlled Phase 3 study in which adults requiring hospital admission and O2 supplementation for management of moderate COVID-19 infection will be randomised in 1:1:1 to: Plitidepsin 1.5 mg arm, Plitidepsin 2.5 mg arm and Control arm
Open or close this module Conditions
Conditions: COVID-19 Infection
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Patients Will be randomised in 1:1:1 to: Plitidepsin 1.5 mg arm, Plitidepsin 2.5 mg arm and Control arm
Number of Arms: 3
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 609 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Plitidepsin 1.5 mg arm

Patients will receive plitidepsin 1.5 mg/day intravenous (IV) combined with dexamethasone phosphate 8 mg/day (equivalent to 6.6 mg dexamethasone base) IV on Days 1 to 3, followed by dexamethasone phosphate 7.2 mg (equivalent to 6 mg/day dexamethasone base) oral administration (PO)/IV from Day 4 and up to a total cumulative dose of 60 mg of dexamethasone base (as per physician judgement according to patient clinical condition and evolution).

The study allows up to a total cumulative dose of 60 mg of dexamethasone base (calculation of the total dose will also include corticosteroids administered within 72 hours before the start of the study treatment and dexamethasone administered as premedication).

Drug: Plitidepsin

Plitidepsin 2 mg powder is provided as a sterile, preservative-free, and white to off-white lyophilised powder/cake comprising 2 mg plitidepsin and 100 mg mannitol in a single-dose, 10 mL clear type 1 glass vial.

Solvent for plitidepsin is provided as a sterile, preservative-free, clear, slightly viscous aqueous liquid (4 mL) containing 0.15 mL macrogolglycerol ricinoleate and 0.15 mL/mL ethanol in a single-dose type 1 clear glass ampoule.

For administration, vial contents are reconstituted by addition of 4 mL of solvent for plitidepsin to obtain a slightly yellowish solution containing 0.5 mg/mL plitidepsin with mannitol, macrogolglycerol ricinoleate and ethanol excipients. The required amount of plitidepsin reconstituted solution is added to an IV bag containing 0.9% sodium chloride injection or 5% glucose for injection and administered as an intravenous infusion over 60 minutes.

Drug: Dexamethasone
Detailed information about the formulation, packaging and labelling, storage, and manufacturer is provided in the current country-specific product information. The summary of product characteristics (SmPC) and/or leaflet provides detailed product information for investigators in the European Union and/or in other regions.
Experimental: Plitidepsin 2.5 mg arm

Patients will receive plitidepsin 2.5 mg/day intravenous (IV) combined with dexamethasone phosphate 8 mg/day (equivalent to 6.6 mg dexamethasone base) IV on Days 1 to 3, followed by dexamethasone phosphate 7.2 mg (equivalent to 6 mg/day dexamethasone base) from Day 4 and up to a total cumulative dose of 60 mg of dexamethasone base (as per physician judgement according to patient clinical condition and evolution).

The study allows up to a total cumulative dose of 60 mg of dexamethasone base (calculation of the total dose will also include corticosteroids administered within 72 hours before the start of the study treatment and dexamethasone administered as premedication).

Drug: Plitidepsin

Plitidepsin 2 mg powder is provided as a sterile, preservative-free, and white to off-white lyophilised powder/cake comprising 2 mg plitidepsin and 100 mg mannitol in a single-dose, 10 mL clear type 1 glass vial.

Solvent for plitidepsin is provided as a sterile, preservative-free, clear, slightly viscous aqueous liquid (4 mL) containing 0.15 mL macrogolglycerol ricinoleate and 0.15 mL/mL ethanol in a single-dose type 1 clear glass ampoule.

For administration, vial contents are reconstituted by addition of 4 mL of solvent for plitidepsin to obtain a slightly yellowish solution containing 0.5 mg/mL plitidepsin with mannitol, macrogolglycerol ricinoleate and ethanol excipients. The required amount of plitidepsin reconstituted solution is added to an IV bag containing 0.9% sodium chloride injection or 5% glucose for injection and administered as an intravenous infusion over 60 minutes.

Drug: Dexamethasone
Detailed information about the formulation, packaging and labelling, storage, and manufacturer is provided in the current country-specific product information. The summary of product characteristics (SmPC) and/or leaflet provides detailed product information for investigators in the European Union and/or in other regions.
Active Comparator: Control arm

Dexamethasone phosphate 8 mg/day (equivalent to 6.6 mg dexamethasone base) IV on Days 1 to 3, followed by dexamethasone phosphate 7.2 mg (equivalent to 6 mg/day dexamethasone base) from Day 4 and up to a total cumulative dose of 60 mg of dexamethasone base (as per physician judgement according to patient clinical condition and evolution). Per local treatment guidelines, patients may receive a regulatory approved antiviral treatment, such as remdesivir (200 mg IV on Day 1 followed by 100 mg/day IV on Days 2 to 5) or favipiravir (1600 mg twice daily [BID] PO on Day 1, followed by 600 mg BID PO daily for 2 to 5 days). Antiviral to be used per approved product information in each country, different dosages could be used.

The study allows up to a total cumulative dose of 60 mg of dexamethasone base (calculation of the total dose will also include corticosteroids administered within 72 hours before the start of the study treatment and dexamethasone administered as premedication).

Drug: Dexamethasone
Detailed information about the formulation, packaging and labelling, storage, and manufacturer is provided in the current country-specific product information. The summary of product characteristics (SmPC) and/or leaflet provides detailed product information for investigators in the European Union and/or in other regions.
Drug: Remdesivir
Detailed information about the formulation, packaging and labelling, storage, and manufacturer is provided in the current country-specific product information. The summary of product characteristics (SmPC) and/or leaflet provides detailed product information for investigators in the European Union and/or in other regions.
Drug: Favipiravir
Detailed information about the formulation, packaging and labelling, storage, and manufacturer is provided in the current country-specific product information. The summary of product characteristics (SmPC) and/or leaflet provides detailed product information for investigators in the European Union and/or in other regions.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Percentage of patients who achieve complete recovery:
[ Time Frame: Day 8 (±1) ]

(i) meeting categories 0 to 2 on 11-point World Health Organization (WHO) Clinical Progression Scale, (ii) Barthel Index >90/100 at the time of discharge, and (iii) with no re-admission for COVID-19-related signs or symptoms through Day 31.

11-category WHO Clinical Progression Scale: 0. uninfected, no viral RNA detected; 1. asymptomatic, viral RNA detected and 2; symptomatic, independent

Secondary Outcome Measures:
1. Time to complete recovery
[ Time Frame: From administration date to Day 31 ]

2. Clinical status assessed by 11-category WHO Clinical Progression Scale:
[ Time Frame: Once daily while the patient is hospitalized, Day 8 (±1), 4, 15, 31 ]

0: uninfected, no viral RNA detected

  1. asymptomatic, viral RNA detected
  2. symptomatic, independent
  3. symptomatic, assistance needed
  4. hospitalised, no oxygen therapy (if hospitalised for isolation only, record status as for ambulatory patient)
  5. hospitalised, oxygen by mask or nasal prongs
  6. hospitalised, oxygen by noninvasive ventilation (NIV) or high flow
  7. intubation and mechanical ventilation. pO2/FIO2 ≥150 or SpO2/FIO2 ≥200
  8. mechanical ventilation pO2/FIO2 <150 (SpO2/FIO2 <200) or vasopressors
  9. mechanical ventilation pO2/FIO2 <150 and vasopressors, dialysis, or ECMO
  10. dead
3. Proportion of patients with treatment-emergent adverse events (TEAEs)
[ Time Frame: From administration date to Day 31 ]

4. Proportion of patients with Grade ≥3 TEAEs
[ Time Frame: From administration date to Day 31 ]

5. Proportion of patients with serious adverse events (SAEs)
[ Time Frame: From administration date to Day 31 ]

6. Proportion of patients with serious adverse reactions (SARs)
[ Time Frame: From administration date to Day 31 ]

7. Proportion of patients with adverse events (AEs) of special interest
[ Time Frame: From administration date to Day 31 ]

8. Number and severity of treatment emergent adverse events as per National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 criteria (CTCAE v5.0)
[ Time Frame: From administration date to Day 31 ]

9. Proportion of patients requiring re-admission for COVID-19 signs or symptoms
[ Time Frame: From administration date to Day 31 ]

10. Duration of oxygen therapy (in days)
[ Time Frame: From administration date to day 31 ]

11. Proportion of patients requiring high-flow oxygen
[ Time Frame: Days 4, 8, 15, and 31 ]

12. Proportion of patients requiring noninvasive mechanical ventilation
[ Time Frame: Days 4, 8, 15, and 31 ]

13. Proportion of patients requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
[ Time Frame: Days 4, 8, 15, and 31 ]

14. Proportion of patients requiring admission to Intensive Care Unit (ICU)
[ Time Frame: Days 4, 8, 15, and 31 ]

15. Duration of hospitalization in ICU
[ Time Frame: From administration date to Day 31 ]

16. Proportion of patients receiving subsequent antiviral therapies or immunomodulatory drugs
[ Time Frame: Days 4, 8, 15, and 31 ]

17. Proportion of patients with nosocomial infection
[ Time Frame: From administration date to Day 31 ]

18. Mortality
[ Time Frame: Days 4, 8, 15, and 31 ]

19. Change in SARS-CoV-2 viral, as measured by quantitative polymerase chain reaction (qPCR) from samples of oro-nasopharyngeal exudate
[ Time Frame: Day 8(+/- 1) ]

20. Proportion of patients with undetectable SARS-CoV-2 viral load, as measured by qPCR from samples of oro-nasopharyngeal exudate
[ Time Frame: Day 8(+/- 1) ]

21. Change in inflammatory biomarker: C-reactive protein (CRP)
[ Time Frame: Days 1, 2, 3, 4, 8, and 31 ]

22. Change in inflammatory biomarker: ferritin
[ Time Frame: Days 1, 2, 3, 4, 8, and 31 ]

23. Change in inflammatory biomarker: IL-6, IL-1β, IL-10
[ Time Frame: Days 1, 2, 3, 4, 8, and 31 ]

24. Change in inflammatory biomarker: tumour necrosis factor alpha (TNFα)
[ Time Frame: Days 1, 2, 3, 4, 8, and 31 ]

25. Proportion of patients with serologic response anti-SARS-CoV-2
[ Time Frame: Day 1 and 31 ]

26. Time to therapy intensification (WHO >6 [intubation] or initiation of other antiviral/immunomodulating agent)
[ Time Frame: From administration date to Day 31 ]

27. Percentage of patients requiring increased oxygen therapy on study
[ Time Frame: From administration date to Day 31 ]

Other Outcome Measures:
1. Incidence of treatment emergent adverse events (TEAEs), Grade ≥3 TEAEs, serious adverse events (SAEs), deaths, TEAEs leading to premature discontinuation of study drug and adverse events (AEs) of special interest
[ Time Frame: From administration date to Day 31 ]

2. Change from baseline in clinical chemistry parameter: alanine transaminase (ALT) [U/L]
[ Time Frame: Screening (Day 0-1), Days 1, 2, 3, 4, 8, and 31 ]

3. Change from baseline in clinical chemistry parameter: aspartate transaminase (AST) [U/L]
[ Time Frame: Screening (Day 0-1), Days 1, 2, 3, 4, 8, and 31 ]

4. Change from baseline in clinical chemistry parameter: alkaline phosphatase [U/L]
[ Time Frame: Days 1, 2, 3, 4, 8, and 31 ]

5. Change from baseline in clinical chemistry parameter: gamma glutamyl transferase (GGT) [U/L]
[ Time Frame: Screening (Day 0-1), Days 1, 2, 3, 4, 8, and 31 ]

6. Change from baseline in clinical chemistry parameter: lactate dehydrogenase (LDH) [U/L]
[ Time Frame: Screening (Day 0-1), Days 1, 2, 3, 4, 8, and 31 ]

7. Change from baseline in clinical chemistry parameter: total bilirubin [mg/dL]
[ Time Frame: Screening (Day 0-1), Days 1, 2, 3, 4, 8, and 31 ]

8. Change from baseline in clinical chemistry parameter: direct bilirubin [mg/dL]
[ Time Frame: Screening (Day 0-1), Days 1, 2, 3, 4, 8, and 31 ]

9. Change from baseline in clinical chemistry parameter: lipase [U/L]
[ Time Frame: Screening (Day 0-1), Days 1, 2, 3, 4, 8, and 31 ]

10. Change from baseline in clinical chemistry parameter: amylase [U/L]
[ Time Frame: Screening (Day 0-1), Days 1, 2, 3, 4, 8, and 31 ]

11. Change from baseline in clinical chemistry parameter: glucose (fasting) (mg/dL)
[ Time Frame: Screening (Day 0-1), Days 1, 2, 3, 4, 8, and 31 ]

12. Change from baseline in clinical chemistry parameter: sodium [mEq/L]
[ Time Frame: Screening (Day 0-1), Days 1, 2, 3, 4, 8, and 31 ]

13. Change from baseline in clinical chemistry parameter: potassium [mEq/L]
[ Time Frame: Screening (Day 0-1), Days 1, 2, 3, 4, 8, and 31 ]

14. Change from baseline in clinical chemistry parameter: calcium (albumin adjusted calculation) [mEq/L]
[ Time Frame: Screening (Day 0-1), Days 1, 2, 3, 4, 8, and 31 ]

15. Change from baseline in clinical chemistry parameter: magnesium [mEq/L]
[ Time Frame: Screening (Day 0-1), Days 1, 2, 3, 4, 8, and 31 ]

16. Change from baseline in clinical chemistry parameter: blood urea nitrogen (BUN) [mg/dL]
[ Time Frame: Screening (Day 0-1), Days 1, 2, 3, 4, 8, and 31 ]

17. Change from baseline in clinical chemistry parameter: creatinine [mg/dL]
[ Time Frame: Screening (Day 0-1), Days 1, 2, 3, 4, 8, and 31 ]

18. Change from baseline in clinical chemistry parameter: calculated creatinine clearance (Cockcroft-Gault equation) [ml/min]
[ Time Frame: Screening (Day 0-1), Days 1, 2, 3, 4, 8, and 31 ]

19. Change from baseline in clinical chemistry parameter: albumin [g/dL]
[ Time Frame: Screening (Day 0-1), Days 1, 2, 3, 4, 8, and 31 ]

20. Change from baseline in clinical chemistry parameter: creatine-phosphokinase (CPK) [U/L]
[ Time Frame: Screening (Day 0-1), Days 1, 2, 3, 4, 8, and 31 ]

21. Change from baseline in Troponin (I or T according to local practice for screening)
[ Time Frame: Screening (Day 0-1), Days 1, 2, 3, 4, 8, and 31 ]

22. Change from baseline in Troponin T (high sensitivity)
[ Time Frame: Screening (Day 0-1), Days 1, 8, and 31 ]

23. Change from baseline in N-terminal pro b-type natriuretic peptide (NT-pro BNP)
[ Time Frame: Screening (Day 0-1), Days 1, 8, and 31 ]

24. Change from baseline in Procalcitonin
[ Time Frame: Screening (Day 0-1), Days 1, 2, 3, 4, 8, and 31 ]

25. Change from baseline in coagulation: D dimer
[ Time Frame: Days 1, 2, 3, 4, 8, and 31 ]

26. Change from baseline in serological SARS CoV 2 testing: immunoglobulin [Ig]G)
[ Time Frame: Day 1 and 31(+/- 3) ]

27. Change from baseline in hematology laboratory parameter: red blood cell (RBC) [cells10^6/µL]
[ Time Frame: Screening (Day 0-1), Days 1, 2, 3, 4, 8, and 31 ]

28. Change from baseline in hematology laboratory parameter: haemoglobin [g/dL]
[ Time Frame: Screening (Day 0-1), Days 1, 2, 3, 4, 8, and 31 ]

29. Change from baseline in hematology laboratory parameter: haematocrit [%]
[ Time Frame: Screening (Day 0-1), Days 1, 2, 3, 4, 8, and 31 ]

30. Change from baseline in hematology laboratory parameter: white blood cell (WBC) with differential [cells10^3/µL]
[ Time Frame: Screening (Day 0-1), Days 1, 2, 3, 4, 8, and 31 ]

31. Change from baseline in hematology laboratory parameter: platelet count [cells10^3/µL]
[ Time Frame: Screening (Day 0-1), Days 1, 2, 3, 4, 8, and 31 ]

32. Change from baseline in vital sign: temperature [°C or °F]
[ Time Frame: Screening (Day 0-1), Once daily while the patient is hospitalized, and on Days 8 and 31 ]

33. Change from baseline in vital sign: sitting blood pressure [mmHg]
[ Time Frame: Screening (Day 0-1), Once daily while the patient is hospitalized, and on Days 8 and 31 ]

34. Change from baseline in vital sign: heart rate [beats per minute]
[ Time Frame: Screening (Day 0-1), Once daily while the patient is hospitalized, and on Days 8 and 31 ]

35. Change from baseline in vital sign: respiratory rate [breaths per minute]
[ Time Frame: Screening (Day 0-1), Once daily while the patient is hospitalized, and on Days 8 and 31 ]

36. Change from baseline in vital sign: saturation of oxygen (SpO2) at room air [%]by pulse oximetry or arterial blood gas analyses and its respective FiO2 [%]
[ Time Frame: Screening (Day 0-1), Once daily while the patient is hospitalized, and on Days 8 and 31 ]

37. Change from baseline in electrocardiogram (ECG) findings: QTcF prolongation
[ Time Frame: Screening (Day 0-1), Day, 1, Day 3 (postinfusion) and Day 31 ]

38. Change from baseline in electrocardiogram (ECG) findings: any QTcF values >500 msec
[ Time Frame: Screening (Day 0-1), Day, 1, Day 3 (postinfusion) and Day 31 ]

39. Change from baseline in electrocardiogram (ECG) findings: QTcF interval >30 msec
[ Time Frame: Screening (Day 0-1), Day, 1, Day 3 (postinfusion) and Day 31 ]

40. Substudy only: Change from baseline in electrocardiogram (ECG) findings: heart rate
[ Time Frame: 0, 1, 2.5, 5, 24, 25, 26.5, 29, 48, and 49 hours ]

41. Substudy only: Change from baseline in ECG findings: QTc
[ Time Frame: 0, 1, 2.5, 5, 24, 25, 26.5, 29, 48 and 49 hours ]

42. Substudy only: Change from baseline in ECG findings: QRS
[ Time Frame: 0, 1, 2.5, 5, 24, 25, 26.5, 29, 48, and 49 hours ]

43. Substudy only: Change from baseline in ECG findings: waveform morphology-related measurements
[ Time Frame: 0, 1, 2.5, 5, 24, 25, 26.5, 29, 48, and 49 hours ]

44. Substudy only: Change from baseline in ECG findings: QTc for whole blood concentrations of plitidepsin (ng/ml)
[ Time Frame: 0, 1, 2.5, 5, 24, 25, 26.5, 29, 48, and 49 hours ]

45. Substudy only: Whole blood clearance of plitidepsin
[ Time Frame: 0, 1, 2.5, 5, 24, 25, 26.5, 29, 48, 49 and 72 hours ]

46. Substudy only: Whole blood area under curve (AUC) of plitidepsin
[ Time Frame: 0, 1, 2.5, 5, 24, 25, 26.5, 29, 48, 49 and 72 hours ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  1. Signed informed consent obtained prior to initiation of any study-specific procedures and study treatment
  2. Documented diagnosis of SARS-CoV-2 infection, determined by either qualitative polymerase chain reaction (PCR) or antigen test by local laboratory, from oro nasopharyngeal exudate collected no more than 72 hours prior to study treatment on Day 1
  3. Patient meets category 5 on the 11-point WHO Clinical Progression Scale: requires hospitalization and oxygen by mask or nasal prongs/cannula
  4. A maximum of 10 days from onset of COVID-19 symptoms to initiation of study treatment on Day 1
  5. Male or female aged ≥18 years
  6. Adequate bone marrow, liver, kidney, and metabolic function, defined by the following tests performed at local laboratory:
    • Absolute neutrophil count ≥1000/mm^3 (1.0 x 10^9/L)
    • Lymphocyte count ≥500/mm^3 (0.5 x 10^9/L)
    • Platelet count ≥100 000/mm^3 (100 x 10^9/L)
    • Haemoglobin >9.0 g/dL
    • Alanine transaminase (ALT), aspartate transaminase (AST) ≤3 x upper limit of normal (ULN)
    • Serum bilirubin ≤1 x ULN
    • Calculated creatinine clearance ≥30 mL/min (Cockcroft and Gault formula)
    • Creatine phosphokinase ≤2.5 x ULN except if the patient has had recent (ie, in the last week) shivering episodes or trauma. In that case, the level of creatine phosphokinase (CPK) should be ≤5 x ULN).
  7. Agree not to participate in another interventional clinical trial through Day 31
  8. Females of reproductive capacity must have a negative serum or urine pregnancy test by local laboratory at study enrolment and must be non-lactating
  9. Females and males with partners of child-bearing potential must use effective contraception while on study treatment and for 6 months after last dose of plitidepsin. Patients in the control arm must use effective contraception at the time indicated in the approved product information (summary of product characteristics [SmPC] or leaflet). If no information is available in the approved product information, patients in the control arm must use effective contraception for at least one week after the study completion or the time indicated based on the investigator's discretion.

Exclusion Criteria:

  1. Subjects with a pre-baseline (ie, in the prior month) impairment in general health condition for whatever reason except COVID 19, requiring either assistance for daily living activities (Barthel index <90/100) or chronic oxygen therapy
  2. Having received treatment for COVID 19 in another clinical trial in the prior 4 weeks, except documented allocation in a placebo arm.
  3. Evidence of respiratory failure at the time of randomisation, based on resource utilisation requiring at least one of the following: endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula, noninvasive positive pressure ventilation, ECMO, or clinical diagnosis of respiratory failure (ie, clinical need for one of the preceding therapies, but preceding therapies not able to be administered in setting of resource limitation)
  4. Patients with severe COVID 19, meeting score >5 on the 11 point WHO Clinical Progression Scale or presenting during the screening any of clinical signs indicative of severe systemic illness, such as respiratory rate ≥30 per minute, heart rate ≥125 per minute, or PaO2/FiO2 <300
  5. Patients receiving treatment with antiviral therapy against SARS-CoV-2 (either small molecules or antibodies, convalescent plasma, monoclonal antibodies, IL 6 receptor inhibitor, or immunomodulatory drugs) within 2 weeks before enrolment. Prior administration of dexamethasone or equivalent glucocorticoid might be acceptable if:
    1. The total daily dose is not higher than 6 mg of dexamethasone base (equivalent to dexamethasone phosphate 7.2 mg/day) or equivalent glucocorticoid
    2. The duration of the treatment does not exceed 72 hours prior to study treatment Day 1
  6. History of live vaccination within the last 4 weeks prior to study enrolment. Regulatory approved, nonreplicative viral vector based vaccines are allowed if given not earlier than 1 week previous to Day 1.
  7. Patients receiving treatment with chloroquine or derivatives within 8 weeks before enrolment or during the study
  8. Patients receiving treatment with strong cytochrome P450 3A4 ( CYP3A4) inhibitors or inducers
  9. Viral illness (other than COVID 19) requiring therapy, except for patients with treated and adequately controlled (undetectable) human immunodeficiency virus infection
  10. Patients with uncontrolled known primary or secondary immunodeficiency, including chronic treatment with glucocorticoids (ie, prednisone at a daily dose of >10 mg for >1 month, or other glucocorticoid at equipotent dose)
  11. Any of the following cardiac conditions or risk factors:
    • Sinus bradycardia (<50 beats/min), sinus nodal dysfunction (sick sinus disease), atrioventricular block of any degree (PR >200 msec), or any other bradyarrhythmia (<50 beats/min), except for patients with permanent pacemakers;
    • Cardiac infarction, cardiac surgery or cardiac insufficiency episode within the last 6 months;
    • Known abnormal value of left ventricular ejection fraction (LVEF < LLN), unless documented confirmation of recovery (LVEF > LLN) in the previous month;
    • QT interval corrected using Fridericia's formula (QTcF) >450 msec for males or >470 msec for females, based on triplicate 12-lead ECG at screening
    • History of known congenital or acquired QT prolongation
    • Uncorrected hypokalaemia, hypocalcaemia (adjusted), and/or hypomagnesemia at screening
    • Concomitant treatments with drugs known to be associated with a risk of QT prolongation or cardiac arrhythmia
    • Troponin test performed at local laboratory > 1.5 x ULN
  12. Pre-existing neuropathies of any type Grade ≥2 according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
  13. Hypersensitivity to the active ingredient or any of the excipients (mannitol, macrogolglycerol hydroxystearate, and ethanol)
  14. Females who are pregnant (negative serum or urine pregnancy test required for all females of child-bearing potential at screening) or breast feeding
  15. Females and males with partners of child-bearing potential (females who are not surgically sterile or postmenopausal defined as amenorrhoea for >12 months) who are not using at least 1 protocol-specified method of contraception
  16. Any other clinically significant medical condition or laboratory abnormality that, in the opinion of the investigator, would jeopardise the safety of the patient or potentially impact patient compliance or the safety/efficacy observations in the study.
Open or close this module Contacts/Locations
Central Contact Person: José Jimeno Doñaque, MD, PhD
Telephone: +34918466000
Email: clinicaltrials@pharmamar.com
Study Officials: José Jimeno Doñaque, MD, PhD
Principal Investigator
PharmaMar
Locations: Argentina
Hospital General Agudos Ignacio
[Not yet recruiting]
Buenos Aires, Argentina, 1428 CABA
Contact:Contact: Ricardo Teijerio
Hospital Francisco Muñiz
[Not yet recruiting]
Ciudad autónoma de Buenos Aires, Argentina, C1282AEN CABA
Contact:Contact: Rubén Solari
Hospital Rawson
[Recruiting]
Cordoba, Argentina, 5000
Contact:Contact: Lorena Ravera
Argentina, Buenos Aires
Instituto Medico Platense S.A.
[Not yet recruiting]
La Plata, Buenos Aires, Argentina, 1900
Contact:Contact: Analia Mykietiuk
Clinica Privada Monte Grande S.A
[Not yet recruiting]
Monte Grande, Buenos Aires, Argentina, 1842
Contact:Contact: Xavier Bocca Ruiz
Argentina, Rio Negro
Clinica Central S.A.
[Not yet recruiting]
Villa Regina, Rio Negro, Argentina, 8336
Contact:Contact: Horacio Ariza
Argentina, Santa Fe
Sanatorio Parque - Rosario
[Not yet recruiting]
Rosario, Santa Fe, Argentina, 2000
Contact:Contact: Luciano Lovesio
Brazil
CEMEC - Centro Multidisciplinar de Estudos Clínicos
[Recruiting]
São Bernardo Do Campo, Brazil, 09715-090
Contact:Contact: Adilson Calvacante
Brazil, BA
Hospital São Rafael
[Recruiting]
Salvador, BA, Brazil, 41253-190
Contact:Contact: Rogerio Passos
Brazil, DF
Chronos Pesquisa Clínica
[Not yet recruiting]
Brasília, DF, Brazil, 72145-450
Contact:Contact: Suzara Lopes
Brazil, MG
Hospital Felicio Rocho
[Recruiting]
Belo Horizonte, MG, Brazil, 30110-934
Contact:Contact: Mozar de Castro Neto
Santa Casa de Misericordia de Passos
[ Not yet recruiting Recruiting]
Passos, MG, Brazil, 37902-413
Contact:Contact: Priscila Freitas das Neves(Goncalves)
Brazil, RN
CePCLIN - Centro de Estudos e Pesquisas em Moléstias Infecciosas Ltda
[Recruiting]
Natal, RN, Brazil, 59025-050
Contact:Contact: Kleber Giovanni Luz
Brazil, RS
Hospital Moinhos de Vento (HMV)
[Not yet recruiting]
Porto Alegre, RS, Brazil, 90035-001
Contact:Contact: Regis Rosa
Brazil, SC
Hospital São José
[Recruiting]
Criciúma, SC, Brazil, 88801-250
Contact:Contact: Felipe Dal Pizzol (NCI)
Bulgaria
University Multiprofile Hospital for Active Treatment Sveta Ekaterina EAD
[Not yet recruiting]
Dimitrovgrad, Bulgaria, 6400
Contact:Contact: Todor Atanasov
Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases - Haskovo
[Not yet recruiting]
Haskovo, Bulgaria, 6300
Contact:Contact: Veselin Kalfov
MHAT "Dr. Nikola Vasiliev" AD
[Not yet recruiting]
Kyustendil, Bulgaria, 2500
Contact:Contact: Sashka Pavlova
Military Medical Academy - MBAL Pleven
[Not yet recruiting]
Pleven, Bulgaria, 5800
Contact:Contact: Aneliya Bogdanova
"Specialised Hospital for Active Treatment for Pneumophthisiatric Diseases Dr. Dimitar Gramatikov - Ruse" Ltd Department of Pneumology and Phthisiatry
[Not yet recruiting]
Ruse, Bulgaria, 7000
Contact:Contact: Elena Docheva
SHATPPD Dr. Dimitar Gramatikov, Ruse Ltd.
[Not yet recruiting]
Ruse, Bulgaria, 7002
Contact:Contact: Hristo Metev
University First MHAT "St.Yoan Krastitel"-Sofia EAD
[Not yet recruiting]
Sofia, Bulgaria, 1142
Contact:Contact: Dinko Valev
University Multiprofile Hospital for Active Treatment ACIBADEM CITY CLINIC TOKUDA HOSPIAL
[Not yet recruiting]
Sofia, Bulgaria, 1407
Contact:Contact: Diana Nikova
"MHAT "Sveta Anna"" - Sofia AD
[Not yet recruiting]
Sofia, Bulgaria, 1570
Contact:Contact: Dimitar Raev
Colombia, Antioquia
CliniSalud del Sur S.A.S - Centro de Investigación
[Recruiting]
Envigado, Antioquia, Colombia, 55422
Contact:Contact: Rafael Garces
Colombia, Atlantico
Organización Clinica Bonnadona Prevenir S.A.S
[Not yet recruiting]
Barranquilla, Atlantico, Colombia, 080020
Contact:Contact: Jose Navarro
Colombia, Atlántico
Clínica de la Costa Ltda.
[Recruiting]
Barranquilla, Atlántico, Colombia, 80020
Contact:Contact: Shirley Patricia Iglesias Pertuz
Colombia, Bogotá D.C.
Sociedad de Cirugía de Bogotá; Hospital de San José
[Not yet recruiting]
Bogotá, Bogotá D.C., Colombia, 111411
Contact:Contact: Rodolfo Eduardo Torres Serrano
Hospital Universitario MEDERI
[Terminated]
Bogotá, Bogotá D.C., Colombia, 111911
Colombia, Caldas
Caja de Compensacion Familiar de Caldas
[Recruiting]
Manizales, Caldas, Colombia, 170003
Contact:Contact: Jorge Ivan Marin
France
Centre Hospitalier Universitaire (CHU) Dijon Bourgogne - Hopital Francois Mitterand
[Recruiting]
Dijon, France, 21079
Contact:Contact: Lionel Piroth
Nouvel Hôpital Civil Service des maladies infectieuses
[Recruiting]
Strasbourg, France, 67091
Contact:Contact: Loic Kassagne
Centre Hospitalier Regional et Universitaire de Tours (CHRU Tours) - Hopital Bretonneau
[Recruiting]
Tours, France, 37044
Contact:Contact: M.Adrien Lemaignen
France, Drome
CH Valence
[ Not yet recruiting Recruiting]
Valence, Drome, France, 26953
Contact:Contact: Julie Saison
Greece
Democritus University Hospital University General Hospital of Alexandroupolis
[Not yet recruiting]
Alexandroupoli, Greece, 68100
Contact:Contact: Periklis Panagopoulos
Evangelismos Hospital General Hospital of Athens Evangelismos, Intensive Care Unit
[Recruiting]
Athens, Greece, 106 76
Contact:Contact: Anastasia Kotanidou
Sotiria Hospital General Hospital of Chest Diseases of Athens "Sotiria" 3rd Department of Internal Medicine of University of Athens
[Recruiting]
Athens, Greece, 115 27
Contact:Contact: Garyfallia Poulakou
General Hospital of Athens Alexandra
[Recruiting]
Athens, Greece, 115 28
Contact:Contact: Meletios Dimopoulos
General Hospital of Athens "Laiko", University of Athens Agiou
[Not yet recruiting]
Athens, Greece, 11527
Contact:Contact: Nikolaos Sypsas
Attikon Hospital
[Recruiting]
Chaïdári, Greece, 12462
Contact:Contact: Dimitrios Boumpas
Tzaneio Hospital General Hospital of Piraeus Tzaneio
[Recruiting]
Piraeus, Greece, 185 36
Contact:Contact: Styliani Gerakari
Mexico, Ags
Hospital Cardiologica Aguascalientes
[Recruiting]
Aguascalientes, Ags, Mexico, 20230
Contact:Contact: Francisco Marquez Diaz
Mexico, CHH
Sanatorio Palmore, A.C.
[Recruiting]
Chihuahua, CHH, Mexico, 31020
Contact:Contact: Hugo Sánchez
Mexico, Cdmx
Centro Médico ABC
[Not yet recruiting]
Mexico City, Cdmx, Mexico, 05330
Contact:Contact: Brenda Gomez
Hospital Médica Sur
[Terminated]
Mexico City, Cdmx, Mexico, 14050
INER
[Not yet recruiting]
Mexico City, Cdmx, Mexico, 14080
Contact:Contact: Victor Hugo Ahumada
Mexico, DIF
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
[Not yet recruiting]
Mexico City, DIF, Mexico, 14000
Contact:Contact: Sergio Ivan Valdes Ferrer
Mexico, Michoacan
Centro de Investigación Clínica Chapultepec
[Recruiting]
Morelia, Michoacan, Mexico, 58260
Contact:Contact: Guillermo Priciliano Montes Garcia
Mexico, Méx
Hospital Español
[Not yet recruiting]
Ciudad de México, Méx, Mexico, 52763
Contact:Contact: José Juan Donis Hernández
Hospital Angeles (Lomas)
[Not yet recruiting]
Mexico City, Méx, Mexico, 52763
Contact:Contact: Raymundo Rodriguez Sandoval
Mexico, NL
Universidad Autonoma de Nuevo Leon - Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
[Recruiting]
Monterrey, NL, Mexico, 64460
Contact:Contact: Eduardo Pérez Alba
Peru, Lima
Hospital Alberto Sabogal Sologuren
[Not yet recruiting]
Bellavista, Lima, Peru, Callao 2
Contact:Contact: Luis Enrique Hercilla Vasquez
Hospital de Chancay
[Not yet recruiting]
Chancay, Lima, Peru, 15131
Contact:Contact: Jose Zambrano
Contact:Contact: Lisbeth Cahuas Villanueva
Hospital Nacional Hipolito Unanue (HNHU)
[Not yet recruiting]
El Agustino, Lima, Peru, 15007
Contact:Contact: Ricardo Sanchez
Universidad Peruana Cayetano Heredia (UPCH) - Hospital Cayetano Heredia (HCH)
[Not yet recruiting]
Lima Cercado, Lima, Peru, 10680
Contact:Contact: Carlos Rafael Seas Ramos
Portugal
HULC - Hospital de Curry Cabral
[Not yet recruiting]
Lisboa, Portugal, 1069-166
Contact:Contact: Fernando Maltez
Romania
Institutul National De Boli Infectioase "Prof. Dr. Matei Bals"
[Recruiting]
Bucharest, Romania, 021105
Contact:Contact: Liliana Lucia Preotescu
Spitalul Clinic de Boli Infectioase si Tropicale Dr. Victor Babes - Bucharest
[Recruiting]
Bucharest, Romania, 030303
Contact:Contact: Simin Aysel Florescu
Institutul National De Boli Infectioase "Prof. Dr. Matei Bals"
[Recruiting]
Bucharest, Romania, 21105
Contact:Contact: Anca Streinu-Cercel
Spitalul Clinic Universitar de Urgenta Bucuresti
[Not yet recruiting]
Bucharest, Romania, 50098
Contact:Contact: Laura Sorina Diaconu
Spitalul Clinic De Boli Infectioase "Sfanta Parascheva" IASI, Sectia Boli Infectioase III
[Recruiting]
Iaşi, Romania, 700116
Contact:Contact: Mihaela Catalina Luca
Spitalul Judetean de Urgenta 'Sf. Ioan cel Nou' Suceava, Sectia de Boli Infectioase
[Recruiting]
Suceava, Romania, 720237
Contact:Contact: Olga Caliman-Sturdza
Romania, Cluj
Spitalul Clinic De Boli Infectioase Cluj-Napoca, Sectia HIV/SIDA
[Recruiting]
Cluj-Napoca, Cluj, Romania, 400000
Contact:Contact: Cristian Jianu
Romania, Tomis
Spitalul Clinic de Boli Infectioase Constanta
[Not yet recruiting]
Constanţa, Tomis, Romania, 900709
Contact:Contact: Simona Cambrea
South Africa, Gauteng
Netcare Lakeview Hospital
[Recruiting]
Benoni, Gauteng, South Africa, 1500
Contact:Contact: Nazreen Jeewa Hussen
South Africa, Western Cape
Tiervlei Trial Centre
[Recruiting]
Cape Town, Western Cape, South Africa, 7530
Contact:Contact: Matthys Basson
TASK eden
[Recruiting]
George, Western Cape, South Africa, 6530
Contact:Contact: Kirsten McHarry
Spain
Hospital General Universitario de Alicante
[Recruiting]
Alicante, Spain, 3010
Contact:Contact: Esperanza Merino
Complejo Asistencial Universitario de Burgos - Hospital Universitario de Burgos
[Not yet recruiting]
Burgos, Spain, 9006
Contact:Contact: Luis Buzon Martin
Universidad de Cadiz (UCA) - Hospital Universitario Puerta del Mar (HUPM)
[Recruiting]
Cadiz, Spain, 11009
Contact:Contact: Jose Giron-Gonzalez
Hospital Universitario Virgen de las Nieves (HUVN)
[ Not yet recruiting Recruiting]
Granada, Spain, 18014
Contact:Contact: Carmen Hidalgo-Tenorio
Hospital Clinico San Cecilio
[Recruiting]
Granada, Spain, 18016
Contact:Contact: Jose Hernandez Quero
Hospital Universitario de Guadalajara
[Recruiting]
Guadalajara, Spain, 19002
Contact:Contact: Miguel Torralba
Hospital Universitari Arnau de Vilanova de Lleida
[Recruiting]
Lleida, Spain, 25198
Contact:Contact: Alfredo Jover
H.U. La Princesa
[Recruiting]
Madrid, Spain, 28006
Contact:Contact: Julio Ancochea
Hospital Gregorio Marañón
[Recruiting]
Madrid, Spain, 28007
Contact:Contact: Patricia Muñoz
Hospital Universitario Moncloa
[Recruiting]
Madrid, Spain, 28008
Contact:Contact: Carlos Zarco Alonso
Hospital Infanta Leonor
[Recruiting]
Madrid, Spain, 28032
Contact:Contact: Pablo Ryan
Hospital Universitario Ramón y Cajal
[Recruiting]
Madrid, Spain, 28034
Contact:Contact: Jesús Fortun-Abete
Fundacion Jimenez Diaz
[Recruiting]
Madrid, Spain, 28040
Contact:Contact: Miguel Gorgolas
Hospital Clínico San Carlos
[Recruiting]
Madrid, Spain, 28040
Contact:Contact: Vicente Estrada
Hospital 12 Octubre
[Recruiting]
Madrid, Spain, 28041
Contact:Contact: Cristina De La Calle
H. HM Sanchinarro
[Recruiting]
Madrid, Spain, 28050
Contact:Contact: Paula Villares
Hospital de Emergencias Enfermera Isabel Zendal
[Recruiting]
Madrid, Spain, 28055
Contact:Contact: Pedro Landete
Complexo Hospitalario de Pontevedra
[Recruiting]
Pontevedra, Spain, 36071
Contact:Contact: Adolfo Baloiro Villar
Hospital Universitario de Salamanca
[Recruiting]
Salamanca, Spain, 37007
Contact:Contact: Miguel Marcos Martin
Instituto de Investigación Sanitaria Valdecilla (IDIVAL)
[Recruiting]
Santander, Spain, 39008
Contact:Contact: Maria Del Carmen Farina Alvarez
Hospital Universitario Virgen del Rocío
[Recruiting]
Sevilla, Spain, 41013
Contact:Contact: Jose Miguel Cisneros
Contact:Contact: Inmaculada Rivas Jeremías
Spain, Barcelona
Hospital Universitari Germans Trias i Pujol
[Recruiting]
Badalona, Barcelona, Spain, 08916
Contact:Contact: Roger Paredes
Hospital Universitari de Bellvitge
[Recruiting]
Hospitalet de Llobregat, Barcelona, Spain, 08907
Contact:Contact: Maria Molina
Spain, Cádiz
Hospital Universitario de Jerez de la Frontera
[ Not yet recruiting Recruiting]
Jerez De La Frontera, Cádiz, Spain, 11407
Contact:Contact: Paula García Ocaña
Spain, Cádiz.Spain
Hospital Universitario Puerto Real
[Recruiting]
Puerto Real, Cádiz.Spain, Spain, 11510
Contact:Contact: Alberto Romero-Palacios
Spain, Madrid
Hospital Universitario HM Montepríncipe
[Recruiting]
Boadilla Del Monte, Madrid, Spain, 28668
Contact:Contact: Jose Barberan Lopez
Hospital Universitario de Fuenlabrada
[Not yet recruiting]
Fuenlabrada, Madrid, Spain, 28942
Contact:Contact: Jorge Marrero Frances
Hospital Universitario de Getafe
[Recruiting]
Getafe, Madrid, Spain, 28905
Contact:Contact: Roberto Vates Gómez
HM Puerta del Sur
[Recruiting]
Móstoles, Madrid, Spain, 28038
Contact:Contact: Natalia Castro Iglesias
Hospital Universitario de Móstoles
[Recruiting]
Móstoles, Madrid, Spain, 28935
Contact:Contact: Victor Monero Cuerda
Hospital Quirónsalud Madrid
[Recruiting]
Pozuelo De Alarcón, Madrid, Spain, 28223
Contact:Contact: Pablo Guisado Vasco
Contact:Contact: Ana Roda
HM Torrelodones
[Recruiting]
Torrelodones, Madrid, Spain, 28250
Contact:Contact: Mercedes Villarreal
Spain, Málaga
Hospital Costa Del Sol
[Recruiting]
Marbella, Málaga, Spain, 29603
Contact:Contact: Julian Olalla
Hospital Quirón Marbella
[Recruiting]
Marbella, Málaga, Spain, 29603
Contact:Contact: José María Ignacio García
Spain, Pontevedra
Hospital Álvaro Cunqueiro
[Recruiting]
Vigo, Pontevedra, Spain, 36213
Contact:Contact: Maria-Teresa Perez-Rodriguez
Spain, Vizcaya
Hospital Universitario de Cruces
[Recruiting]
Barakaldo, Vizcaya, Spain, 48903
Contact:Contact: Ane Josune Goikoetxea Agirre
Turkey
Hacettepe University, School of Medicine
[Not yet recruiting]
Ankara, Turkey, 06100
Contact:Contact: Serhat Unal
Ankara City Hospital
[Not yet recruiting]
Ankara, Turkey, 06200
Contact:Contact: Guner Hatice Rahmet
Turkey, Izmir
T.C. Saglik Bakanligi Tepecik Egitim ve Arastirma Hastanesi - Enfeksiyon Hastaliklari ve Klinik Mikrobiyoloji Klinigi
[Not yet recruiting]
Konak, Izmir, Turkey, 35040
Contact:Contact: Sukran Kose
Turkey, Kocaeli
Kocaeli Universitesi - Kocaeli Universitesi Tip Fakultesi - Kocaeli Universitesi Arastirma ve Uygulama Hastanesi
[Not yet recruiting]
İzmit, Kocaeli, Turkey, 41380
Contact:Contact: Sila Akhan
Turkey, İzmir
Ege University Medical School, Department of Infectious Diseases and Clinical Microbiology
[Not yet recruiting]
Bornova, İzmir, Turkey, 35040
Contact:Contact: Husnu Pullukcu
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