Back to resultsHeat Shock Protein Inhibitor- MPT0B640 for COVID-19 Infection
Primary Purpose
Covid19
Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
MPT0B640
Sponsored by
About this trial
This is an interventional treatment trial for Covid19
Eligibility Criteria
Inclusion Criteria:
Subjects must meet all inclusion criteria as listed below:
- Age ≥18 years at time of signing Informed Consent Form
- Laboratory (quantitative Polymerase Chain Reaction, qPCR) confirmed infection with 2019-nCoV.
- Lung involvement confirmed with chest imaging
- Hospitalized with a SaO2/SPO2≤94% on room air or PaO2/FiO2 ratio <300mgHg
- ≤7 days since illness onset
- Must agree not to enroll in another study of an investigational agent prior to completion of Day 12 of study.
Exclusion Criteria:
- Physician makes a decision that trial involvement is not in patients' best interest, or any condition that does not allow the protocol to be followed safely.
- Severe liver disease (e.g. Child Pugh score ≥ C, AST>5 times upper limit)
- Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination
- Patients with known severe renal impairment (estimated glomerular filtration rate ≤30 mL/min/1.73 m2) or receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis
- Will be transferred to another hospital which is not the study site within 72 hours.
- Receipt of any experimental treatment for 2019-nCoV (off-label, compassionate use, or trial related) within the 30 days prior to the time of the screening evaluation.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
MPT0B640
Arm Description
There is single Arm in this clinical trials.
Outcomes
Primary Outcome Measures
MTD
MTD is defined as highest dose level in which 6 subjects have been treated with less than 2 instances of DLT. DLT assessed during the study treatment period (28 ± 2 days) refers to a medically significant event which meets one of the criteria using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
Secondary Outcome Measures
Viral load
Viral load change (log10 viral load assessed by reverse transcription-qPCR)
Time to clinical improvement
Assessed TTCI with WHO clinical progression scale by measuring clinical status daily. TTCI is defined as the time (in days) from initiation of study treatment until a decline of one category on WHO clinical progression scale which ranges from 0 (uninfected; no viral RNA detected) to 10 (death)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04526717
Brief Title
Heat Shock Protein Inhibitor- MPT0B640 for COVID-19 Infection
Official Title
Phase 1, Open Label, Single Arm Study to Evaluate the Safety, Tolerability and Efficacy of MPT0B640 in Patients With COVID-19 Infection
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Study was determined not to initiate.
Study Start Date
December 2021 (Anticipated)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
J Ints Bio
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Indication : Treatment of Subject with COVID-19 infection Phase : Phase I Duration of Study : 12 day Sample size : at least 15 subjects Methodology : Classical 3+3 design Investigational Product : MPT0B640, 15, 30, 60, 80 and 100mg, oral suspension Study Objective
Primary Objective To determine the maximum tolerated dose (MTD) or maximum feasible dose (MFD) of MPT0B640
Secondary Objectives To evaluate the safety and tolerability of MPT0B640 during entire study period To assess the efficacy of MPT0B640 To characterize the 48 hours PK of MPT0B640
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Classical 3+3 design to determine MTD.
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MPT0B640
Arm Type
Other
Arm Description
There is single Arm in this clinical trials.
Intervention Type
Drug
Intervention Name(s)
MPT0B640
Intervention Description
Each dose of MPT0B640 will be administrated per Cohort. (15, 30, 60, 80, 100 mg of MPT0B640)
Primary Outcome Measure Information:
Title
MTD
Description
MTD is defined as highest dose level in which 6 subjects have been treated with less than 2 instances of DLT. DLT assessed during the study treatment period (28 ± 2 days) refers to a medically significant event which meets one of the criteria using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
Time Frame
28days(+/-2days)
Secondary Outcome Measure Information:
Title
Viral load
Description
Viral load change (log10 viral load assessed by reverse transcription-qPCR)
Time Frame
Time Frame: Day 1, 3, 5, 7, 9 and 12
Title
Time to clinical improvement
Description
Assessed TTCI with WHO clinical progression scale by measuring clinical status daily. TTCI is defined as the time (in days) from initiation of study treatment until a decline of one category on WHO clinical progression scale which ranges from 0 (uninfected; no viral RNA detected) to 10 (death)
Time Frame
Time Frame: dialy up to Day 10
Other Pre-specified Outcome Measures:
Title
Pharmacokinetic (PK)
Description
Cmax
Time Frame
Day 1,3 and 5.
Title
Pharmacokinetic (PK)
Description
Ctrough
Time Frame
Day 1,3 and 5.
Title
Pharmacokinetic (PK)
Description
AUCτ
Time Frame
Day 1,3 and 5.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects must meet all inclusion criteria as listed below:
Age ≥18 years at time of signing Informed Consent Form
Laboratory (quantitative Polymerase Chain Reaction, qPCR) confirmed infection with 2019-nCoV.
Lung involvement confirmed with chest imaging
Hospitalized with a SaO2/SPO2≤94% on room air or PaO2/FiO2 ratio <300mgHg
≤7 days since illness onset
Must agree not to enroll in another study of an investigational agent prior to completion of Day 12 of study.
Exclusion Criteria:
Physician makes a decision that trial involvement is not in patients' best interest, or any condition that does not allow the protocol to be followed safely.
Severe liver disease (e.g. Child Pugh score ≥ C, AST>5 times upper limit)
Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination
Patients with known severe renal impairment (estimated glomerular filtration rate ≤30 mL/min/1.73 m2) or receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis
Will be transferred to another hospital which is not the study site within 72 hours.
Receipt of any experimental treatment for 2019-nCoV (off-label, compassionate use, or trial related) within the 30 days prior to the time of the screening evaluation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ethan Seah
Organizational Affiliation
J Ints Bio
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Heat Shock Protein Inhibitor- MPT0B640 for COVID-19 Infection
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