Status:
WITHDRAWN
Heat Shock Protein Inhibitor- MPT0B640 for COVID-19 Infection
Lead Sponsor:
J Ints Bio
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 : MPT...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04526717
Start Date
December 1 2021
End Date
December 1 2022
Last Update
June 11 2021
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