Status and phase
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About
This study is an adaptive, randomized, open-label, controlled clinical trial, in collaboration with countries around the world through the World Health Organization.
Full description
Subjects will be randomized, across one, two, three or up to four separate randomizations, to receive either standard-of-care products or the study medication plus standard of care, while being hospitalized for COVID-19.
Randomization WHO: Imatinib vs Infliximab vs Artesunate vs Standard of care
Randomization Dex: Dexamethasone vs Standard of care
Randomization LSALT: LSALT Peptide vs Standard of care
Hospitalized subjects will require blood sampling for screening and on days 1 and 5.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Each participant must meet all of the following inclusion criteria to participate in this study:
In addition, there will be the below intervention-specific inclusion:
Randomization WHO will have no other specific inclusion criteria.
Randomization LSALT will have no other specific inclusion criteria.
Randomization Dex will have the following specific inclusion criteria
Exclusion criteria
All participants meeting any of the following exclusion criteria at baseline will be excluded from participation in this study:
In addition, there will be the below intervention-specific exclusions:
Randomization WHO:
These will be drug-specific exclusions; patients will still be eligible for randomization in Randomization WHO to the other available study drugs (in randomization WHO or subsequent randomizations).
Artesunate:
Imatinib:
Infliximab:
Randomization LSALT:
Randomization Dex:
Primary purpose
Allocation
Interventional model
Masking
2,900 participants in 6 patient groups
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Central trial contact
Gail Klein; Rob Fowler, MD
Data sourced from clinicaltrials.gov
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