COVID-19
Conditions
Keywords
Artesunate, Infliximab, Imatinib, Dexamethasone, SARS-CoV-2, LSALT Peptide
Brief summary
This study is an adaptive, randomized, open-label, controlled clinical trial, in collaboration with countries around the world through the World Health Organization.
Detailed 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.
Interventions
DRUGArtesunate
2.4 mg/kg at 0 hours, 12 hours, 24 hours, and then daily for a total of 7 days plus standard of care
DRUGImatinib
400 mg enterally daily for 14 days plus standard of care
DRUGInfliximab
5 mg/kg IV given one time, over 2 hours plus standard of care
DRUGDexamethasone
6 mg IV/oral for a further five days, followed by a five day taper of 4 mg x 2 days and 2 mg x 3 days, for a total 20 day steroid course. If randomized to standard of care, discontinue the corticosteroid on day 10
DRUGLSALT Peptide
5 mg , 2 hour IV infusion once daily for up to 14 consecutive days
Sponsors
AbbVie
Apotex Inc.
World Health Organization
University of British Columbia
Arch Biopartners Inc.
Sunnybrook Health Sciences Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Endpoint assessment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Each participant must meet all of the following inclusion criteria to participate in this study: 1. ≥ 18 years of age 2. Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen, within 14 days prior to randomization. 3. Hospitalized at a participating centre 4. Primary reason for hospitalization or subsequent in-hospital illness is because of acute COVID19 infection 5. First admission for acute COVID19 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 1. On 10 days of steroid course and 2. Receiving any supplemental oxygen for 10 days
Exclusion criteria
All participants meeting any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Randomization WHO- Mortality | 28 days | All-cause mortality, assessed at hospital discharge. |
| Randomization Dex- Clinical Status | 28 days | Position on the WHO Ordinal scale at 28 days post-randomization. Ordinal Scale Table: 0 Uninfected; 1-3 Ambulatory; 4-5 Hospitalized/ Mild disease; 6-9 Hospitalized/ Severe Disease; 10 Death |
| Randomization LSALT- Respiratory support | 28 days | Number of days respiratory support free days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the clinical effectiveness of study drugs | 24 months | To be compared to the control arm on duration of hospitalization |
| Mortality | 12 months | Mortality after Randomization |
| Need for invasive mechanical ventilation | 24 months | — |
| CU admission, hospital and ICU length of stay, days alive and free of vasopressors, ventilation, and renal replacement therapy (RRT | 24 months | — |
Countries
Canada
Outcome results
None listed