Treatments for COVID-19: Canadian Arm of the SOLIDARITY Trial

Sunnybrook Health Sciences Centre2,900 enrolled

Overview

This study is an adaptive, randomized, open-label, controlled clinical trial, in collaboration with countries around the world through the World Health Organization.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

2,900

Conditions

COVID-19

Interventions

ArtesunateDRUG

2.4 mg/kg at 0 hours, 12 hours, 24 hours, and then daily for a total of 7 days plus standard of care

ImatinibDRUG

400 mg enterally daily for 14 days plus standard of care

InfliximabDRUG

5 mg/kg IV given one time, over 2 hours plus standard of care

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 exclusion criteria at baseline will be excluded from participation in this study: 1. Anticipated transfer to another hospital, within 72 hours, which is not a study site 2. Expected to not survive beyond 24 hours 3. Receiving one of the study drugs at time of enrolment 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: 1\. Known hypersensitivity to artesunate Imatinib: 1. Pregnant or breastfeeding; 2. Known hypersensitivity to imatinib; 3. Liver transaminases (either ALT or AST) \> 5x upper limit of normal Infliximab: 1. Known moderate or severe heart failure, per treating clinician, defined as New York Heart Association (NYHA) class III or IV 2. Known or suspected active tuberculosis 3. Known hypersensitivity to infliximab Randomization LSALT: 1. Known hypersensitivity or prior use of LSALT peptide. 2. Pregnant or breastfeeding Randomization Dex: 1\. Receiving glucocorticoids for a specific, non-COVID-19 indication

Locations (53)

Outcomes

Primary Outcomes

Randomization WHO- Mortality

All-cause mortality, assessed at hospital discharge.

Time frame: 28 days

Randomization Dex- Clinical Status

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

Time frame: 28 days

Randomization LSALT- Respiratory support

Number of days respiratory support free days

Time frame: 28 days

Secondary Outcomes

Evaluation of the clinical effectiveness of study drugs

To be compared to the control arm on duration of hospitalization

Time frame: 24 months

Need for invasive mechanical ventilation

Time frame: 24 months

CU admission, hospital and ICU length of stay, days alive and free of vasopressors, ventilation, and renal replacement therapy (RRT

Time frame: 24 months

Mortality

Mortality after Randomization

Time frame: 12 months

Data from ClinicalTrials.gov

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Calgary, Alberta, Canada

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...and 43 more locations