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

Sponsor

Sunnybrook Health Sciences Centre (Other)

Overall Status

Recruiting

CT.gov ID

NCT04330690

Collaborator

AbbVie (Industry), Apotex Inc. (Industry), World Health Organization (Other), University of British Columbia (Other), Arch Biopartners Inc. (Industry)

2,900

Enrollment

Locations

Arms

Anticipated Duration (Months)

50.9

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Drug: Artesunate Drug: Imatinib Drug: Infliximab Drug: Dexamethasone Drug: LSALT Peptide	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

2900 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Masking Description:

Endpoint assessment

Primary Purpose:

Treatment

Official Title:

A Multi-centre, Adaptive, Randomized, Open-label, Controlled Clinical Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Patients (CATCO: Canadian Treatments for COVID-19), in Conjunction With the Public Health Emergency SOLIDARITY Trial (World Health Organization)

Actual Study Start Date :

Mar 18, 2020

Anticipated Primary Completion Date :

Mar 18, 2023

Anticipated Study Completion Date :

May 18, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Artesunate Subjects will be randomized Artesunate vs Imatinib vs Infliximab vs standard of care	Drug: Artesunate 2.4 mg/kg at 0 hours, 12 hours, 24 hours, and then daily for a total of 7 days plus standard of care
Experimental: Imatinib Subjects will be randomized Artesunate vs Imatinib vs Infliximab vs standard of care	Drug: Imatinib 400 mg enterally daily for 14 days plus standard of care
Experimental: Infliximab Subjects will be randomized Artesunate vs Imatinib vs Infliximab vs standard of care	Drug: Infliximab 5 mg/kg IV given one time, over 2 hours plus standard of care
Experimental: Dexamethasone Subjects will be randomized between Dexamethasone vs standard of care.	Drug: Dexamethasone 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
Experimental: LSALT Peptide Subjects will be randomized between LSALT vs standard of care.	Drug: LSALT Peptide 5 mg , 2 hour IV infusion once daily for up to 14 consecutive days
No Intervention: Control (Standard Care) This arm will receive standard supportive care guidelines for COVID-19. It is expected to vary regionally and may change throughout the trial based on new and emerging data on best care guidelines for patients.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Evaluation of the clinical effectiveness of study drugs [24 months]
To be compared to the control arm on duration of hospitalization
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]
Mortality [12 months]
Mortality after Randomization

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Each participant must meet all of the following inclusion criteria to participate in this study:

≥ 18 years of age
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.
Hospitalized at a participating centre
Primary reason for hospitalization or subsequent in-hospital illness is because of acute COVID19 infection
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

On 10 days of steroid course and
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:

Anticipated transfer to another hospital, within 72 hours, which is not a study site
Expected to not survive beyond 24 hours
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:

Known hypersensitivity to artesunate

Imatinib:

Pregnant or breastfeeding;
Known hypersensitivity to imatinib;
Liver transaminases (either ALT or AST) > 5x upper limit of normal

Infliximab:

Known moderate or severe heart failure, per treating clinician, defined as New York Heart Association (NYHA) class III or IV
Known or suspected active tuberculosis
Known hypersensitivity to infliximab

Randomization LSALT:

Known hypersensitivity or prior use of LSALT peptide.
Pregnant or breastfeeding

Randomization Dex:

Receiving glucocorticoids for a specific, non-COVID-19 indication

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peter Lougheed Centre	Calgary	Alberta	Canada	T1Y 6J4
2	Foothills Medical Centre	Calgary	Alberta	Canada	T2N 2T9
3	Rockyview General Hospital	Calgary	Alberta	Canada	T2V 1P9
4	South Health Campus	Calgary	Alberta	Canada	T3M 1M4
5	Royal Alexandra Hospital	Edmonton	Alberta	Canada	T5K0L4
6	Misericordia Community Hospital	Edmonton	Alberta	Canada	T5R 4H5
7	University of Alberta Hopsital	Edmonton	Alberta	Canada	T6G 2B7
8	Grey Nuns Community Hospital	Edmonton	Alberta	Canada	T6L 5X8
9	Interior Health Royal Inland Hospital	Kamloops	British Columbia	Canada	V2C2T1
10	Lions Gate Hospital	North Vancouver	British Columbia	Canada	V7L 2L7
11	Richmond Hospital	Richmond	British Columbia	Canada	V6X 1A2
12	Vancouver General Hospital, Vancouver Coastal Health, Univeristy of British Columbia	Vancouver	British Columbia	Canada	V5Z1M9
13	St Paul's Hospital	Vancouver	British Columbia	Canada	V6Z 1Y6
14	Island Health - Royal Jubilee Hospital	Victoria	British Columbia	Canada	V8R 1J8
15	Island Health - Victoria General Hospital	Victoria	British Columbia	Canada	V8Z 6R5
16	Island Health - Nanaimo Regional General Hospital	Victoria	British Columbia	Canada	V9S 2B7
17	St. Boniface Hospital	Winnipeg	Manitoba	Canada	R2H 2A6
18	Health Sciences Centre	Winnipeg	Manitoba	Canada	R3A 1R9
19	Grace General Hospital	Winnipeg	Manitoba	Canada	R3J 3M7
20	Eastern Regional Health Authority	Saint John's	Newfoundland and Labrador	Canada	A1B 3V6
21	Nova Scotia Health Authority	Halifax	Nova Scotia	Canada	B3S 0H6
22	Royal Victoria Regional Health Centre	Barrie	Ontario	Canada	L4M 6M2
23	William Osler Health System - Brampton Civic Hospital	Brampton	Ontario	Canada	L6R 3J7
24	William Osler Health System - Etobicoke General Hospital	Etobicoke	Ontario	Canada	M9V 1R8
25	St. Joseph's Healthcare Hamilton	Hamilton	Ontario	Canada	L8N 4A6
26	Grand River Hospital	Kitchener	Ontario	Canada	N2G 1G3
27	St. Mary's General Hospital	Kitchener	Ontario	Canada	N2M 1B2
28	St.Joseph's Health Care	London	Ontario	Canada	N6A 4V2
29	University Hospital	London	Ontario	Canada	N6A 5A5
30	Victoria Hospital	London	Ontario	Canada	N6A 5W9
31	Markham Stouffville Hospital	Markham	Ontario	Canada	L3P 7P3
32	Trillium Health Partners -Mississauga Site	Mississauga	Ontario	Canada	L5B 1B8
33	Trillium Health Partners-Credit Valley Hospital	Mississauga	Ontario	Canada	L5M 2N1
34	The Ottawa Hospital - General Campus	Ottawa	Ontario	Canada	K1H 8L6
35	Hôpital Montfort	Ottawa	Ontario	Canada	K1K 0T2
36	The Ottawa Hospital - Civic Campus	Ottawa	Ontario	Canada	K1Y 4E9
37	Queensway Carleton Hospital	Ottawa	Ontario	Canada	K2H 8P4
38	Niagara Health	Saint Catharines	Ontario	Canada	L2S 0A9
39	Scarborough Health Network - Centenary Hospital	Scarborough	Ontario	Canada	M1E4B9
40	Scarborough Health Network - General Hospital	Scarborough	Ontario	Canada	M1P2V5
41	Scarborough Health Network - Birchmount Hospital	Scarborough	Ontario	Canada	M1W3W3
42	Thunder Bay Regional Health Sciences Centre	Thunder Bay	Ontario	Canada	P7B 6V4
43	North York General Hospital	Toronto	Ontario	Canada	M2K 1E1
44	Humber River Hospital	Toronto	Ontario	Canada	M3M 0B2
45	Michael Garron Hospital	Toronto	Ontario	Canada	M4C 3E7
46	Sunnybrook Health Sciences Centre	Toronto	Ontario	Canada	M4N3M5
47	St. Michael's Hospital	Toronto	Ontario	Canada	M5B 1W8
48	Mount Sinai Hospital	Toronto	Ontario	Canada	M5G 1X5
49	Toronto Western Hospital	Toronto	Ontario	Canada	M5T2S8
50	Unity Health Toronto - St. Joseph's Health Centre	Toronto	Ontario	Canada	M6R1B5
51	CISSS de la Montérégie Centre	Greenfield Park	Quebec	Canada	J4V 2H1
52	Centre Hospitalier de l'Université de Montréal (CHUM)	Montréal	Quebec	Canada	H2X 0A9
53	McGill University Health Centre-Glen Site Royal Victoria Hospital	Montréal	Quebec	Canada	H4A 3J1
54	CHU de Québec - Université Laval	Québec	Quebec	Canada	G1J 1Z4
55	Institut Universitaire de Cardiologie et de Pneumologie de Québec- Université Laval	Québec	Quebec	Canada	G1V 4G5
56	Centre Intégré Universitaire de Santé et de Services Sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke	Sherbrooke	Quebec	Canada	J1H 5N4
57	Royal University Hospital	Saskatoon	Saskatchewan	Canada	S7N 0W8