NCT04748757

Brief Summary

Randomized, double-blind, placebo-controlled trial comparing 2 doses of SY-005 (recombinant human Annexin A5) to placebo in patients with severe coronavirus 2019 disease in a single hospital centre with 2 intensive care units

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 10, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

April 20, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

March 8, 2023

Status Verified

March 1, 2023

Enrollment Period

12 months

First QC Date

February 2, 2021

Last Update Submit

March 7, 2023

Conditions

Coronavirus InfectionSepsis

Outcome Measures

Primary Outcomes (3)

  • Enrollment

    Participants enrolled per site per month with success defined as enrollment \>= 50% of screened eligible patients

    12 months

  • Protocol adherence

    Delivery of investigational product within 1 hour of scheduled dose; success defined as \>= 90%

    7 days

  • Data completeness

    Case Report Forms completed with \<10% missing data after verification and monitoring

    12 months

Secondary Outcomes (17)

  • Organ failure

    30 days

  • Organ function at end of treatment measured with SOFA

    7 days

  • Organ function at end of treatment measured with Multiple Organ Dysfunction Score (MODS)

    7 days

  • Individual organ function scores at EOT measured with SOFA

    30 days

  • Individual organ function scores at 30 days measured with SOFA

    30 days

  • +12 more secondary outcomes

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Normal saline, 50 ml infusion over 30 minutes every 12 hours for 7 days

Drug: Placebo

Low dose

EXPERIMENTAL

50 microg/kg SY-005 in 50 ml saline infused over 30 minutes every 12 hours for 7 days

Drug: recombinant human annexin A5

High dose

EXPERIMENTAL

100 microg/kg SY-005 in 50 ml saline infused over 30 minutes every 12 hours for 7 days

Drug: recombinant human annexin A5

Interventions

recombinant human annexin A5DRUG

recombinant human annexin A5, manufactured as SY-005

Also known as: SY-005
High doseLow dose
PlaceboDRUG

Normal saline 50 ml

Placebo

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 19 years
  • Positive test for SARS-CoV-2 virus (anytime during current illness episode)
  • Admitted to intensive care for organ failure support (at least one of vasopressor, non-invasive or invasive ventilation)

You may not qualify if:

  • Known allergy to any of the ingredients or components of the investigational product
  • Known pregnancy
  • Moribund and not expected to survive beyond 24 hours
  • Acute or chronic renal failure (dialysis dependent)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

Related Publications (1)

  • Tschirhart BJ, Lu X, Mokale Kognou AL, Martin CM, Slessarev M, Fraser DD, Leligdowicz A, Urquhart B, Feng Q. Pharmacokinetics of recombinant human annexin A5 (SY-005) in patients with severe COVID-19. Front Pharmacol. 2024 Jan 10;14:1299613. doi: 10.3389/fphar.2023.1299613. eCollection 2023.

    PMID: 38269269DERIVED

MeSH Terms

Conditions

Coronavirus InfectionsSepsis

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Claudio Martin, MD, MSc

    London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2021

First Posted

February 10, 2021

Study Start

April 20, 2021

Primary Completion

April 3, 2022

Study Completion

December 1, 2022

Last Updated

March 8, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will share

Information and data sharing will be considered on individual basis at conclusion of the study.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
To be evaluated on individual basis

Locations

CA(1)