NCT04419610

Brief Summary

To determine whether the coagulopathy associated with COVID-19 infection is driven by overactivation of the renin angiotensin system (RAS)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Oct 2020

Shorter than P25 for early_phase_1

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

April 16, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 5, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

October 9, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 12, 2021

Completed
3 years until next milestone

Results Posted

Study results publicly available

May 1, 2024

Completed
Last Updated

May 3, 2024

Status Verified

May 1, 2024

Enrollment Period

7 months

First QC Date

April 16, 2020

Results QC Date

September 27, 2022

Last Update Submit

May 1, 2024

Conditions

COVID

Outcome Measures

Primary Outcomes (1)

  • Coagulopathy Associated With COVID-19

    Change from Day 1 (Baseline) in D-dimer Levels at Day 3

    Day 1 (baseline) and Day 3).

Secondary Outcomes (14)

  • Markers of Dysregulation of Coagulation System

    Day 1 (baseline) and Day 3

  • Markers of Dysregulation of Coagulation System Change From Baseline

    Baseline (Day 1) to Day 3

  • Markers of Dysregulation of Coagulation System

    Baseline (day 1) to Day 3

  • Markers of Dysregulation of Coagulation System

    Baseline (day 1) to Day 3

  • Markers of Dysregulation of Coagulation System

    Baseline (day 1) to Day 3

  • +9 more secondary outcomes

Study Arms (2)

Patients with confirmed/suspected C19 given intervention

EXPERIMENTAL

Intravenous infusion of either placebo or TRV027 at 12mg/hr. Treatment will continue until discharge or for 7 days (whichever is sooner).

Biological: TRV027

Patients with confirmed/suspected C19 given no intervention

PLACEBO COMPARATOR

Saline infusion.

Other: sodium chloride 0.9%

Interventions

TRV027BIOLOGICAL

peptide for infusion

Patients with confirmed/suspected C19 given intervention
sodium chloride 0.9%OTHER

placebo comparator for infusion

Patients with confirmed/suspected C19 given no intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hospitalised with confirmed COVID-19 infection.
  • Screened within 96hrs of SARS-COV-2 positive PCR.
  • Age 18 or over
  • Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
  • Systolic blood pressure between 100 and 180

You may not qualify if:

  • Any unrelated clinical condition, which, in the opinion of the investigator, may affect D-dimer during the course of the study, independent of COVID-19 infection, e.g. subsets of cancers and coagulopathies.
  • Concomitant medication which inhibit the action of TRV027 (ARB's).
  • Any clinically significant medical conditions that in the opinion of the investigator would compromise subjects' safety or compliance with study procedures.
  • Any clinical condition which in the opinion of the principal investigator would compromise the scientific integrity of the study
  • Unwillingness or inability to follow the procedures outlined in the protocol.
  • Subject is pregnant or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperial College NHS Trust

London, W12 0HS, United Kingdom

Location

Related Publications (1)

  • Robbins AJ, Che Bakri NA, Toke-Bjolgerud E, Edwards A, Vikraman A, Michalsky C, Fossler M, Lemm NM, Medhipour S, Budd W, Gravani A, Hurley L, Kapil V, Jackson A, Lonsdale D, Latham V, Laffan M, Chapman N, Cooper N, Szydlo R, Boyle J, Pollock KM, Owen D. The effect of TRV027 on coagulation in COVID-19: A pilot randomized, placebo-controlled trial. Br J Clin Pharmacol. 2023 Apr;89(4):1495-1501. doi: 10.1111/bcp.15618. Epub 2022 Dec 14.

    PMID: 36437688RESULT

MeSH Terms

Interventions

Sar-Arg-Val-Tyr-Ile-His-Pro-Ala-OHSodium Chloride

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Results Point of Contact

Title
Dr David Owen
Organization
Imperial College
d.owen@imperial.ac.uk
07575089144

Study Officials

  • DAVID OWEN

    National Health Service, United Kingdom

    PRINCIPAL INVESTIGATOR

  • Katrina Pollock

    National Health Service, United Kingdom

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2020

First Posted

June 5, 2020

Study Start

October 9, 2020

Primary Completion

May 12, 2021

Study Completion

May 12, 2021

Last Updated

May 3, 2024

Results First Posted

May 1, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)