Anticoagulation in Patients Suffering From COVID-19 Disease The ANTI-CO Trial

NCT04445935 | Unknown Phase 4 DMC

• 1 other identifier: MRC-05-082
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with COVID-19 associated ARDS and mechanical ventilation have a high mortality. Part of the disease is an activation of the coagulation system which seems to contribute to clotformation in the pulmonary bloodstream. Recently we implemented an algorithm applying higher doses of heparins (LMWH). However, this approach could not inhibit clotformation enough. Bivalirudin could prevent clotformation better and support dissolving existing clots. Therefore, we want to compare 50 patients with the standard treatment with 50 patients under bivalirudin treatment which we normally apply in patients with a HIT-syndrome. Our primary outcome measure is oxygenation reflected as P/F ratio.

Conditions

Anticoagulation in COVID-19 ARDS

Keywords

COVID-19; ARDS; Anticoagulation

Outcome Measures

Primary Outcomes (1)

• P/F ratio

  the P/F ratio is a surrogate parameter for oxygenation in ARDS.

  three days of intervention

Secondary Outcomes (1)

• Kidney function

  three days of intervention

Study Arms (2)

Standard treatment

ACTIVE COMPARATOR

In this arm the patients will be treated according to our standard anticoagulation protocol. The patients will not be treated with Bivalirudin (the investigational drug).

Drug: Standard treatment

Bivalirudin arm

EXPERIMENTAL

The patients will be anticoagulated according to the institutional HIT-protocol which uses Bivalirudin as anticoagulant.

Drug: Bivalirudin Injection

Interventions

Bivalirudin Injection DRUG

The patients will receive iv Bivalirudin according to the institutional HIT protocol.

Also known as: anticoagulation

Bivalirudin arm

Standard treatment DRUG

This group will receive standard anticoagulation with LMWH/UFH

Standard treatment

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patient (≥ 18 years of age)
• Positive COVID-test
• Under mechanical ventilation
• D-Dimers\>1.2 mg/L

You may not qualify if:

• Pregnancy
• Allergy to the drug (bivalirudin)
• Inherited coagulation abnormalities
• No informed consent

Sponsors & Collaborators

• Hamad Medical Corporation: lead

Study Sites (1)

Hamad Medical Corporation

Doha, Qatar

RECRUITING

Related Publications (2)

• Flumignan RL, Civile VT, Tinoco JDS, Pascoal PI, Areias LL, Matar CF, Tendal B, Trevisani VF, Atallah AN, Nakano LC. Anticoagulants for people hospitalised with COVID-19. Cochrane Database Syst Rev. 2022 Mar 4;3(3):CD013739. doi: 10.1002/14651858.CD013739.pub2.

  PMID: 35244208 DERIVED

• Kharma N, Roehrig S, Shible AA, Elshafei MS, Osman D, Elsaid IM, Mustafa SF, Aldabi A, Smain OAM, Lance MD. Anticoagulation in critically ill patients on mechanical ventilation suffering from COVID-19 disease, The ANTI-CO trial: A structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Sep 7;21(1):769. doi: 10.1186/s13063-020-04689-1.

  PMID: 32895056 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

bivalirudin

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Marcus Lance, MD, PhD

  HMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcus Lance, MD, PhD

CONTACT

00974; mlance@hamad.qa

Stefan Roehrig, MD, MBA

CONTACT

00974; srohrig@hamad.qa

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study will be blinded to the above mentioned group. The PI is not involved in active treatment. Patients are sedated and ventilated when treatment starts and finally the outcome assessors will not be knowing the patients treatment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr. Marcus Lance

Model Details: This is a randomized controlled trial.

Study Record Dates

• First Submitted: June 23, 2020
• First Posted: June 24, 2020
• Study Start: June 28, 2020
• Primary Completion: September 28, 2020
• Study Completion: March 28, 2021
• Last Updated: June 24, 2020

Record last verified: 2020-06

Locations

QA (1)