NCT04922814

Brief Summary

Many questions about management of COVID-19 are still not answered. So, we recruit this study aiming to evaluate improvement of oxygenation in COVID-19 patients with severe ARDS, to improve morbidity and mortality of ICU covid patients, to participate in understanding of real hidden pathophysiology of COVID-19.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 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

June 8, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 11, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

December 24, 2025

Status Verified

December 1, 2025

Enrollment Period

7 months

First QC Date

June 8, 2021

Last Update Submit

December 18, 2025

Conditions

COVID-19 Acute Respiratory Distress SyndromeSedation ComplicationICU Acquired Weakness

Outcome Measures

Primary Outcomes (1)

  • PaO2/FiO2

    ratio of arterial oxygen pressure in millilitre mercury to fraction of inspired oxygen at same time within the arterial blood gas

    48 hours

Secondary Outcomes (7)

  • Change in lung mechanics

    48 hours

  • SOFA score

    48 hours

  • Measurement of tissue perfusion

    48 hours

  • Monitoring of Alveolar - Arterial Oxygen difference

    48 hours

  • 28 days survival

    after 28 days

  • +2 more secondary outcomes

Study Arms (2)

Control group(group A)

NO INTERVENTION

Only sedation for mechanically ventilated COVID patients

Muscle relaxant group(group B)

EXPERIMENTAL

They will receive muscle relaxation treatment for at least 48 hours. Cisatracurium will be given. Short term infusions up to 24 hours will be given in a dose rate of 2-3 mic/Kg/min followed by intervallic shots of 2-5 mg.

Drug: muscle relaxation

Interventions

muscle relaxationDRUG

They will receive muscle relaxation treatment for at least 48 hours. Cisatracurium will be given. Short term infusions up to 24 hours will be given in a dose rate of 2-3 mic/Kg/min followed by intervallic shots of 2-5 mg.

Muscle relaxant group(group B)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Severe ARDS: PaO2/FiO2 \<200, resistant hypoxemia and tachypnoea (RR \> 40 breath/minute)
  • Not relieved by high frequency nasal canula or CPAP.
  • Need for invasive mechanical ventilation (uncooperative)

You may not qualify if:

  • Patient relatives' refusal
  • Not mechanically ventilated.
  • Combination of female, corticosteroids administration and vecuronium muscle relaxant.
  • Neuromuscular diseases (especially demyelinating diseases).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university, faculty of medicine, anesthesia and ICU and pain management department

Asyut, Asyut Governorate, 71515, Egypt

Location

Related Publications (4)

  • Mason RJ. Pathogenesis of COVID-19 from a cell biology perspective. Eur Respir J. 2020 Apr 16;55(4):2000607. doi: 10.1183/13993003.00607-2020. Print 2020 Apr.

    PMID: 32269085RESULT

  • Neto AS, Pereira VG, Esposito DC, Damasceno MC, Schultz MJ. Neuromuscular blocking agents in patients with acute respiratory distress syndrome: a summary of the current evidence from three randomized controlled trials. Ann Intensive Care. 2012 Jul 26;2(1):33. doi: 10.1186/2110-5820-2-33.

    PMID: 22835162RESULT

  • Papazian L, Forel JM, Gacouin A, Penot-Ragon C, Perrin G, Loundou A, Jaber S, Arnal JM, Perez D, Seghboyan JM, Constantin JM, Courant P, Lefrant JY, Guerin C, Prat G, Morange S, Roch A; ACURASYS Study Investigators. Neuromuscular blockers in early acute respiratory distress syndrome. N Engl J Med. 2010 Sep 16;363(12):1107-16. doi: 10.1056/NEJMoa1005372.

    PMID: 20843245RESULT

  • Hohmann F, Wedekind L, Grundeis F, Dickel S, Frank J, Golinski M, Griesel M, Grimm C, Herchenhahn C, Kramer A, Metzendorf MI, Moerer O, Olbrich N, Thieme V, Vieler A, Fichtner F, Burns J, Laudi S. Early spontaneous breathing for acute respiratory distress syndrome in individuals with COVID-19. Cochrane Database Syst Rev. 2022 Jun 29;6(6):CD015077. doi: 10.1002/14651858.CD015077.

    PMID: 35767435DERIVED

MeSH Terms

Interventions

Muscle Relaxation

Intervention Hierarchy (Ancestors)

Muscle ContractionMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

June 8, 2021

First Posted

June 11, 2021

Study Start

August 1, 2021

Primary Completion

March 1, 2022

Study Completion

August 1, 2022

Last Updated

December 24, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

EG(1)