NCT04349618: VT4COVID

Ultraprotective Ventilation Without Extracorporeal Circulation During COVID 19 Pneumonia

Completed NA Last updated 10 December 2025

What this trial tests

NA trial testing PROTECTIVE VENTILATION in Acute Respiratory Distress Syndrome in 220 participants. Completed in 16 June 2022.

Timeline

15 April 2020

Primary endpoint
16 June 2022

16 June 2022

Quick facts

Lead sponsor	Hospices Civils de Lyon
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	220
Start date	15 April 2020
Primary completion	16 June 2022
Estimated completion	16 June 2022
Sites	11 locations across France

Drugs / interventions tested

• PROTECTIVE VENTILATION
• ULTRAPROTECTIVE VENTILATION

Conditions studied

• Acute Respiratory Distress Syndrome — all drugs for Acute Respiratory Distress Syndrome →
• COVID19 — all drugs for COVID19 →
• Sars-CoV2 — all drugs for Sars-CoV2 →
• Pneumonia — all drugs for Pneumonia →

Sponsor

Hospices Civils de Lyon — full company profile →

Who can join

18 and older, any sex, with Acute Respiratory Distress Syndrome or COVID19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Mortality of COVID-19 pneumonia with acute respiratory distress syndrome (ARDS) is extremely high in preliminary reports amounting to 50-60%. Duration of mechanical ventilation in these patients appears to exceed standard duration of mechanical ventilation in non-COVID-19 ARDS patients, suggesting that COVID-19 patients may be particularly at risk for ventilator-induced lung injury. Treatment of COVID-19 ARDS patients is to date mainly supportive with protective mechanical ventilation (ventilation with low tidal volume (VT) i.e. 6 ml/kg of predicted body weight (PBW) and plateau pressure control below 30 cm H2O).

Mechanical ventilation with VT reduction below 6 ml/kg PBW in ARDS may reduce alveolar strain, driving pressure and hence ventilator-induced lung injury. Investigators recently performed a multicenter pilot study on 34 moderately severe to severe ARDS patients. This study demonstrated that ultraprotective ventilation with ultra-low VT (≤4.2 ml/kg PBW) without extracorporeal circulation may be applied in approximately 2/3 of the patients, with a 4 cmH2O median reduction in driving pressure, at the price of transient episodes of severe acidosis in approximately 1/3 of the patients. Investigators hypothesized that ultraprotective ventilation without extracorporeal circulation may reduce the mortality at day-90 and increase the number of days free from mechanical ventilation (VFD) at day-60, as compared to protective ventilation.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Ultra-low tidal volume ventilation for COVID-19-related ARDS in France (VT4COVID): a multicentre, open-label, parallel-group, randomised trial.
   Richard JC, Terzi N, Yonis H, Chorfa F, et al · · 2023 · cited 16× · PMID 37453445 · DOI 10.1016/s2213-2600(23)00221-7
2. Outcomes Evaluated in Controlled Clinical Trials on the Management of COVID-19: A Methodological Systematic Review.
   Mathioudakis AG, Fally M, Hashad R, Kouta A, et al · · 2020 · cited 14× · PMID 33333777 · DOI 10.3390/life10120350
3. Open-label randomized controlled trial of ultra-low tidal ventilation without extracorporeal circulation in patients with COVID-19 pneumonia and moderate to severe ARDS: study protocol for the VT4COVID trial.
   Richard JC, Yonis H, Bitker L, Roche S, et al · · 2021 · cited 2× · PMID 34635128 · DOI 10.1186/s13063-021-05665-z
4. ESICM LIVES 2025
   · 2025