Sars-CoV2 Clinical Trial
— PRON-COVIDOfficial title:
Study of the Feasibility and Usefulness of the Prone Position in Patients With Respiratory Distress From Covid-19 Not Intubated, in Spontaneous Breath in Oxygen Therapy or Cpap
NCT number | NCT04365959 |
Other study ID # | PRON-COVID |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 20, 2020 |
Est. completion date | May 9, 2020 |
Verified date | April 2022 |
Source | University of Milano Bicocca |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The prone position during mechanical ventilation in patients with Acute Respiratory Distress Syndrome (ARDS) is able to improve oxygenation and thus reduce mortality. The objective of the study is to evaluate the ability of the prone position to increase the oxygenation of the patient with SARS-cov-2 pneumonia.
Status | Completed |
Enrollment | 56 |
Est. completion date | May 9, 2020 |
Est. primary completion date | April 9, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Age> = 18 years old or <= 75 years old - Diagnosis of COVID related pneumonia requiring oxygen or CPAP support Exclusion Criteria: - pregnant patients - patients with impaired consciousness and / or uncooperative - patients with NYHA class> II - patients with high proBNP - patients with COPD - contraindications evidenced by the physicians |
Country | Name | City | State |
---|---|---|---|
Italy | ASST Monza | Monza | MB |
Lead Sponsor | Collaborator |
---|---|
University of Milano Bicocca |
Italy,
Albert RK, Hubmayr RD. The prone position eliminates compression of the lungs by the heart. Am J Respir Crit Care Med. 2000 May;161(5):1660-5. — View Citation
Albert RK, Leasa D, Sanderson M, Robertson HT, Hlastala MP. The prone position improves arterial oxygenation and reduces shunt in oleic-acid-induced acute lung injury. Am Rev Respir Dis. 1987 Mar;135(3):628-33. — View Citation
Bouadma L, Lescure FX, Lucet JC, Yazdanpanah Y, Timsit JF. Severe SARS-CoV-2 infections: practical considerations and management strategy for intensivists. Intensive Care Med. 2020 Apr;46(4):579-582. doi: 10.1007/s00134-020-05967-x. Epub 2020 Feb 26. — View Citation
Broccard AF, Shapiro RS, Schmitz LL, Ravenscraft SA, Marini JJ. Influence of prone position on the extent and distribution of lung injury in a high tidal volume oleic acid model of acute respiratory distress syndrome. Crit Care Med. 1997 Jan;25(1):16-27. — View Citation
Guérin C, Reignier J, Richard JC, Beuret P, Gacouin A, Boulain T, Mercier E, Badet M, Mercat A, Baudin O, Clavel M, Chatellier D, Jaber S, Rosselli S, Mancebo J, Sirodot M, Hilbert G, Bengler C, Richecoeur J, Gainnier M, Bayle F, Bourdin G, Leray V, Girard R, Baboi L, Ayzac L; PROSEVA Study Group. Prone positioning in severe acute respiratory distress syndrome. N Engl J Med. 2013 Jun 6;368(23):2159-68. doi: 10.1056/NEJMoa1214103. Epub 2013 May 20. — View Citation
Hopkins SR, Henderson AC, Levin DL, Yamada K, Arai T, Buxton RB, Prisk GK. Vertical gradients in regional lung density and perfusion in the supine human lung: the Slinky effect. J Appl Physiol (1985). 2007 Jul;103(1):240-8. Epub 2007 Mar 29. — View Citation
Mure M, Glenny RW, Domino KB, Hlastala MP. Pulmonary gas exchange improves in the prone position with abdominal distension. Am J Respir Crit Care Med. 1998 Jun;157(6 Pt 1):1785-90. — View Citation
Pappert D, Rossaint R, Slama K, Grüning T, Falke KJ. Influence of positioning on ventilation-perfusion relationships in severe adult respiratory distress syndrome. Chest. 1994 Nov;106(5):1511-6. — View Citation
Scaravilli V, Grasselli G, Castagna L, Zanella A, Isgrò S, Lucchini A, Patroniti N, Bellani G, Pesenti A. Prone positioning improves oxygenation in spontaneously breathing nonintubated patients with hypoxemic acute respiratory failure: A retrospective study. J Crit Care. 2015 Dec;30(6):1390-4. doi: 10.1016/j.jcrc.2015.07.008. Epub 2015 Jul 16. — View Citation
Valenza F, Guglielmi M, Maffioletti M, Tedesco C, Maccagni P, Fossali T, Aletti G, Porro GA, Irace M, Carlesso E, Carboni N, Lazzerini M, Gattinoni L. Prone position delays the progression of ventilator-induced lung injury in rats: does lung strain distribution play a role? Crit Care Med. 2005 Feb;33(2):361-7. — View Citation
Valter C, Christensen AM, Tollund C, Schønemann NK. Response to the prone position in spontaneously breathing patients with hypoxemic respiratory failure. Acta Anaesthesiol Scand. 2003 Apr;47(4):416-8. — View Citation
Yang X, Yu Y, Xu J, Shu H, Xia J, Liu H, Wu Y, Zhang L, Yu Z, Fang M, Yu T, Wang Y, Pan S, Zou X, Yuan S, Shang Y. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020 May;8(5):475-481. doi: 10.1016/S2213-2600(20)30079-5. Epub 2020 Feb 24. Erratum in: Lancet Respir Med. 2020 Apr;8(4):e26. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of patients in whom the prone position caused an increase in oxygenation | Measure the ability of the prone position to increase the oxygenation of the patient with SARS-cov-2 pneumonia as a lung recruitment index. | Until patient discharge from the hospital (approximately 1 month after enrollment) | |
Secondary | The feasibility of prone position | Measure the feasibility of the prone position in terms of patient comfort and health resources in a context of a national health emergency. | Until patient discharge from the hospital (approximately 1 month after enrollment) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT04446065 -
Previfenon® as Chemoprophylaxis of COVID-19 in Health Workers
|
Phase 2/Phase 3 | |
Completed |
NCT04419025 -
Efficacy of N-Acetylcysteine (NAC) in Preventing COVID-19 From Progressing to Severe Disease
|
Phase 2 | |
Not yet recruiting |
NCT04400019 -
Prevention of COVID19 Infection in Nursing Homes by Chemoprophylaxis With Hydroxychloroquine (PREVICHARM)
|
Phase 2/Phase 3 | |
Completed |
NCT04463004 -
Mavrilimumab to Reduce Progression of Acute Respiratory Failure in COVID-19 Pneumonia and Systemic Hyper-inflammation
|
Phase 2 | |
Completed |
NCT04446429 -
Anti-Androgen Treatment for COVID-19
|
N/A | |
Completed |
NCT04402957 -
LSALT Peptide vs. Placebo to Prevent ARDS and Acute Kidney Injury in Patients Infected With SARS-CoV-2 (COVID-19)
|
Phase 2 | |
Recruiting |
NCT04441372 -
Prognostication of Oxygen Requirement in Non-severe SARS-CoV-2 Infection
|
||
Recruiting |
NCT04581148 -
SARS-CoV2 Antibodies in Pediatric Patients (COVID-19)
|
||
Terminated |
NCT04371978 -
Efficacy and Safety of Dipeptidyl Peptidase-4 Inhibitors in Diabetic Patients With Established COVID-19
|
Phase 3 | |
Completed |
NCT04530604 -
Defibrotide Therapy for SARS-CoV2 (COVID-19) Acute Respiratory Distress Syndrome (ARDS)
|
Phase 1 | |
Active, not recruiting |
NCT04635605 -
Methylene Blue Treatment of COVID-19
|
Phase 2 | |
Recruiting |
NCT04395599 -
Risk of Air Contamination During Visceral Surgery in COVID19 Patients
|
N/A | |
Recruiting |
NCT04472585 -
Efficacy of Subcutaneous Ivermectin With or Without Zinc in COVID-19 Patients
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT04411433 -
Efficacy and Safety of Hydroxychloroquine and Favipiravir in the Treatment of Mild to Moderate COVID-19
|
Phase 3 | |
Completed |
NCT04359706 -
Bacterial and Fungal Microbiota of Patients With Severe Viral Pneumonia With COVID-19
|
||
Recruiting |
NCT04395794 -
SARS-CoV-2 Disguise Study
|
||
Completed |
NCT04386551 -
Detection of COVID-19 in Saliva Collection
|
||
Recruiting |
NCT04403269 -
NORMAL HUMAN IMMUNOGLOBULINS (IVIG) IN PATIENTS AGED 75 YEARS AND OVER, COVID-19 WITH SEVERE ACUTE RESPIRATORY FAILURE
|
Phase 2 | |
Withdrawn |
NCT04379492 -
A Study of Hydroxycholoroquine Compared to Placebo as Treatment for People With COVID-19
|
Phase 2 | |
Completed |
NCT04366934 -
Study of the Pathogenesis of Olfactory Disorders in COVID-19
|