scholarly journals Early Anti-SARS-CoV-2 Convalescent Plasma in Patients Admitted for COVID-19: A Randomized Phase II Clinical Trial

2020 ◽  
Author(s):  
María Elvira Balcells ◽  
Luis Rojas ◽  
Nicole Le Corre ◽  
Constanza Martínez-Valdebenito ◽  
María Elena Ceballos ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Mechanical Ventilation ◽  
Clearance Rate ◽  
Primary Outcome ◽  
Group Versus ◽  
Hospital Length ◽  
Hospital Length Of Stay ◽  
Open Label ◽  
Serious Adverse Events ◽  
Academic Center

Background: Convalescent plasma (CP), despite limited evidence on its efficacy, is being widely used as a compassionate therapy for hospitalized patients with COVID-19. We aimed to evaluate the efficacy and safety of early CP therapy in COVID-19 progression. Methods: Open-label, single-center, randomized clinical trial performed in an academic center in Santiago, Chile from May 10, 2020, to July 18, 2020, with final follow-up August 17, 2020. The trial included patients hospitalized within the first 7 days of COVID-19 symptoms onset, presenting risk factors for illness progression and not on mechanical ventilation. The intervention consisted in immediate CP (early plasma group) versus no CP unless developing pre-specified criteria of deterioration (deferred plasma group). Additional standard treatment was allowed in both arms. The primary outcome was a composite of mechanical ventilation, hospitalization for >14 days or death. Key secondary outcomes included: time to respiratory failure, days of mechanical ventilation, hospital length-of-stay, mortality at 30 days, and SARS-CoV-2 RT-PCR clearance rate. Results: Of 58 randomized patients (mean age, 65.8 years, 50% male), 57 (98.3%) completed the trial. A total of 13 (43.3%) participants from the deferred group received plasma based on clinical aggravation. We found no benefit in the primary outcome (32.1% vs 33.3%, OR 0.95, 95% CI 0.32-2.84, p>0.99) in the early versus deferred CP group. In-hospital mortality rate was 17.9% vs 6.7% (OR 3.04, 95% CI 0.54-17.2, p=0.25), mechanical ventilation 17.9% vs 6.7% (OR 3.04, 95% CI 0.54-17.2, p=0.25), and prolonged hospitalization 21.4% vs 30% (OR 0.64, 95%CI, 0.19-2.1, p=0.55) in early versus deferred CP group, respectively. Viral clearance rate on day 3 (26% vs 8%, p=0.20) and day 7 (38% vs 19%, p=0.37) did not differ between groups. Two patients experienced serious adverse events within 6 or less hours after plasma transfusion. Conclusion: Immediate addition of CP therapy in early stages of COVID-19 -compared to its use only in case of patient deterioration- did not confer benefits in mortality, length of hospitalization or mechanical ventilation requirement.

scholarly journals Early versus deferred anti-SARS-CoV-2 convalescent plasma in patients admitted for COVID-19: A randomized phase II clinical trial

PLoS Medicine ◽  
2021 ◽  
Vol 18 (3) ◽  
pp. e1003415
Author(s):  
María Elvira Balcells ◽  
Luis Rojas ◽  
Nicole Le Corre ◽  
Constanza Martínez-Valdebenito ◽  
María Elena Ceballos ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Mechanical Ventilation ◽  
Clearance Rate ◽  
Neutralizing Antibodies ◽  
Statistical Power ◽  
Primary Outcome ◽  
Medical Center ◽  
Academic Medical Center ◽  
Group Versus ◽  
Hospital Length Of Stay

Background Convalescent plasma (CP), despite limited evidence on its efficacy, is being widely used as a compassionate therapy for hospitalized patients with COVID-19. We aimed to evaluate the efficacy and safety of early CP therapy in COVID-19 progression. Methods and findings The study was an open-label, single-center randomized clinical trial performed in an academic medical center in Santiago, Chile, from May 10, 2020, to July 18, 2020, with final follow-up until August 17, 2020. The trial included patients hospitalized within the first 7 days of COVID-19 symptom onset, presenting risk factors for illness progression and not on mechanical ventilation. The intervention consisted of immediate CP (early plasma group) versus no CP unless developing prespecified criteria of deterioration (deferred plasma group). Additional standard treatment was allowed in both arms. The primary outcome was a composite of mechanical ventilation, hospitalization for >14 days, or death. The key secondary outcomes included time to respiratory failure, days of mechanical ventilation, hospital length of stay, mortality at 30 days, and SARS-CoV-2 real-time PCR clearance rate. Of 58 randomized patients (mean age, 65.8 years; 50% male), 57 (98.3%) completed the trial. A total of 13 (43.3%) participants from the deferred group received plasma based on clinical aggravation. We failed to find benefit in the primary outcome (32.1% versus 33.3%, odds ratio [OR] 0.95, 95% CI 0.32–2.84, p > 0.999) in the early versus deferred CP group. The in-hospital mortality rate was 17.9% versus 6.7% (OR 3.04, 95% CI 0.54–17.17 p = 0.246), mechanical ventilation 17.9% versus 6.7% (OR 3.04, 95% CI 0.54–17.17, p = 0.246), and prolonged hospitalization 21.4% versus 30.0% (OR 0.64, 95% CI, 0.19–2.10, p = 0.554) in the early versus deferred CP group, respectively. The viral clearance rate on day 3 (26% versus 8%, p = 0.204) and day 7 (38% versus 19%, p = 0.374) did not differ between groups. Two patients experienced serious adverse events within 6 hours after plasma transfusion. The main limitation of this study is the lack of statistical power to detect a smaller but clinically relevant therapeutic effect of CP, as well as not having confirmed neutralizing antibodies in donor before plasma infusion. Conclusions In the present study, we failed to find evidence of benefit in mortality, length of hospitalization, or mechanical ventilation requirement by immediate addition of CP therapy in the early stages of COVID-19 compared to its use only in case of patient deterioration. Trial registration NCT04375098.

scholarly journals 562. Tocilizumab for the Treatment of Severe COVID-19: A Retrospective, Multi-Center, Case-Matched Series

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S346-S346
Author(s):  
Sarah Norman ◽  
Sara Jones ◽  
David Reeves ◽  
Christian Cheatham
Keyword(s):  
Mechanical Ventilation ◽  
Length Of Stay ◽  
Hospital Mortality ◽  
Primary Outcome ◽  
Fungal Infections ◽  
Hospital Length ◽  
Hospitalized Patients ◽  
Hospital Length Of Stay ◽  
Matched Design ◽  
Median Hospital

Abstract Background At the time of this writing, there is no FDA approved medication for the treatment of COVID-19. One medication currently under investigation for COVID-19 treatment is tocilizumab, an interleukin-6 (IL-6) inhibitor. It has been shown there are increased levels of cytokines including IL-6 in severe COVID-19 hospitalized patients attributed to cytokine release syndrome (CRS). Therefore, inhibition of IL-6 receptors may lead to a reduction in cytokines and prevent progression of CRS. The purpose of this retrospective study is to utilize a case-matched design to investigate clinical outcomes associated with the use of tocilizumab in severe COVID-19 hospitalized patients. Methods This was a retrospective, multi-center, case-matched series matched 1:1 on age, BMI, and days since symptom onset. Inclusion criteria included ≥ 18 years of age, laboratory confirmed positive SARS-CoV-2 result, admitted to a community hospital from March 1st – May 8th, 2020, and received tocilizumab while admitted. The primary outcome was in-hospital mortality. Secondary outcomes included hospital length of stay, total mechanical ventilation days, mechanical ventilation mortality, and incidence of secondary bacterial or fungal infections. Results The following results are presented as tocilizumab vs control respectively. The primary outcome of in-hospital mortality for tocilizumab (n=26) vs control (n=26) was 10 (38%) vs 11 (42%) patients, p=0.777. The median hospital length of stay for tocilizumab vs control was 14 vs 11 days, p=0.275. The median days of mechanical ventilation for tocilizumab (n=21) vs control (n=15) was 8 vs 7 days, p=0.139, and the mechanical ventilation mortality was 10 (48%) vs 9 (60%) patients, p=0.463. In the tocilizumab group, for those expired (n=10) vs alive (n=16), 10 (100%) vs 7 (50%) patients respectively had a peak ferritin > 600 ng/mL, and 6 (60%) vs 8 (50%) patients had a peak D-dimer > 2,000 ng/mL. The incidence of secondary bacterial or fungal infections within 7 days of tocilizumab administration occurred in 5 (19%) patients. Conclusion These findings suggest that tocilizumab may be a beneficial treatment modality for severe COVID-19 patients. Larger, prospective, placebo-controlled trials are needed to further validate results. Disclosures Christian Cheatham, PharmD, BCIDP, Antimicrobial Resistance Solutions (Shareholder)

scholarly journals Effects of Methylprednisolone on Ventilator-Free Days in Mechanically Ventilated Patients with Acute Respiratory Distress Syndrome and COVID-19

2021 ◽  
Author(s):  
Mohamed Badr ◽  
Bruno De Oliveira ◽  
Khaled Abdallah ◽  
Ashraf Nadeem ◽  
Yeldho Varghese ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Acute Respiratory Distress Syndrome ◽  
Length Of Stay ◽  
Competing Risks ◽  
Primary Outcome ◽  
Distress Syndrome ◽  
Invasive Mechanical Ventilation ◽  
Hospital Length ◽  
Blood Cultures ◽  
Hospital Length Of Stay

Objectives: There are limited data regarding the efficacy of methylprednisolone in patients with acute respiratory distress syndrome (ARDS) due to coronavirus disease 2019 (COVID-19) requiring invasive mechanical ventilation. We aimed to determine whether methylprednisolone increases the number of ventilator-free days (VFDs) among these patients. Design: Retrospective single-center study Setting: Intensive care unit Patients: All patients with ARDS due to confirmed SARS-CoV-2 infection and requiring invasive mechanical ventilation between 1 March and 29 May 2020 were included Interventions: None Measurements and Main Results: The primary outcome was ventilator-free days (VFDs) during the first 28 days, defined as being alive and free from mechanical ventilation. The primary outcome was analyzed with competing-risks regression based on Fine and Gray’s proportional subhazards model. Death before day 28 was considered to be the competing event. A total of 77 patients met the inclusion criteria. Thirty-two patients (41.6%) received methylprednisolone. The median dose was 1 mg.kg-1 (IQR: 1-1.3 mg.kg-1) and median duration of 5 days (IQR:5-7 days). Patients who received methylprednisolone had a mean 18.8 VFDs (95% CI, 16.6-20.9) during the first 28 days vs. 14.2 VFDs (95% CI, 12.6-16.7) in patients who did not receive methylprednisolone (difference, 4.61; 95% CI, 1.10-8.12; P = 0.001). In the multivariable competing-risks regression analysis and after adjusting for potential confounders (ventilator settings, prone position, organ failure support, severity of the disease, tocilizumab, and inflammatory markers), methylprednisolone was independently associated with a higher number of VFDs (subhazards ratio: 0.10, 95%CI: 0.02-0.45; p=0.003). Hospital mortality did not differ between the two groups (31.2% vs. 28.9%, p=0.82). Hospital length of stay was significantly shorter in the methylprednisolone group (24 days [IQR:15-41 days] vs. 37 days [IQR:23-52 days], p=0.046). The incidence of positive blood cultures was higher in patients who received methylprednisolone (37.5% vs. 17.8%, p=0.052). However, 91% of patients who received methylprednisolone also received tocilizumab. The number of days with hyperglycemia was similar in the two groups. Conclusions: Methylprednisolone was independently associated with increased VFDs and shortened hospital length of stay. The combination of methylprednisolone and tocilizumab was associated with a higher rate of positive blood cultures. Further trials are needed to evaluate the benefits and safety of methylprednisolone in moderate or severe COVID-19 ARDS.

scholarly journals 71. Use of Intravenous Immunoglobulin Therapy Reduces Progression to Mechanical Ventilation in COVID-19 Patients with Moderate to Severe Hypoxia

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S166-S166
Author(s):  
George Sakoulas ◽  
Matthew Geriak ◽  
Ravina Kullar ◽  
Kris Greenwood ◽  
Mackenzie Habib ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Length Of Stay ◽  
Intravenous Immunoglobulin ◽  
Group Versus ◽  
Composite Endpoint ◽  
Hospital Length ◽  
Hospital Length Of Stay ◽  
Fisher Exact Test ◽  
Intravenous Immunoglobulin Therapy ◽  
Exact Test

Abstract Background The majority of COVID-19 morbidity and mortality occurs in patients who progress to mechanical ventilation. Therefore, therapeutic interventions targeting the mitigation of this complication would markedly improve outcomes and reduce healthcare utilization. Methods Patients with COVID-19 from two hospitals in San Diego, California were randomized at a 1:1 ratio to receive standard of care (SOC) plus intravenous immunoglobulin (IVIG) at 0.5 g/kg/day x 3 days with solumedrol 40 mg 30 minutes before infusion (IVIG group) versus SOC alone. The primary composite endpoint was receipt of mechanical ventilation or death before receiving ventilation. Patients were followed until discharge to home or up to 30 days from time of enrollment. Results Sixteen patients received IVIG plus SOC and 17 SOC alone. The median age was 54 years for SOC and 57 years for IVIG. Median time from hospital admission to study enrollment was 1 day (range 0–4) for SOC and 2 days (range 0–8) for IVIG. APACHE II scores and Charlson comorbidity indices were similar for IVIG and SOC (median 8 vs 7 and 2 for both, respectively). Seven SOC patients achieved the composite endpoint (6 ventilated, 1 death) versus 2 IVIG patients (2 ventilated), p=0.12, Fisher exact test. Among the subgroup with an estimated A-a gradient of >200 mm Hg at time of enrollment, the IVIG group showed a lower rate of progression to the composite endpoint (2/14 vs 7/12, p=0.04 Fisher exact test), shorter median hospital length (11 vs 24 days, p=0.001 Mann Whitney U), and shorter median intensive care unit (ICU) stay (3 vs 13 days, p=0.005 Mann Whitey U). Conclusion This small, prospective, randomized, open-label study showed that when administered to hypoxic non-ventilated COVID-19 patients with an A-a gradient of >200 mm Hg (corresponding to a requirement of 6 liters O2 via nasal cannula to achieve an SpO2 of 92%), IVIG significantly decreased the rates of progression to mechanical ventilation, ICU length of stay, and total hospital length of stay. A Phase 3 prospective, randomized, placebo-controlled, multicenter trial is underway to further validate these findings. Disclosures George Sakoulas, MD, Octapharma (Grant/Research Support, Scientific Research Study Investigator)

scholarly journals Effects of Methylprednisolone on Ventilator-Free Days in Mechanically Ventilated Patients with Acute Respiratory Distress Syndrome and COVID-19: A Retrospective Study

2021 ◽  
Vol 10 (4) ◽  
pp. 760
Author(s):  
Mohamed Badr ◽  
Bruno De Oliveira ◽  
Khaled Abdallah ◽  
Ashraf Nadeem ◽  
Yeldho Varghese ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Acute Respiratory Distress Syndrome ◽  
Length Of Stay ◽  
Competing Risks ◽  
Primary Outcome ◽  
Distress Syndrome ◽  
Invasive Mechanical Ventilation ◽  
Hospital Length ◽  
Blood Cultures ◽  
Hospital Length Of Stay

Objectives: There are limited data regarding the efficacy of methylprednisolone in patients with acute respiratory distress syndrome (ARDS) due to coronavirus disease 2019 (COVID-19) requiring invasive mechanical ventilation. We aimed to determine whether methylprednisolone is associated with increases in the number of ventilator-free days (VFDs) among these patients. Design: Retrospective single-center study. Setting: Intensive care unit. Patients: All patients with ARDS due to confirmed SARS-CoV-2 infection and requiring invasive mechanical ventilation between 1 March and 29 May 2020 were included. Interventions: None. Measurements and Main Results: The primary outcome was ventilator-free days (VFDs) for the first 28 days. Defined as being alive and free from mechanical ventilation. The primary outcome was analyzed with competing-risks regression based on Fine and Gray’s proportional sub hazards model. Death before day 28 was considered to be the competing event. A total of 77 patients met the inclusion criteria. Thirty-two patients (41.6%) received methylprednisolone. The median dose was 1 mg·kg−1 (IQR: 1–1.3 mg·kg−1) and median duration for 5 days (IQR: 5–7 days). Patients who received methylprednisolone had a mean 18.8 VFDs (95% CI, 16.6–20.9) during the first 28 days vs. 14.2 VFDs (95% CI, 12.6–16.7) in patients who did not receive methylprednisolone (difference, 4.61, 95% CI, 1.10–8.12, p = 0.001). In the multivariable competing-risks regression analysis and after adjusting for potential confounders (ventilator settings, prone position, organ failure support, severity of the disease, tocilizumab, and inflammatory markers), methylprednisolone was independently associated with a higher number of VFDs (subhazards ratio: 0.10, 95% CI: 0.02–0.45, p = 0.003). Hospital mortality did not differ between the two groups (31.2% vs. 28.9%, p = 0.82). Hospital length of stay was significantly shorter in the methylprednisolone group (24 days [IQR: 15–41 days] vs. 37 days [IQR: 23–52 days], p = 0.046). The incidence of positive blood cultures was higher in patients who received methylprednisolone (37.5% vs. 17.8%, p = 0.052). However, 81% of patients who received methylprednisolone also received tocilizumab. The number of days with hyperglycemia was similar in the two groups. Conclusions: Methylprednisolone was independently associated with increased VFDs and shortened hospital length of stay. The combination of methylprednisolone and tocilizumab was associated with a higher rate of positive blood cultures. Further trials are needed to evaluate the benefits and safety of methylprednisolone in moderate or severe COVID-19 ARDS.

scholarly journals Clinical Characteristics and Outcomes of Critically Ill Mechanically Ventilated Patients Receiving Adjunctive Ketamine for Sedation: an Investigator-Driven, Open-Label, Randomized, Controlled Trial

2021 ◽  
Author(s):  
Marwa Amer ◽  
Mohammed Bawazeer ◽  
Khalid Maghrabi ◽  
Kamel Alshaikh ◽  
Mohammad Shaban ◽  
...  
Keyword(s):  
Clinical Characteristics ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Hospital Length ◽  
Hospital Length Of Stay ◽  
Adherence Rate ◽  
Consent Rate ◽  
Open Label ◽  
Icu Patients ◽  
Mechanically Ventilated

AbstractBackgroundKetamine has been shown to decrease sedative requirements in intensive care unit (ICU). Randomized trials are lacking on patient-centered outcomes. We aimed to compare the clinical characteristics and outcomes of mechanically ventilated adult ICU patients receiving ketamine as an adjunct analgosedative with those receiving standard of care (SOC) alone. We also described the feasibility during COVID-19 pandemic.MethodsIn this randomized, open-label trial either ketamine or SOC, in a 1:1 ratio, was administered to patients who were intubated within 24 hours (medical, surgical, or transplant/oncology ICUs), expected to require mechanical ventilation (MV) for the next calendar day, and had the institutional pain and sedation protocol initiated. Ketamine infusion was 2 μg/kg/min on day 1 and 1 μg/kg/min on day 2. The primary outcome was the 28-day MV duration and ventilator-free days as co-primary outcome. Cox-proportional regression analysis was used to assess factors associated with probability for weaning off MV.ResultsA total of 83 patients (43 in SOC and 40 in ketamine) were included. Demographics were balanced between the groups. The median duration of MV was not significantly different between the groups [median (interquartile range): 7 (3-9.25) for ketamine and 5 (2-8) for SOC, p= 0.15]. The median ventilation-free days was 19 days (IQR 0-24.75) in the ketamine and 19 days (IQR 0-24) in the SOC (p=0.70). Surgical and transplant/oncology ICU patients had a higher probability of weaning off MV than those in medical ICU [hazard ratio (95% confidence interval): 2.09 (1.06–4.14) for surgical ICU, 2.11 (1.02–4.35) for transplant/oncology ICU]. More patient was at goal RASS in ketamine compared to SOC. The sedatives and vasopressors cumulative doses were similar between the two arms at 48 hours. We found no difference in 28-day mortality rate, ICU and hospital length of stay, and hemodynamic changes. The consent rate was adequate and the protocol adherence rate was 97.5%.ConclusionsKetamine as an adjunct agent for sedation did not decrease the duration of MV and appeared to be safe, feasible, and effective in subgroups of ICU patients. No effect was noted in sedative and pressors requirements, or on hemodynamics.Trial registrationClinicalTrials.gov: NCT04075006 and current-controlled trials: ISRCTN14730035

scholarly journals Effectiveness of a digital therapeutic as adjunct to treatment with medication in pediatric ADHD

2021 ◽  
Vol 4 (1) ◽  
Author(s):  
Scott H. Kollins ◽  
Ann Childress ◽  
Andrew C. Heusser ◽  
Jacqueline Lutz
Keyword(s):  
Video Game ◽  
Primary Outcome ◽  
Rating Scale ◽  
Stimulant Medication ◽  
Additional Treatment ◽  
Adhd Medication ◽  
Open Label ◽  
Serious Adverse Events ◽  
Treatment Benefit ◽  
Hyperactivity Disorder

AbstractSTARS-Adjunct was a multicenter, open-label effectiveness study of AKL-T01, an app and video-game-based treatment for inattention, as an adjunct to pharmacotherapy in 8–14-year-old children with attention-deficit/hyperactivity disorder (ADHD) on stimulant medication (n = 130) or not on any ADHD medication (n = 76). Children used AKL-T01 for 4 weeks, followed by a 4-week pause and another 4-week treatment. The primary outcome was change in ADHD-related impairment (Impairment Rating Scale (IRS)) after 4 weeks. Secondary outcomes included changes in IRS, ADHD Rating Scale (ADHD-RS). and Clinical Global Impressions Scale—Improvement (CGI-I) on days 28, 56, and 84. IRS significantly improved in both cohorts (On Stimulants: −0.7, p < 0.001; No Stimulants: −0.5, p < 0.001) after 4 weeks. IRS, ADHD-RS, and CGI-I remained stable during the pause and improved with a second treatment period. The treatment was well-tolerated with no serious adverse events. STARS-Adjunct extends AKL-T01’s body of evidence to a medication-treated pediatric ADHD population, and suggests additional treatment benefit.

scholarly journals Cardiac Injuries at Estonian Major Trauma Facilities: A 23-year Perspective

2018 ◽  
Vol 108 (2) ◽  
pp. 159-163 ◽  
Author(s):  
M. Einberg ◽  
S. Saar ◽  
A. Seljanko ◽  
A. Lomp ◽  
U. Lepner ◽  
...  
Keyword(s):  
Length Of Stay ◽  
Primary Outcome ◽  
Major Trauma ◽  
Alcohol Intoxication ◽  
Cardiac Injury ◽  
Hospital Length ◽  
Hospital Length Of Stay ◽  
Cardiac Trauma ◽  
Icd 10 ◽  
Overall Mortality

Background and Aims: Cardiac injuries are highly lethal lesions following trauma and most of the patients decease in pre-hospital settings. However, studies on cardiac trauma in Estonia are scarce. Thus, we set out to study cardiac injuries admitted to Estonian major trauma facilities during 23 years of Estonian independence. Materials and Methods: After the ethics review board approval, all consecutive patients with cardiac injuries per ICD-9 (861.0 and 861.1) and ICD-10 codes (S.26) admitted to the major trauma facilities between 1 January 1993 and 31 July 2016 were retrospectively reviewed. Cardiac contusions were excluded. Data collected included demographics, injury profile, and in-hospital outcomes. Primary outcome was mortality. Secondary outcomes were cardiac injury profile and hospital length of stay. Results: During the study period, 37 patients were included. Mean age was 33.1 ± 12.0 years and 92% were male. Penetrating and blunt trauma accounted for 89% and 11% of the cases, respectively. Thoracotomy and sternotomy rates for cardiac repair were 80% and 20%, respectively. Most frequently injured cardiac chamber was left ventricle at 49% followed by right ventricle, right atrium, and left atrium at 34%, 17%, and 3% of the patients, respectively. Multi-chamber injury was observed at 5% of the cases. Overall hospital length of stay was 13.5 ± 16.7 days. Overall mortality was 22% (n = 8) with uniformly fatal outcomes following left atrial and multi-chamber injuries. Conclusion: Overall, 37 patients with cardiac injuries were hospitalized to national major trauma facilities during the 23-year study period. The overall in-hospital mortality was 22% comparing favorably with previous reports. Risk factors for mortality were initial Glasgow Coma Scale < 9, pre-hospital cardiopulmonary resuscitation, and alcohol intoxication.

scholarly journals Awake Prone Position in Hypoxemic Patients with Coronavirus Disease 19 (COVI-PRONE): A Study protocol and Statistical Analysis Plan for Randomized Clinical Trial

2021 ◽  
Author(s):  
Zainab Al Duhailib ◽  
Yaseen Arabi ◽  
Sarah Culgin ◽  
Jason Weatherald ◽  
Ken Kuljit S. Parhar ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Prone Position ◽  
Controlled Trial ◽  
Invasive Mechanical Ventilation ◽  
Target Population ◽  
Altered Mental Status ◽  
Hemodynamic Instability ◽  
Hospital Length Of Stay ◽  
Prone Positioning ◽  
Serious Adverse Events

Background Coronavirus disease 2019 (COVID-19), may progress to respiratory failure requiring invasive mechanical ventilation. Due to ventilator shortage and healthcare systems strain, affordable interventions such as awake prone positioning has been used to improve oxygenation, however, the effect of this intervention on patient-important outcomes is uncertain. The COVI-PRONE trial aims to determine if awake prone positioning in hypoxemic COVID-19 patients reduces the need for invasive mechanical ventilation. Study design A pragmatic, multicenter, international, parallel-group, and stratified randomized controlled trial, aiming to enrol 400 hospitalized adults with COVID-19. Participants The target population is hospitalized adults with confirmed or suspected COVID-19, hypoxemia that requires ≥40% oxygen or ≥ 5 L/min by nasal cannula, and abnormal chest x-ray. We will exclude patients with any of the following: immediate need for intubation; altered mental status; contraindication to prone positioning; hemodynamic instability; body mass index > 40 kg/m2; third trimester pregnancy; do not intubate status; previous enrolment or intubation within the same hospital admission; and prone positioning for more than one day prior to randomization. Study intervention and control Following informed a priori or deferred consent, eligible patients will be centrally randomized to either the intervention arm (prone positioning) or standard of care (no prone positioning). Patients randomized to the prone position will be required to either self-prone or assist-prone for a total of eight to ten hours per day until they meet pre-specified stopping criteria. Study outcomes The primary outcome is invasive mechanical ventilation at 30-days of randomization. Other outcomes include mortality at 60 days, invasive and non-invasive mechanical ventilation free days at 30 days, hospital length of stay at 60 days, days alive and outside of the hospital at 60 days, complications of proning, and serious adverse events.

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