Characteristics and outcomes of Acute Respiratory Distress Syndrome related to COVID-19 in Belgian and French Intensive Care Units according to antiviral strategies. The COVADIS multicenter observational study
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Abstract
Background
Limited data are available for antiviral therapy efficacy especially for the most severe patients under mechanical ventilation suffering from Covid-19 related Acute Respiratory Distress Syndrome (ARDS).
Methods
Observational multicenter cohort of patients with moderate to severe Covid-19 ARDS, comparing antiviral strategies (none, hydroxychloroquine (HCQ), lopinavir/ritonavir (L/R), others (combination or remdesivir). The primary end-point was the day-28 ventilator free days (VFD), patients which died before d28 were considered as having 0 VFD. The variable was dichotomized in patients still ventilated or dead at day 28 vs patients being extubated and alive at day 28 (VFD = or >0).
Results
We analyzed 376 patients (80 with standard of care (SOC), 49 treated with L/R, 197 with HCQ, and 50 others). The median number of d28-VFD was 0 (IQR 0-13) and was different across the different groups (P=0.01), the SOC patients having the highest d28-VFD. A multivariate logistic regression including antiviral strategies, showed that age (OR 0.95 CI95%:0.93-0.98), male gender (OR 0.53 CI95%:0.31-0.93), Charlson score (OR 0.85 CI95%:0.73-0.99) and plateau pressure (OR 0.94 CI95%:0.88-0.99) were associated with having 0 d28-VFD whereas P/F ratio (OR 1.005 CI95%:1.001-1.010) was associated with having ≥1 d28-VFD (ie. being extubated and alive). Acute kidney injury (AKI) was frequent (64%), its incidence was different across the patients’ groups (P=0.01). In a post-hoc logistic multivariate regression apart from demographics characteristics and comorbidities, the use of L/R (administered to 81 of 376 patients was associated with occurrence of AKI (OR 2.07 CI95%:1.17-3.66) and need for renal replacement therapy (RRT).
Conclusion
In this observational study of moderate to severe Covid-19 ARDS patients, we did not observed a benefit of treating patients with any specific antiviral treatment. We observed an association between L/R treatment and occurrence of AKI and need for RRT.
Take home message
Any specific COVID-19 antiviral treatment is associated with higher ventilator free days at day 28 as compared to no antiviral treatment for patient in ICU under invasive mechanical ventilation. Lopinavir/ritonavir is associated with an increased risk of acute kidney injury.
Tweet
COVID-19: Insights from ARDS cohort: no signal of efficacy for antiviral treatments. Lopinavir/ritonavir may be associated with AKI and need for RRT.
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SciScore for 10.1101/2020.06.28.20141911: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement not detected. Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
No key resources detected.
Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:Finally, we highlight the limitations of our observational study: the patients were not randomized so that we cannot exclude indication bias although collected variables suggest high similarity across treatment strategies. …
SciScore for 10.1101/2020.06.28.20141911: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement not detected. Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
No key resources detected.
Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:Finally, we highlight the limitations of our observational study: the patients were not randomized so that we cannot exclude indication bias although collected variables suggest high similarity across treatment strategies. Non-measured confusion biases may exist as well. We did not collect severity score but these scores have been done to compare patients with different diseases in the ICU, and Charlson score, associated with gender and age, have been shown to predict mortality with good accuracy [33]. We have also some missing data which can impact our results. For reasons of lack of time during COVID-19 crisis, we limited strongly the numbers of collected variables so that we are not able to report important data such as the use of ACE inhibitors, or daily ventilator settings. But clinical significance of those factors is also a matter of debate [34]. Lastly, some of these patients have been included in other studies.
Results from TrialIdentifier: No clinical trial numbers were referenced.
Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a protocol registration statement.
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