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1.
PLoS One ; 16(10): e0258754, 2021.
Article in English | MEDLINE | ID: covidwho-1477539

ABSTRACT

Continuous positive airway pressure (CPAP) has been successfully applied to patients with COVID-19 to prevent endotracheal intubation. However, experience of CPAP application in pregnant women with acute respiratory failure (ARF) due to SARS-CoV-2 pneumonia is scarce. This study aimed to describe the natural history and outcome of ARF in a cohort of pregnant women with SARS-CoV-2 pneumonia, focusing on the feasibility of helmet CPAP (h-CPAP) application and the variables related to ARF worsening. A retrospective, observational study enrolling 41 consecutive pregnant women hospitalised for SARS-CoV-2 pneumonia in a tertiary care center between March 2020 and March 2021. h-CPAP was applied if arterial partial pressure of oxygen to fraction of inspired oxygen ratio (PaO2/FiO2) was inferior to 200 and/or patients had respiratory distress despite adequate oxygen supplementation. Characteristics of patients requiring h-CPAP vs those in room air or oxygen only were compared. Twenty-seven (66%) patients showed hypoxemic ARF requiring oxygen supplementation and h-CPAP was needed in 10 cases (24%). PaO2/FiO2 was significantly improved during h-CPAP application. The device was well-tolerated in all cases with no adverse events. Higher serum C reactive protein and more extensive (≥3 lobes) involvement at chest X-ray upon admission were observed in the h-CPAP group. Assessment of temporal distribution of cases showed a substantially increased rate of CPAP requirement during the third pandemic wave (January-March 2021). In conclusion, h-CPAP was feasible, safe, well-tolerated and improved oxygenation in pregnant women with moderate-to-severe ARF due to SARS-CoV-2 pneumonia. Moderate-to-severe ARF was more frequently observed during the third pandemic wave.


Subject(s)
COVID-19 , Continuous Positive Airway Pressure , Oxygen/administration & dosage , Pregnancy Complications, Infectious , Respiratory Insufficiency , SARS-CoV-2/metabolism , Tertiary Care Centers , Acute Disease , Adult , COVID-19/blood , COVID-19/therapy , Female , Humans , Oxygen/blood , Pregnancy , Pregnancy Complications, Infectious/blood , Pregnancy Complications, Infectious/therapy , Protein C/metabolism , Respiratory Insufficiency/blood , Respiratory Insufficiency/therapy , Retrospective Studies
2.
Eur Rev Med Pharmacol Sci ; 25(18): 5871-5875, 2021 Sep.
Article in English | MEDLINE | ID: covidwho-1451046

ABSTRACT

OBJECTIVE: Post-acute sequelae of SARS-CoV2 infection (PASC) are a novel terminology used to describe post-COVID persistent symptoms, mimicking somehow the previously described chronic fatigue syndrome (CFS). In this manuscript, we evaluated a therapeutical approach to address PASC-derived fatigue in a cohort of past-COVID-19 positive patients. PATIENTS AND METHODS: A number of 100 patients, previously diagnosed as COVID-19 positive subjects and meeting our eligibility criteria, was diagnosed having PASC-related fatigue. They were recruited in the study and treated with oxygen-ozone autohemotherapy (O2-O3-AHT), according to the SIOOT protocol. Patients' response to O2-O3-AHT and changes in fatigue were measured with the 7-scoring Fatigue Severity Scale (FSS), according to previously published protocols. RESULTS: Statistics assessed that the effects of O2-O3-AHT on fatigue reduced PASC symptoms by 67%, as a mean, in all the investigated cohort of patients (H = 148.4786 p < 0.0001) (Figure 1). Patients following O2-O3-AHT therapy, quite completely recovered for PASC-associated fatigue, a quote amounting to about two fifths (around 40%) of the whole cohort undergoing ozone treatment and despite most of patients were female subjects, the effect was not influenced by sex distribution (H = 0.7353, p = 0.39117). CONCLUSIONS: Ozone therapy is able to recover normal functionality and to relief pain and discomfort in the form of PASC-associated fatigue in at least 67% of patients suffering from post-COVID sequelae, aside from sex and age distribution.


Subject(s)
Blood Transfusion/methods , COVID-19/complications , Fatigue Syndrome, Chronic/etiology , Fatigue Syndrome, Chronic/therapy , Oxygen/administration & dosage , Ozone/administration & dosage , Adult , Aged , Aged, 80 and over , COVID-19/therapy , Female , Humans , Male , Middle Aged , Severity of Illness Index , Surveys and Questionnaires
3.
Sci Rep ; 11(1): 17787, 2021 09 07.
Article in English | MEDLINE | ID: covidwho-1397899

ABSTRACT

Despite COVID-19's significant morbidity and mortality, considering cost-effectiveness of pharmacologic treatment strategies for hospitalized patients remains critical to support healthcare resource decisions within budgetary constraints. As such, we calculated the cost-effectiveness of using remdesivir and dexamethasone for moderate to severe COVID-19 respiratory infections using the United States health care system as a representative model. A decision analytic model modelled a base case scenario of a 60-year-old patient admitted to hospital with COVID-19. Patients requiring oxygen were considered moderate severity, and patients with severe COVID-19 required intubation with intensive care. Strategies modelled included giving remdesivir to all patients, remdesivir in only moderate and only severe infections, dexamethasone to all patients, dexamethasone in severe infections, remdesivir in moderate/dexamethasone in severe infections, and best supportive care. Data for the model came from the published literature. The time horizon was 1 year; no discounting was performed due to the short duration. The perspective was of the payer in the United States health care system. Supportive care for moderate/severe COVID-19 cost $11,112.98 with 0.7155 quality adjusted life-year (QALY) obtained. Using dexamethasone for all patients was the most-cost effective with an incremental cost-effectiveness ratio of $980.84/QALY; all remdesivir strategies were more costly and less effective. Probabilistic sensitivity analyses showed dexamethasone for all patients was most cost-effective in 98.3% of scenarios. Dexamethasone for moderate-severe COVID-19 infections was the most cost-effective strategy and would have minimal budget impact. Based on current data, remdesivir is unlikely to be a cost-effective treatment for COVID-19.


Subject(s)
COVID-19/drug therapy , COVID-19/therapy , Health Care Costs/statistics & numerical data , Health Care Rationing/economics , Adenosine Monophosphate/analogs & derivatives , Adenosine Monophosphate/economics , Adenosine Monophosphate/therapeutic use , Alanine/analogs & derivatives , Alanine/economics , Alanine/therapeutic use , COVID-19/diagnosis , COVID-19/economics , COVID-19/mortality , COVID-19/virology , Clinical Decision-Making/methods , Computer Simulation , Cost-Benefit Analysis , Dexamethasone/economics , Dexamethasone/therapeutic use , Health Care Rationing/organization & administration , Humans , Intensive Care Units/economics , Intensive Care Units/statistics & numerical data , Middle Aged , Oxygen/administration & dosage , Oxygen/economics , Quality-Adjusted Life Years , Respiration, Artificial/economics , SARS-CoV-2 , Severity of Illness Index , Treatment Outcome , United States/epidemiology
4.
Pan Afr Med J ; 39: 134, 2021.
Article in English | MEDLINE | ID: covidwho-1359429

ABSTRACT

Introduction: the novel coronavirus disease (COVID-19) pandemic has challenged health systems around the world. This study was designed to describe the socio-demographic characteristics of pregnant women with COVID-19 infection, the common clinical features at presentation and the pregnancy outcome at the University of Benin Teaching Hospital, Edo State, Nigeria. Methods: a cross-sectional analytical study of all confirmed cases of COVID-19 infection from April to September 2020. Results: out of 69 suspected cases that were tested, 19 (28.4%) were confirmed with COVID-19 infection. The common presenting complaints were fever (68.4 %), cough (57.9 %), sore throat (31.6%), malaise (42.1%), loss of taste (26.3%), anosmia (21.1%), and difficulty with breathing (10.6%). In terms of treatment outcome, 57.9% delivered while 36.8% recovered with pregnancy on-going, and 1 (5.3%) maternal death. Of the 11 women who delivered, 45.4% had vaginal deliveries and 54.6 % had Caesarean section. The mean birth weight was 3.1kg and most of the neonates (81.8%) had normal Apgar scores at birth. There was 1 perinatal death from prematurity, birth asphyxia, and intrauterine growth restriction. The commonest diagnosed co-morbidity of pregnancy was preeclampsia and it was significantly associated with severe COVID-19 disease requiring oxygen supplementation (P = 0.028). Conclusion: the clinical symptoms of COVID-19 in pregnancy are similar to those described in the non-pregnant population. It did not seem to worsen the maternal or foetal pregnancy outcome. The occurrence of preeclampsia is significantly associated with severe COVID-19 infection requiring respiratory support.


Subject(s)
COVID-19/complications , Delivery, Obstetric/statistics & numerical data , Pregnancy Complications, Infectious/virology , Pregnancy Outcome , Adult , COVID-19/physiopathology , COVID-19/therapy , Cesarean Section/statistics & numerical data , Cross-Sectional Studies , Female , Hospitals, Teaching , Humans , Infant, Newborn , Maternal Death/statistics & numerical data , Nigeria , Oxygen/administration & dosage , Pre-Eclampsia/epidemiology , Pregnancy , Premature Birth/epidemiology , Retrospective Studies , Severity of Illness Index , Young Adult
5.
Cochrane Database Syst Rev ; 8: CD014962, 2021 08 05.
Article in English | MEDLINE | ID: covidwho-1342863

ABSTRACT

BACKGROUND: Remdesivir is an antiviral medicine with properties to inhibit viral replication of SARS-CoV-2. Positive results from early studies attracted media attention and led to emergency use authorisation of remdesivir in COVID-19.  A thorough understanding of the current evidence regarding the effects of remdesivir as a treatment for SARS-CoV-2 infection based on randomised controlled trials (RCTs) is required. OBJECTIVES: To assess the effects of remdesivir compared to placebo or standard care alone on clinical outcomes in hospitalised patients with SARS-CoV-2 infection, and to maintain the currency of the evidence using a living systematic review approach. SEARCH METHODS: We searched the Cochrane COVID-19 Study Register (which comprises the Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, Embase, ClinicalTrials.gov, WHO International Clinical Trials Registry Platform, and medRxiv) as well as Web of Science (Science Citation Index Expanded and Emerging Sources Citation Index) and WHO COVID-19 Global literature on coronavirus disease to identify completed and ongoing studies without language restrictions. We conducted the searches on 16 April 2021. SELECTION CRITERIA: We followed standard Cochrane methodology. We included RCTs evaluating remdesivir for the treatment of SARS-CoV-2 infection in hospitalised adults compared to placebo or standard care alone irrespective of disease severity, gender, ethnicity, or setting.  We excluded studies that evaluated remdesivir for the treatment of other coronavirus diseases. DATA COLLECTION AND ANALYSIS: We followed standard Cochrane methodology. To assess risk of bias in included studies, we used the Cochrane RoB 2 tool for RCTs. We rated the certainty of evidence using the GRADE approach for outcomes that were reported according to our prioritised categories: all-cause mortality at up to day 28, duration to liberation from invasive mechanical ventilation, duration to liberation from supplemental oxygen, new need for mechanical ventilation (high-flow oxygen or non-invasive or invasive mechanical ventilation), new need for invasive mechanical ventilation, new need for non-invasive mechanical ventilation or high-flow oxygen, new need for oxygen by mask or nasal prongs, quality of life, adverse events (any grade), and serious adverse events. MAIN RESULTS: We included five RCTs with 7452 participants diagnosed with SARS-CoV-2 infection and a mean age of 59 years, of whom 3886 participants were randomised to receive remdesivir. Most participants required low-flow oxygen (n=4409) or mechanical ventilation (n=1025) at baseline. We identified two ongoing studies, one was suspended due to a lack of COVID-19 patients to recruit. Risk of bias was considered to be of some concerns or high risk for clinical status and safety outcomes because participants who had died did not contribute information to these outcomes. Without adjustment, this leads to an uncertain amount of missing values and the potential for bias due to missing data. Effects of remdesivir in hospitalised individuals  Remdesivir probably makes little or no difference to all-cause mortality at up to day 28 (risk ratio (RR) 0.93, 95% confidence interval (CI) 0.81 to 1.06; risk difference (RD) 8 fewer per 1000, 95% CI 21 fewer to 7 more; 4 studies, 7142 participants; moderate-certainty evidence). Considering the initial severity of condition, only one study showed a beneficial effect of remdesivir in patients who received low-flow oxygen at baseline (RR 0.32, 95% CI 0.15 to 0.66, 435 participants), but conflicting results exists from another study, and we were unable to validly assess this observations due to limited availability of comparable data. Remdesivir may have little or no effect on the duration to liberation from invasive mechanical ventilation (2 studies, 1298 participants, data not pooled, low-certainty evidence). We are uncertain whether remdesivir increases or decreases the chance of clinical improvement in terms of duration to liberation from supplemental oxygen at up to day 28 (3 studies, 1691 participants, data not pooled, very low-certainty evidence).   We are very uncertain whether remdesivir decreases or increases the risk of clinical worsening in terms of new need for mechanical ventilation at up to day 28 (high-flow oxygen or non-invasive ventilation or invasive mechanical ventilation) (RR 0.78, 95% CI 0.48 to 1.24; RD 29 fewer per 1000, 95% CI 68 fewer to 32 more; 3 studies, 6696 participants; very low-certainty evidence); new need for non-invasive mechanical ventilation or high-flow oxygen (RR 0.70, 95% CI 0.51 to 0.98; RD 72 fewer per 1000, 95% CI 118 fewer to 5 fewer; 1 study, 573 participants; very low-certainty evidence); and new need for oxygen by mask or nasal prongs (RR 0.81, 95% CI 0.54 to 1.22; RD 84 fewer per 1000, 95% CI 204 fewer to 98 more; 1 study, 138 participants; very low-certainty evidence). The evidence suggests that remdesivir may decrease the risk of clinical worsening in terms of new need for invasive mechanical ventilation (67 fewer participants amongst 1000 participants; RR 0.56, 95% CI 0.41 to 0.77; 2 studies, 1159 participants; low-certainty evidence).  None of the included studies reported quality of life. Remdesivir probably decreases the serious adverse events rate at up to 28 days (RR 0.75, 95% CI 0.63 to 0.90; RD 63 fewer per 1000, 95% CI 94 fewer to 25 fewer; 3 studies, 1674 participants; moderate-certainty evidence). We are very uncertain whether remdesivir increases or decreases adverse events rate (any grade) (RR 1.05, 95% CI 0.86 to 1.27; RD 29 more per 1000, 95% CI 82 fewer to 158 more; 3 studies, 1674 participants; very low-certainty evidence). AUTHORS' CONCLUSIONS: Based on the currently available evidence, we are moderately certain that remdesivir probably has little or no effect on all-cause mortality at up to day 28 in hospitalised adults with SARS-CoV-2 infection. We are uncertain about the effects of remdesivir on clinical improvement and worsening. There were insufficient data available to validly examine the effect of remdesivir on mortality in subgroups depending on the extent of respiratory support at baseline.  Future studies should provide additional data on efficacy and safety of remdesivir for defined core outcomes in COVID-19 research, especially for different population subgroups. This could allow us to draw more reliable conclusions on the potential benefits and harms of remdesivir in future updates of this review. Due to the living approach of this work, we will update the review periodically.


Subject(s)
Adenosine Monophosphate/analogs & derivatives , Alanine/analogs & derivatives , Antiviral Agents/therapeutic use , COVID-19/drug therapy , Adenosine Monophosphate/therapeutic use , Alanine/therapeutic use , Bias , COVID-19/mortality , Cause of Death , Confidence Intervals , Disease Progression , Humans , Middle Aged , Oxygen/administration & dosage , Randomized Controlled Trials as Topic , Respiration, Artificial , SARS-CoV-2 , Ventilator Weaning
6.
Oxid Med Cell Longev ; 2021: 6654388, 2021.
Article in English | MEDLINE | ID: covidwho-1309867

ABSTRACT

Introduction: Risk stratification is an important aspect of COVID-19 management, especially in patients admitted to ICU as it can provide more useful consumption of health resources, as well as prioritize critical care services in situations of overwhelming number of patients. Materials and Methods: A multivariable predictive model for mortality was developed using data solely from a derivation cohort of 160 COVID-19 patients with moderate to severe ARDS admitted to ICU. The regression coefficients from the final multivariate model of the derivation study were used to assign points for the risk model, consisted of all significant variables from the multivariate analysis and age as a known risk factor for COVID-19 patient mortality. The newly developed AIDA score was arrived at by assigning 5 points for serum albumin and 1 point for IL-6, D dimer, and age. The score was further validated on a cohort of 304 patients admitted to ICU due to the severe form of COVID-19. Results: The study population included 160 COVID-19 patients admitted to ICU in the derivation and 304 in the validation cohort. The mean patient age was 66.7 years (range, 20-93 years), with 68.1% men and 31.9% women. Most patients (76.8%) had comorbidities with hypertension (67.7%), diabetes (31.7), and coronary artery disease (19.3) as the most frequent. A total of 316 patients (68.3%) were treated with mechanical ventilation. Ninety-six (60.0%) in the derivation cohort and 221 (72.7%) patients in the validation cohort had a lethal outcome. The population was divided into the following risk categories for mortality based on the risk model score: low risk (score 0-1) and at-risk (score > 1). In addition, patients were considered at high risk with a risk score > 2. By applying the risk model to the validation cohort (n = 304), the positive predictive value was 78.8% (95% CI 75.5% to 81.8%); the negative predictive value was 46.6% (95% CI 37.3% to 56.2%); the sensitivity was 82.4% (95% CI 76.7% to 87.1%), and the specificity was 41.0% (95% CI 30.3% to 52.3%). The C statistic was 0.863 (95% CI 0.805-0.921) and 0.665 (95% CI 0.598-0.732) in the derivation and validation cohorts, respectively, indicating a high discriminative value of the proposed score. Conclusion: In the present study, AIDA score showed a valuable significance in estimating the mortality risk in patients with the severe form of COVID-19 disease at admission to ICU. Further external validation on a larger group of patients is needed to provide more insights into the utility of this score in everyday practice.


Subject(s)
COVID-19 , Hospitalization , Intensive Care Units , Models, Biological , Oxygen , Respiration, Artificial , SARS-CoV-2/metabolism , Adult , Aged , Aged, 80 and over , COVID-19/blood , COVID-19/mortality , COVID-19/therapy , Female , Humans , Male , Middle Aged , Oxygen/administration & dosage , Oxygen/blood , Risk Assessment
7.
Lancet Respir Med ; 9(9): 957-968, 2021 09.
Article in English | MEDLINE | ID: covidwho-1275790

ABSTRACT

BACKGROUND: The major complication of COVID-19 is hypoxaemic respiratory failure from capillary leak and alveolar oedema. Experimental and early clinical data suggest that the tyrosine-kinase inhibitor imatinib reverses pulmonary capillary leak. METHODS: This randomised, double-blind, placebo-controlled, clinical trial was done at 13 academic and non-academic teaching hospitals in the Netherlands. Hospitalised patients (aged ≥18 years) with COVID-19, as confirmed by an RT-PCR test for SARS-CoV-2, requiring supplemental oxygen to maintain a peripheral oxygen saturation of greater than 94% were eligible. Patients were excluded if they had severe pre-existing pulmonary disease, had pre-existing heart failure, had undergone active treatment of a haematological or non-haematological malignancy in the previous 12 months, had cytopenia, or were receiving concomitant treatment with medication known to strongly interact with imatinib. Patients were randomly assigned (1:1) to receive either oral imatinib, given as a loading dose of 800 mg on day 0 followed by 400 mg daily on days 1-9, or placebo. Randomisation was done with a computer-based clinical data management platform with variable block sizes (containing two, four, or six patients), stratified by study site. The primary outcome was time to discontinuation of mechanical ventilation and supplemental oxygen for more than 48 consecutive hours, while being alive during a 28-day period. Secondary outcomes included safety, mortality at 28 days, and the need for invasive mechanical ventilation. All efficacy and safety analyses were done in all randomised patients who had received at least one dose of study medication (modified intention-to-treat population). This study is registered with the EU Clinical Trials Register (EudraCT 2020-001236-10). FINDINGS: Between March 31, 2020, and Jan 4, 2021, 805 patients were screened, of whom 400 were eligible and randomly assigned to the imatinib group (n=204) or the placebo group (n=196). A total of 385 (96%) patients (median age 64 years [IQR 56-73]) received at least one dose of study medication and were included in the modified intention-to-treat population. Time to discontinuation of ventilation and supplemental oxygen for more than 48 h was not significantly different between the two groups (unadjusted hazard ratio [HR] 0·95 [95% CI 0·76-1·20]). At day 28, 15 (8%) of 197 patients had died in the imatinib group compared with 27 (14%) of 188 patients in the placebo group (unadjusted HR 0·51 [0·27-0·95]). After adjusting for baseline imbalances between the two groups (sex, obesity, diabetes, and cardiovascular disease) the HR for mortality was 0·52 (95% CI 0·26-1·05). The HR for mechanical ventilation in the imatinib group compared with the placebo group was 1·07 (0·63-1·80; p=0·81). The median duration of invasive mechanical ventilation was 7 days (IQR 3-13) in the imatinib group compared with 12 days (6-20) in the placebo group (p=0·0080). 91 (46%) of 197 patients in the imatinib group and 82 (44%) of 188 patients in the placebo group had at least one grade 3 or higher adverse event. The safety evaluation revealed no imatinib-associated adverse events. INTERPRETATION: The study failed to meet its primary outcome, as imatinib did not reduce the time to discontinuation of ventilation and supplemental oxygen for more than 48 consecutive hours in patients with COVID-19 requiring supplemental oxygen. The observed effects on survival (although attenuated after adjustment for baseline imbalances) and duration of mechanical ventilation suggest that imatinib might confer clinical benefit in hospitalised patients with COVID-19, but further studies are required to validate these findings. FUNDING: Amsterdam Medical Center Foundation, Nederlandse Organisatie voor Wetenschappelijk Onderzoek/ZonMW, and the European Union Innovative Medicines Initiative 2.


Subject(s)
COVID-19/therapy , Imatinib Mesylate/administration & dosage , Protein Kinase Inhibitors/administration & dosage , Respiration, Artificial/statistics & numerical data , Respiratory Insufficiency/therapy , Aged , COVID-19/complications , COVID-19/diagnosis , COVID-19/virology , Capillary Permeability/drug effects , Combined Modality Therapy/adverse effects , Combined Modality Therapy/methods , Double-Blind Method , Female , Humans , Imatinib Mesylate/adverse effects , Male , Middle Aged , Netherlands , Oxygen/administration & dosage , Placebos/administration & dosage , Placebos/adverse effects , Protein Kinase Inhibitors/adverse effects , Respiratory Insufficiency/diagnosis , Respiratory Insufficiency/virology , SARS-CoV-2/isolation & purification , Severity of Illness Index , Time Factors , Treatment Outcome
8.
Medicine (Baltimore) ; 100(21): e26059, 2021 May 28.
Article in English | MEDLINE | ID: covidwho-1242122

ABSTRACT

BACKGROUND: : Coronavirus disease 2019 (COVID-19) is an emerging and rapidly evolving disease, with no recommended effective anti-coronavirus treatments. Traditional Chinese Medicine (TCM) has been widely used to treat COVID-19 in China, and the most used one is Lianhuaqingwen (LH). This study aimed to assess the efficacy and safety of LH combined with usual treatment vs usual treatment alone in treating mild or moderate COVID-19 by a meta-analysis of randomized controlled trials (RCTs). METHODS AND ANALYSIS: : We systematically searched the Medline (OVID), Embase, the Cochrane Library, and 4 Chinese databases from inception to July 2020 to include the RCTs that evaluated the efficacy and safety of LH in combination with usual treatment vs usual treatment for mild or moderate COVID-19. A meta-analysis was performed to calculate the risk ratio (RR) and 95% confidence interval (CI) for binary outcomes and mean difference (MD) for continuous outcomes. RESULTS: : A total of 5 RCTs with 824 individuals with mild or moderate COVID 19 were included. Compared with the usual treatment alone, LH in combination with usual treatment significantly improved the overall clinical efficacy (RR = 2.39, 95% CI 1.61-3.55), increased the rate of recovery of chest computed tomographic manifestations (RR = 1.80, 95% CI 1.08-3.01), reduced the rate of conversion to severe cases (RR = 0.47, 95% CI 0.29-0.74), shorten the duration of fever (MD = -1.00, 95% CI -1.17 to -0.84). Moreover, LH in combination with usual treatment did not increase the occurrence of the adverse event compared to usual treatment alone. CONCLUSION: : Our meta-analysis of RCTs indicated that LH in combination with usual treatment may improve the clinical efficacy in patients with mild or moderate COVID-19 without increasing adverse events. However, given the limitations and poor quality of included trials in this study, further large-sample RCTs or high-quality real-world studies are needed to confirm our conclusions.


Subject(s)
Antiviral Agents/administration & dosage , COVID-19/therapy , Drugs, Chinese Herbal/administration & dosage , Oxygen/administration & dosage , Antiviral Agents/adverse effects , COVID-19/diagnosis , COVID-19/virology , China , Combined Modality Therapy/adverse effects , Combined Modality Therapy/methods , Drugs, Chinese Herbal/adverse effects , Humans , Lung/diagnostic imaging , Nutritional Support , Oxygen/adverse effects , Randomized Controlled Trials as Topic , SARS-CoV-2/isolation & purification , Severity of Illness Index , Tomography, X-Ray Computed , Treatment Outcome
9.
Medicine (Baltimore) ; 100(21): e26023, 2021 May 28.
Article in English | MEDLINE | ID: covidwho-1242120

ABSTRACT

ABSTRACT: To assess tocilizumab (TCZ) efficacy associated to standard of care (SOC) compared to SOC alone in severe coronavirus associated disease 2019 (COVID-19) patients. In a matched case-control study from 3 French Hospital COVID-19 Departments, 27 patients with severe COVID-19 treated with TCZ and SOC were matched for baseline epidemiological and clinical features and compared to 27 severe COVID-19 patients treated with SOC alone. Baseline characteristics of the study population were comparable between groups. Eleven patients (20%) died. TCZ was not associated with clinical improvement as compared to SOC regarding oxygen-free status (44% vs 63%) and death (18.5% vs 22%), despite a higher decrease of the C-reactive protein at Day 7 (10.7 vs 52 mg/L; P < 10-3). Compared to the 43 patients alive at the end-of follow-up, patients who died were older (78 vs 64 years; P < 10-3), with 82% of them older than 72 years vs only 23% of live patients (P < 10-3). Age (OR = 1.15; 95%CI = 1.04-1.3; P = .008) and age over 72 years (OR) = 14.85; 95%CI = 2.7-80; P = .002) were independently associated with mortality. TCZ in addition to SOC for severe COVID-19 patients did not reduce mortality, subsequent need for invasive mechanical ventilation nor did it shorten the time of oxygen support, despite better control of the inflammatory response. More powerful and randomized controlled trials are warranted to determine if TCZ is effective in the management of COVID-19.


Subject(s)
Antibodies, Monoclonal, Humanized/therapeutic use , COVID-19/drug therapy , COVID-19/therapy , Respiration, Artificial/statistics & numerical data , Standard of Care/statistics & numerical data , Age Factors , Aged , COVID-19/diagnosis , COVID-19/mortality , COVID-19/virology , Case-Control Studies , Female , Follow-Up Studies , France/epidemiology , Hospital Mortality , Humans , Male , Middle Aged , Oxygen/administration & dosage , Retrospective Studies , Risk Factors , SARS-CoV-2/isolation & purification , Severity of Illness Index , Treatment Outcome
11.
Med Hypotheses ; 146: 110421, 2021 Jan.
Article in English | MEDLINE | ID: covidwho-1233540

ABSTRACT

BACKGROUND: Infection with SARS-CoV-2 is responsible for the COVID-19 crisis affecting the whole world. This virus can provoke acute respiratory distress syndrome (ARDS) leading to overcrowed the intensive care unit (ICU). Over the last months, worldwide experience demonstrated that the ARDS in COVID-19 patients are in many ways "atypical". The mortality rate in ventilated patients is high despite the application of the gold standard treatment (protective ventilation, curare, prone position, inhaled NO). Several studies suggested that the SARS-CoV-2 could interact negatively on red blood cell homeostasis. Furthermore, SarsCov2 creates Reactive Oxygen Species (ROS), which are toxic and generate endothelial dysfunction. Hypothesis/objective(s) We hypothesis that HEMO2Life® administrated intravenously is safe and could help symptomatically the patient condition. It would increase arterial oxygen content despite lung failure and allow better tissue oxygenation control. The use of HEMO2Life® is also interesting due to its anti-oxidative effect preventing cytokine storm induced by the SARS-CoV-2. Evaluation of the hypothesis: Hemarina is based on the properties of the hemoglobin of the Arenicola marina sea-worm (HEMO2Life®). This extracellular hemoglobin has an oxygen capacity 40 times greater than the hemoglobin of vertebrates. Furthermore, the size of this molecule is 250 times smaller than a human red blood cell, allowing it to diffuse in all areas of the microcirculation, without diffusing outside the vascular sector. It possesses an antioxidative property du a Superoxide Dismutase Activity. This technology has been the subject of numerous publications and HEMO2Life® was found to be well-tolerated and did not induce toxicity. It was administered intravenously to hamsters and rats, and showed no acute effect on heart rate and blood pressure and did not cause microvascular vasoconstriction. In preclinical in vivo models (mice, rats, and dogs), HEMO2Life® has enabled better tissue oxygenation, especially in the brain. This molecule has already been used in humans in organ preservation solutions and the patients showed no abnormal clinical signs. CONSEQUENCES OF THE HYPOTHESIS: The expected benefits of HEMO2Life® for COVID-19 patients are improved survival, avoidance of tracheal intubation, shorter oxygen supplementation, and the possibility of treating a larger number of patients as molecular respirator without to use an invasive machine.


Subject(s)
COVID-19/complications , COVID-19/therapy , Hemoglobins/therapeutic use , Hypoxia/etiology , Hypoxia/therapy , Models, Biological , Oxygen/administration & dosage , Animals , COVID-19/physiopathology , Cricetinae , Dogs , Hemoglobins/administration & dosage , Hemoglobins/metabolism , Humans , Hypoxia/physiopathology , Injections, Intravenous , Mice , Oxidative Stress/drug effects , Oxygen/metabolism , Pandemics , Rats , SARS-CoV-2 , Translational Medical Research
12.
Adv Sci (Weinh) ; 8(18): 2100316, 2021 09.
Article in English | MEDLINE | ID: covidwho-1233162

ABSTRACT

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has led to an unprecedented global health crisis, resulting in a critical need for effective vaccines that generate protective antibodies. Protein subunit vaccines represent a promising approach but often lack the immunogenicity required for strong immune stimulation. To overcome this challenge, it is first demonstrated that advanced biomaterials can be leveraged to boost the effectiveness of SARS-CoV-2 protein subunit vaccines. Additionally, it is reported that oxygen is a powerful immunological co-adjuvant and has an ability to further potentiate vaccine potency. In preclinical studies, mice immunized with an oxygen-generating coronavirus disease 2019 (COVID-19) cryogel-based vaccine (O2-CryogelVAX) exhibit a robust Th1 and Th2 immune response, leading to a sustained production of highly effective neutralizing antibodies against the virus. Even with a single immunization, O2-CryogelVAX achieves high antibody titers within 21 days, and both binding and neutralizing antibody levels are further increased after a second dose. Engineering a potent vaccine system that generates sufficient neutralizing antibodies after one dose is a preferred strategy amid vaccine shortage. The data suggest that this platform is a promising technology to reinforce vaccine-driven immunostimulation and is applicable to current and emerging infectious diseases.


Subject(s)
COVID-19 Vaccines/administration & dosage , COVID-19/immunology , COVID-19/prevention & control , Cryogels/administration & dosage , Drug Delivery Systems/methods , Oxygen/administration & dosage , Oxygen/immunology , Animals , Biocompatible Materials , Female , Immunity/immunology , Mice , Models, Animal , SARS-CoV-2
14.
J Trauma Acute Care Surg ; 89(6): 1092-1098, 2020 12.
Article in English | MEDLINE | ID: covidwho-1214720

ABSTRACT

BACKGROUND: Invasive mechanical ventilation (IMV) is a lifesaving strategy for critically ill patients with coronavirus disease 2019 (COVID-19). We aim to report the case series of critical patients receiving IMV in Wuhan and to discuss the timing of IMV in these patients. METHODS: Data of 657 patients admitted to emergency intensive care unit of Zhongnan Hospital and isolated isolation wards of Wuhan Union Hospital from January 1 to March 10, 2020, were retrospectively reviewed. All medical records of 40 COVID-19 patients who required IMV were collected at different time points, including baseline (at admission), before receiving IMV, and before death or hospital discharge. RESULTS: Among 40 COVID-19 patients with IMV, 31 died, and 9 survived and was discharged. The median age was 70 years (interquartile range [IQR], 62-76 years), and nonsurvivors were older than survivors. The median period from the noninvasive mechanic ventilation (NIV) or high-flow nasal cannula oxygen therapy (HFNC) to intubation was 7 hours (IQR, 2-42 hours) in IMV survivors and 54 hours (IQR, 28-143 hours) in IMV nonsurvivors. We observed that, when the time interval from NIV/HFNC to intubation was less than 50 hours (about 2 calendar days), together with Acute Physiology and Chronic Health Evaluation II (APACHE II) score of less than 10 or pneumonia severity index (PSI) score of less than 100, mortality can be reduced to 60% or less. Prolonged interval from NIV/HFNC to intubation and high levels of APACHE II and PSI before intubation were associated with higher mortality in critically ill patients. Multiple organ damage was common among these nonsurvivors in the course of treatment. CONCLUSION: Early initial intubation after NIV/HFNC might have a beneficial effect in reducing mortality for critically ill patients meeting IMV indication. Considering APACHE II and PSI scores might help physicians in decision making about timing of intubation for curbing subsequent mortality. LEVEL OF EVIDENCE: Therapeutic, level V.


Subject(s)
Coronavirus Infections/therapy , Critical Illness/therapy , Hospital Mortality , Noninvasive Ventilation/methods , Oxygen/administration & dosage , Pneumonia, Viral/therapy , APACHE , Aged , Betacoronavirus , COVID-19 , China , Coronavirus Infections/mortality , Critical Illness/mortality , Female , Hospitalization , Humans , Intensive Care Units , Male , Middle Aged , Oxygen Inhalation Therapy/methods , Pandemics , Pneumonia, Viral/mortality , Retrospective Studies , SARS-CoV-2 , Time Factors
15.
J Med Virol ; 93(3): 1817-1823, 2021 03.
Article in English | MEDLINE | ID: covidwho-1196512

ABSTRACT

Corticosteroids reduce mortality in hospitalized patients with coronavirus disease 2019 (COVID-19), but the response seems to vary according to the level of respiratory support needed. This retrospective cohort study included COVID-19 patients with oxygen saturation (SatO2 ) in room air <92% admitted between March 3 and April 30, 2020. Following the interim protocol, patients could receive dexamethasone or methylprednisolone, and were classified according to oxygen requirements. The primary endpoint was admission to the intensive care unit (ICU) or mortality. Kaplan-Meier and Cox hazards analyses were used. Of the 115 patients included, 38 received corticosteroids. Among requiring high-flow, noninvasive ventilation (NIV) or fraction of inspired oxygen (FiO2 ) > 0.40, the hazard ratio (HR) for death or ICU admission, between the corticosteroids and non-corticosteroids group, was 0.07 (95% CI 0.01-0.4), p = .002, and for patients requiring low-flow oxygen, the HR was 0.70 (95% CI 0.13-3.8), p = .68. Significant differences were also observed when all patients were analyzed together. A significant reduction in mortality and ICU admission frequency was observed among patients requiring high-flow oxygen or NIV, but not among those requiring low-flow oxygen. Better targeting of COVID-19 patients is needed for the beneficial use of corticosteroids.


Subject(s)
Adrenal Cortex Hormones/therapeutic use , COVID-19/drug therapy , COVID-19/mortality , Oxygen/administration & dosage , Aged , Aged, 80 and over , COVID-19/virology , Dexamethasone/therapeutic use , Female , Hospital Mortality , Hospitalization , Humans , Intensive Care Units , Male , Methylprednisolone/therapeutic use , Middle Aged , Respiration, Artificial/methods , Retrospective Studies , SARS-CoV-2/drug effects , Spain
16.
J Med Virol ; 93(3): 1532-1537, 2021 03.
Article in English | MEDLINE | ID: covidwho-1196470

ABSTRACT

COVID-19 pandemic has been affecting the whole world by increasing morbidity and mortality rates day by day. Treatment algorithms have been attempted as parallel to the increasing experience with COVID-19. In the pathogenesis of this virus pro-inflammatory cytokine storm has been called to have the main role. The right timing should be made for treatments. We proposed IL- 1 blocking by anakinra in seventeen COVID-19 patients at high risk of worsening. Patients were assessed according to HScore, SOFA (Sequential Organ Failure Assessment Score = SOFA), MuLBSTA Score (multilobular infiltration, hypo-lymphocytosis, bacterial coinfection, smoking history, hyper-tension, and age), Brescia-COVID respiratory severity scale (BCRSS). In our study, the mortality rate was 17.6%. Consequently, 1 (5.9%) patient was receiving low-flow oxygen supply, 3 (17.6%) patients needed no longer oxygen supply and 10 (58.8%) patients were discharged from the hospital. According to the results of our study in the manner of general evaluation; we found that SOFA, MuLBSTA, and BCRSS scores were one step ahead according to HScore being insufficient to determine early phases of the disease. In our opinion, the prominent factors that emphasize the use of anakinra could be listed as comorbidity, risk, or presence of secondary infection, ongoing malignant disease. However, the other factors that enhance the use of anakinra in the situation of viremia also could be sorted as no response to full dose antivirals, antiviral side effects, or no success to antiviral treatment.


Subject(s)
Antiviral Agents/therapeutic use , COVID-19/drug therapy , Interleukin 1 Receptor Antagonist Protein/therapeutic use , Pneumonia/drug therapy , COVID-19/virology , Comorbidity , Female , Humans , Male , Middle Aged , Oxygen/administration & dosage , Pandemics/prevention & control , Severity of Illness Index
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