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1.
Blood Purif ; : 1-9, 2022 May 17.
Article in English | MEDLINE | ID: covidwho-1846591

ABSTRACT

INTRODUCTION: Uncontrolled overproduction of inflammatory mediators is predominantly observed in patients with severe COVID-19. The excessive immune response gives rise to multiple organ dysfunction. Implementing extracorporeal therapies may be useful in omitting inflammatory mediators and supporting different organ systems. We aimed to investigate the effectiveness of hemoperfusion in combination with standard therapy in critically ill COVID-19 patients. METHOD: We conducted a single-center, matched control retrospective study on patients with confirmed SARS-CoV-2 infection. Patients were treated with hemoperfusion in combination with standard therapy (hemoperfusion group) or standard treatment (matched group). Hemoperfusion or hemoperfusion and continuous renal replacement therapies were initiated in the hemoperfusion group. The patients in the matched group were matched one by one with the hemoperfusion group for age, sex, oxygen saturation (SPO2) at the admission, and the frequency of using invasive mechanical ventilation during hospitalization. Two types of hemoperfusion cartridges used in this study were Jafron© (HA330) and CytoSorb® 300. RESULT: A total of 128 COVID-19-confirmed patients were enrolled in this study; 73 patients were allotted to the matched group and 55 patients received hemoperfusion. The median SPO2 at the admission day in the control and hemoperfusion groups was 80% and 75%, respectively (p value = 0.113). The mortality rate was significantly lower in the hemoperfusion group compared to the matched group (67.3% vs. 89%; p value = 0.002). The median length of ICU stay was statistically different in studied groups (median, 12 days for hemoperfusion group vs. 8 days for the matched group; p < 0.001). The median final SPO2 was statistically higher in the hemoperfusion group than in the matched group, and the median PaCO2 was lower. CONCLUSION: Among critically ill COVID-19 patients, based on our study, the use of hemoperfusion may reduce the mortality rate and improve SPO2 and PaCO2.

2.
EuropePMC; 2021.
Preprint in English | EuropePMC | ID: ppcovidwho-309089

ABSTRACT

Introduction: In critically ill COVID-19 patients, uncontrolled over-production of inflammatory mediators is observed, dominantly. The excessive immune response give rise to multiple organ dysfunction. Implementing extracorporeal therapies may be useful in omitting inflammatory mediators and supporting different organ systems. We aimed to investigate the effectiveness of hemoperfusion in combination with standard therapy in critically ill COVID-19 patients. Method: We conducted a single-center, matched control retrospective study on patients with confirmed SARS-CoV-2 infection. Patients were treated with hemoperfusion in combination with standard therapy (hemoperfusion group) or standard treatment (matched group). Hemoperfusion or hemoperfusion and CRRT (continuous renal replacement therapy) therapies were initiated in hemoperfusion group. The patients in the matched group were matched one by one with the hemoperfusion group for age, sex, the oxygen saturation (SPO2) at the admission and the frequency of using invasive mechanical ventilation during hospitalization. Two types of hemoperfusion cartridges used in this study were Jafron© (HA330) or cytosorb® 300. Result: A total number of 128 COVID- 19 confirmed patients were enrolled in this study;73 patients were allotted to the matched group and 55 patients received hemoperfusion. The median SPO2 at the admission in control and hemoperfusion groups was 80% and 75%, respectively (P-value=0.113). The mortality rate was significantly lower in hemoperfusion group compared to the matched group (67.3% vs. 89%;P.value=0.002). The median length of ICU stay was statistically different in studied groups (median, 12 days for hemoperfusion group vs. 8 days for the matched group;P<0.001). The median of final oxygen saturation was statistically higher and median of PaCO2 was lower in hemoperfusion group compared to the matched group. Conclusion: Among critically ill COVID-19 patients, the use of hemoperfusion reduces the mortality rate and improves oxygen saturation and PaCO2.

3.
EuropePMC; 2021.
Preprint in English | EuropePMC | ID: ppcovidwho-309088

ABSTRACT

Introduction: Coronavirus disease 2019 (COVID-19) has been a serious obstacle in front of public health. Interferon-beta 1a (IFN-β 1a) has been used to treat patients with COVID-19. We aimed to compare the effectiveness of high-dose IFN-β 1a compared to low dose IFN-β 1a in moderate to severe COVID-19 cases. Methods: In this randomized, controlled, and clinical trial, eligible patients with confirmed SARS-CoV-2 infections were randomly assigned to receive one of the two following therapeutic regimens: The intervention group was treated with high-dose IFN-β 1a (Recigen) (Subcutaneous injections of 88μg (24,000 IU) on days 1, 3, 6) + lopinavir /ritonavir (Kaletra) and the control group was treated with low-dose IFN-β 1a (Recigen) (Subcutaneous injections of 44μg (12,000 IU) on days 1, 3, 6) + lopinavir /ritonavir (Kaletra) (400mg/100 mg twice a day for 10 days, orally, in two groups). Result: A total of 168 COVID- 19 confirmed patients underwent randomization;83 were assigned to the intervention group and 85 were assigned to the control group. Median Time To Clinical Improvement (TTIC) for cases treated with low-dose IFN-β1a was shorter than that for cases treated with high-dose IFN-β1a (6 vs10 days). Due to differences between some baseline clinical factors between intervention and control group, we performed an adjusted analysis. The model failed to reach a significant difference between two groups. Conclusion: The use of high-dose IFN-β 1a did not improve TTCI in hospitalized patients with moderate to severe COVID-19. Also, it did not have any significant effect on mortality reduction compared with treating with low-dose IFN-β 1a. Trial registration: The trial was confirmed by the Ethics in Medical Research Committee of the Shahid Beheshti University of Medical Sciences. Signed informed consents were obtained from all the participants or their legally authorized representatives. This trial has been registered as ClinicalTrials.gov, NCT04521400.

4.
EuropePMC; 2021.
Preprint in English | EuropePMC | ID: ppcovidwho-304915

ABSTRACT

Purpose: Considering the anti-inflammatory effect of atorvastatin and the role of medical comorbidities such as hypertension and coronary artery disease on prognosis of the COVID-19 patients, we aimed to assess the effect of atorvastatin add-on therapy on mortality due to COVID-19. Methods: We conducted a retrospective cohort study, including patients who were hospitalized with confirmed diagnosis of severe COVID-19. Baseline characteristics and related clinical data of patients were recorded. Clinical outcomes consist of in hospital mortality, need for invasive mechanical ventilation and hospital length of stay. COX regression analysis models were used to assess the association of independent factors to outcomes. Results: Atorvastatin was administered for 421 out of 991 patients. The mean age was 61.640±17.003 years. Older age, higher prevalence of hypertension and coronary artery disease reported in patients who received atorvastatin. These patients had shorter hospital length of stay (P=0.001). Based on COX proportional hazard model, in hospital use of atorvastatin was associated to decrease in mortality (HR=0.679, P=0.005) and lower need for invasive mechanical ventilation (HR=0.602, P=0.014). Conclusions: Atorvastatin add-on therapy in patient with severe COVID-19 was associated with lower in hospital mortality and reduced the risk of need for invasive mechanical ventilation which support to continue the prescription of the medication.

5.
EuropePMC; 2021.
Preprint in English | EuropePMC | ID: ppcovidwho-320597

ABSTRACT

Background: More than one year of emerging COVID 19 infection, no signs of the pandemic remission appear. Returning of symptomatic patients who had a history of recovered COVID-19 disease with a new positive SARS Cov-2 PCR test after several weeks to months of a negative PCR result is one of the novels challenging phenomena during the pandemic. In this study, we determined the clinical and laboratory characteristics of these Iranian patients and discussed possible reasons. METHOD We retrospectively investigated the SARS Cov-2 PCR tests performed in the three referral hospitals six months after the pandemic onset. All patients who had the following criteria were included in the study: two SARS COV2 PCR positive tests three months apart, have no symptoms, and a negative PCR between the two positive tests, access to the patient and his medical information. Then, retrospectively recorded the clinical and laboratory characteristics of the eligible patients. We also compare clinical and laboratory features of the second episode to the first. RESULT A total of 32,567 tests were performed, of which 1899 patients. Finally, 37 cases were eligible in the study based on our criteria. The majority of patients were male and nurses. The mean body mass index was 25.84±3.25. The mean age was 37.54 ±15.16 years old. Weakness, myalgia, and fever were the most clinical presentation symptoms in both episodes. Chest Computed Tomography (CT) scan showed pneumonia in 56.8% and 43.2% of cases in the first and second episodes, respectively. The mean duration between the discharge and second presentation was 117±61.42 days. Seven (18.9%) patients hospitalized in the second episode compared to 2 (5.4%) cases in the first. The clinical, radiological, and laboratory characteristics were not significantly different between the two episodes except for significantly more dexamethasone usage in the second one (p= 0.03). CONCLSION Although we could not perform the phylogenic sequencing of SARS-CoV-2 and viral culture in the re-presenting symptomatic patients with positive RT-PCR, prolonged duration between two episodes suggest probably reinfection in our cases. Finally, this clinical phenomenon may be more common in healthcare providers without a significant consequence.

6.
J Clin Lab Anal ; 36(2): e24226, 2022 Feb.
Article in English | MEDLINE | ID: covidwho-1611241

ABSTRACT

INTRODUCTION: RT-PCR is widely used as a diagnostic test for the detection of SARS-CoV-2. In this study, we aim to describe the clinical utility of serial PCR testing in the final detection of COVID-19. METHOD: We collected multiple nasopharyngeal swab samples from patients who had negative RT-PCR test on the first day after hospitalization. RT-PCR tests were performed on the second day for all patients with initial negative result. For the patients with secondary negative results on day 2, tertiary RT-PCR tests were performed on day 3 after hospitalization. RESULT: Among 68 patients with initial negative test results, at the end of follow-up, the mortality number was 20 (29.4%). About 33.8% of patients had subsequent positive PCR test results for the second time and 17.4% of the patients who performed third PCR test had positive result. CONCLUSION: Based on this study, serial RT-PCR testing is unlikely to yield additional information.


Subject(s)
COVID-19/diagnosis , Molecular Diagnostic Techniques , Real-Time Polymerase Chain Reaction , SARS-CoV-2/genetics , Aged , Aged, 80 and over , False Negative Reactions , Female , Humans , Male , Middle Aged , Molecular Diagnostic Techniques/methods , Molecular Diagnostic Techniques/standards , Molecular Diagnostic Techniques/statistics & numerical data , Real-Time Polymerase Chain Reaction/methods , Real-Time Polymerase Chain Reaction/standards , Real-Time Polymerase Chain Reaction/statistics & numerical data , SARS-CoV-2/isolation & purification
7.
Int Immunopharmacol ; 99: 107969, 2021 Oct.
Article in English | MEDLINE | ID: covidwho-1307010

ABSTRACT

INTRODUCTION: The effectiveness of umifenovir against COVID-19 is controversial; therefore, clinical trials are crucial to evaluate its efficacy. METHODS: The study was conducted as a single-center, randomized, open-label clinical trial. Eligible moderate-severe hospitalized patients with confirmed SARS-Cov-2 infection were randomly segregated into intervention and control groups. The intervention group were treated with lopinavir/ritonavir (400 mg/100 mg bid for 10-14 days) + hydroxychloroquine (400 mg single dose) + interferon-ß1a (Subcutaneous injections of 44 µg (12,000 IU) on days 1, 3, 5) + umifenovir (200 mg trice daily for 10 days), and the control group received lopinavir/ritonavir (same dose) + hydroxychloroquine (same dose) + interferon-ß1a (same dose). RESULTS: Of 1180 patients with positive RT-PCRs and positive chest CT scans, 101 patients were finally included in the trial; 50 were assigned to receive IFNß1a + hydroxychloroquine + lopinavir/ritonavir group and 51 were managed to treat with IFNß1a + hydroxychloroquine + lopinavir/ritonavir + umifenovir. Since all patients received the intended treatment as scheduled, the analysis just included as the ITT population. Time to clinical improvement (TTCI) did not hold a statistically significant difference between intervention and control groups (median, 9 days for intervention group versus 7 days for the control group; P: 0.22). Besides, Hazard Ratio for TTCI in the Cox regression model was 0.75 (95% CI: 0.45-1.23, P:0.25) which also confirmed that there was no statistically significant difference between the treatment group and the control group. The mortality was not statistically significant between the two groups (38% in controls vs 33.3% treatment group). CONCLUSIONS: Our findings shed new lights on the facts that additional umifenovir has not been found to be effective in shortening the duration of SARS-CoV-2 in severe patients and improving the prognosis in non-ICU patients and mortality. TRIAL REGISTRATION: The trial was confirmed by the Ethics in Medical Research Committee of the Shahid Beheshti University of Medical Sciences. signed informed consents were obtained from all the participants or their legally authorized representatives. This trial has been registered as ClinicalTrials.gov, NCT04350684.


Subject(s)
Antiviral Agents/therapeutic use , COVID-19/drug therapy , Indoles/therapeutic use , Adult , Aged , Drug Therapy, Combination , Female , Humans , Hydroxychloroquine , Interferon beta-1a/therapeutic use , Lopinavir/therapeutic use , Male , Middle Aged , Ritonavir/therapeutic use
8.
Int J Clin Pract ; 75(9): e14434, 2021 Sep.
Article in English | MEDLINE | ID: covidwho-1255410

ABSTRACT

PURPOSE: Considering the anti-inflammatory effect of atorvastatin and the role of medical comorbidities such as hypertension and coronary artery disease on the prognosis of the COVID-19 patients, we aimed to assess the effect of atorvastatin add-on therapy on mortality caused by COVID-19. METHODS: We conducted a retrospective cohort study, including patients who were hospitalised with confirmed diagnosis of severe COVID-19. Baseline characteristics and related clinical data of patients were recorded. Clinical outcomes consist of in-hospital mortality, need for invasive mechanical ventilation and hospital length of stay. COX regression analysis models were used to assess the association of independent factors to outcomes. RESULTS: Atorvastatin was administered for 421 of 991 patients. The mean age was 61.640 ± 17.003 years. Older age, higher prevalence of hypertension and coronary artery disease reported in patients who received atorvastatin. These patients have shorter hospital length of stay (P = .001). Based on COX proportional hazard model, in-hospital use of atorvastatin was associated with decrease in mortality (HR = 0.679, P = .005) and lower need for invasive mechanical ventilation (HR = 0.602, P = .014). CONCLUSIONS: Atorvastatin add-on therapy in patient with severe COVID-19 was associated with lower in-hospital mortality and reduced the risk of need for invasive mechanical ventilation which supports to continue the prescription of the medication.


Subject(s)
COVID-19 , Respiration, Artificial , Adult , Aged , Atorvastatin/therapeutic use , Hospital Mortality , Humans , Middle Aged , Retrospective Studies , SARS-CoV-2
9.
Arch Iran Med ; 24(2): 144-151, 2021 Feb 01.
Article in English | MEDLINE | ID: covidwho-1106763

ABSTRACT

BACKGROUND: The scientific evidence concerning pathogenesis and immunopathology of the coronavirus disease 2019 (COVID-19) is rapidly evolving in the literature. To evaluate the different tissues obtained by biopsy and autopsy from five patients who expired from severe COVID-19 in our medical center. METHODS: This retrospective study reviewed five patients with severe COVID-19, confirmed by reverse transcription-polymerase chain reaction (RT-PCR) and imaging, to determine the potential correlations between histologic findings with patient outcome. RESULTS: Diffuse alveolar damage (DAD) and micro-thrombosis were the most common histologic finding in the lung tissues (4 of 5 cases), and immunohistochemical (IHC) findings (3 of 4 cases) suggested perivascular aggregation and diffuse infiltration of alveolar walls by CD4+ and CD8+ T lymphocytes. Two of five cases had mild predominantly perivascular lymphocytic infiltration, single cell myocardial necrosis and variable interstitial edema in myocardial samples. Hypertrophic cardiac myocytes, representing hypertensive cardiomyopathy was seen in one patient and CD4+ and CD8+ T lymphocytes were detected on IHC in two cases. In renal samples, acute tubular necrosis was observed in 3 of 5 cases, while chronic tubulointerstitial nephritis, crescent formation and small vessel fibrin thrombi were observed in 1 of 5 samples. Sinusoidal dilation, mild to moderate chronic portal inflammation and mild mixed macro- and micro-vesicular steatosis were detected in all liver samples. CONCLUSION: Our observations suggest that clinical pathology findings on autopsy tissue samples could shed more light on the pathogenesis, and consequently the management, of patients with severe COVID-19.


Subject(s)
COVID-19/pathology , Critical Illness , Kidney/pathology , Liver/pathology , Lung/pathology , Myocardium/pathology , Aged , COVID-19/epidemiology , Fatal Outcome , Female , Humans , Male , Middle Aged , Pandemics , Retrospective Studies
10.
Trials ; 21(1): 880, 2020 Oct 26.
Article in English | MEDLINE | ID: covidwho-892370

ABSTRACT

OBJECTIVES: We will investigate the effectiveness of high dose Interferon Beta 1a, compared to low dose Interferon Beta 1a (the base therapeutic regimen) in COVID-19 Confirmed Cases (Either RT-PCR or CT Scan Confirmed) with moderate to severe disease TRIAL DESIGN: This is a single center, open label, randomized, controlled, 2-arm parallel group (1:1 ratio), clinical trial. PARTICIPANTS: The eligibility criteria in this study is: age ≥ 18 years, oxygen saturation (SPO2) ≤ 93% or respiratory rate ≥ 24, at least one of the following manifestation: radiation contactless body temperature ≥37.8, Cough, shortness of breath, nasal congestion/ discharge, myalgia/arthralgia, diarrhea/vomiting, headache or fatigue on admission. The onset of the symptoms should be acute (≤ 14 days). The exclusion criteria include refusal to participate, using drugs with potential interaction with lopinavir/ritonavir or interferon-ß 1a, blood ALT/AST levels > 5 times the upper limit of normal on laboratory results, pregnant or lactating women, history of alcohol or drug addiction in the past 5 years, the patients who be intubated less than one hours after admission to hospital. This study will be undertaken at the Loghman Hakim Hospital, Shahid Beheshti University of Medical Sciences. INTERVENTION AND COMPARATOR: COVID- 19 confirmed patients (using the RT-PCR test or CT scan) will be randomly assigned to one of two groups. The intervention group (Arms1) will be treated with lopinavir / ritonavir (Kaletra) + high dose Interferon-ß 1a (Recigen) and the control group will be treated with lopinavir / ritonavir (Kaletra) + low dose Interferon-ß 1a (Recigen) (the base therapeutic regimen). Both groups will receive standard care consisting of the necessary oxygen support, non-invasive, or invasive mechanical ventilation. MAIN OUTCOMES: Primary outcome: Time to clinical improvement is our primary outcome measure. This is an improvement of two points on a seven-category ordinal scale (recommended by the World Health Organization: Coronavirus disease (COVID-2019) R&D. Geneva: World Health Organization) or discharge from the hospital, whichever comes first. SECONDARY OUTCOMES: mortality from the date of randomization until the last day of the study which will be the day all of the patients have had at least one of the following outcomes: 1) Improvement of two points on a seven-category ordinal scale. 2) Discharge from the hospital 3) Death. Improvement of SPO2 during the hospitalization, duration of hospitalization from date of randomization until the date of hospital discharge or death, whichever comes first. The incidence of new mechanical ventilation uses from the date of randomization until the last day of the study and the duration of it will be extracted. Please note that we are trying to add further secondary outcomes and this section of the protocol is still evolving. RANDOMIZATION: Eligible patients with confirmed SARS-Cov-2 infections will be randomly assigned in a 1:1 ratio to two therapeutic arms using permuted, block-randomization to balance the number of patients allocated to each group. The permuted block (three or six patients per block) randomization sequence will be generated, using Package 'randomizeR' in R software version 3.6.1. and placed in individual sealed and opaque envelopes by the statistician. The investigator will enroll the patients and only then open envelopes to assign patients to the different treatment groups. This method of allocation concealment will result in minimum selection and confounding biases. BLINDING (MASKING): The present research is open-label (no masking) of patients and health care professionals who are undertaking outcome assessment of the primary outcome - time to clinical improvement. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): Of the 100 patients randomised, 50 patients will be assigned to receive high dose Interferon beta-1a plus lopinavir/ritonavir (Kaletra), 50 patients will be assigned to receive low dose Interferon beta 1a plus lopinavir/ritonavir (Kaletra). TRIAL STATUS: Protocol version 1.2.1. Recruitment is finished, the start date of recruitment was on August 20th 2020, and the end date was on September 4th 2020. Last point of data collection will be the last day on which all of the 100 participants have had an outcome of clinical improvement or death, up to 14th days after hospitalization. TRIAL REGISTRATION: This study was registered with National Institutes of Health Clinical trials ( www.clinicaltrials.gov ; identification number NCT04521400, https://clinicaltrials.gov/ct2/show/NCT04521400 , registered August 18, 2020 and first available online August 20, 2020). FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.


Subject(s)
Antiviral Agents/therapeutic use , Betacoronavirus/drug effects , Coronavirus Infections/drug therapy , Interferon beta-1a/therapeutic use , Pneumonia, Viral/drug therapy , Adult , Antiviral Agents/administration & dosage , COVID-19 , Case-Control Studies , Coronavirus Infections/epidemiology , Coronavirus Infections/virology , Dose-Response Relationship, Drug , Drug Combinations , Humans , Interferon beta-1a/administration & dosage , Lopinavir/administration & dosage , Lopinavir/therapeutic use , Mortality/trends , Outcome Assessment, Health Care , Pandemics , Patient Discharge , Pneumonia, Viral/epidemiology , Pneumonia, Viral/virology , Respiration, Artificial/statistics & numerical data , Ritonavir/administration & dosage , Ritonavir/therapeutic use , SARS-CoV-2
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