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1.
J Med Virol ; 94(1): 349-356, 2022 01.
Article in English | MEDLINE | ID: covidwho-1427138

ABSTRACT

Corticosteroid dosing in the range of 0.5-2 mg/kg/day of methylprednisolone equivalents has become a standard part of the management of intensive care unit (ICU) patients with COVID-19 pneumonia based on positive results of randomized trials and a meta-analysis. Alongside such conventional dosing, administration of 1 gm of methylprednisolone daily (pulse dosing) has also been reported in the literature with claims of favorable outcomes. Comparisons between such disparate approaches to corticosteroids for Coronavirus disease 2019 (COVID-19) pneumonia are lacking. In this retrospective study of patients admitted to the ICU with COVID-19 pneumonia, we compared patients treated with 0.5-2 mg/kg/day in methylprednisolone equivalents (high-dose corticosteroids) and patients treated with 1 gm of methylprednisolone (pulse-dose corticosteroids) to those who did not receive any corticosteroids. The endpoints of interest were hospital mortality, ICU-free days at Day 28, and complications potentially attributable to corticosteroids. Pulse-dose corticosteroid therapy was associated with a significant increase in ICU-free days at Day 28 compared to no receipt: adjusted relative risk (aRR): 1.45 (95% confidence interval [CI]: 1.05-2.02; p = 0.03) and compared with high-dose corticosteroid administration (p = 0.003). Nonetheless, receipt of high-dose corticosteroids-but not of pulse-dose corticosteroids-significantly reduced the odds of hospital mortality compared to no receipt: adjusted Odds ratio (aOR) 0.31 (95% CI: 0.12-0.77; p = 0.01). High-dose corticosteroids reduced mortality compared to pulse-dose corticosteroids (p = 0.04). Pulse-dose corticosteroids-but not high-dose corticosteroids-significantly increased the odds of acute kidney injury requiring renal replacement therapy compared to no receipt: aOR 3.53 (95% CI: 1.27-9.82; p = 0.02). The odds of this complication were also significantly higher in the pulse-dose group when compared to the high-dose group (p = 0.05 for the comparison). In this single-center study, pulse-dose corticosteroid therapy for COVID-19 pneumonia in the ICU was associated with an increase in ICU-free days but failed to impact hospital mortality, perhaps because of its association with development of severe renal failure. In line with existing trial data, the effect of high-dose corticosteroids on mortality was favorable.


Subject(s)
Acute Kidney Injury/chemically induced , Adrenal Cortex Hormones/therapeutic use , COVID-19/drug therapy , COVID-19/mortality , Methylprednisolone/therapeutic use , Pulse Therapy, Drug/adverse effects , Acute Kidney Injury/epidemiology , Adrenal Cortex Hormones/administration & dosage , Adrenal Cortex Hormones/adverse effects , Critical Care/methods , Hospital Mortality , Humans , Methylprednisolone/administration & dosage , Methylprednisolone/adverse effects , Pulse Therapy, Drug/methods , Retrospective Studies , SARS-CoV-2/drug effects
2.
Ocul Immunol Inflamm ; 29(6): 1212-1215, 2021 Aug 18.
Article in English | MEDLINE | ID: covidwho-1402198

ABSTRACT

A 54-year-old Chinese male with no previous ocular history presented to the ophthalmology department for the bilateral acute painless blurring of vision after receiving the 1st dose of COVID-19 mRNA vaccine (PFIZER-BioNTech/COMIRNATY). Clinical examination and imaging tests were consistent with Vogt-Koyanagi-Hara disease. The patient responded well with a high dose of intravenous methylprednisolone followed by a tapering dose of oral prednisolone.


Subject(s)
/adverse effects , COVID-19/prevention & control , SARS-CoV-2 , Uveomeningoencephalitic Syndrome/etiology , Vaccination/adverse effects , Autoimmunity , Fluorescein Angiography , Glucocorticoids/therapeutic use , Humans , Male , Methylprednisolone/therapeutic use , Middle Aged , Pulse Therapy, Drug , Tomography, Optical Coherence , Uveomeningoencephalitic Syndrome/diagnosis , Uveomeningoencephalitic Syndrome/drug therapy
3.
Clin Exp Nephrol ; 26(1): 75-85, 2022 Jan.
Article in English | MEDLINE | ID: covidwho-1372798

ABSTRACT

BACKGROUND: Critical coronavirus disease 2019 (COVID-19) has a high fatality rate, especially in hemodialysis (HD) patients, with this poor prognosis being caused by systemic hyperinflammation; cytokine storms. Steroid pulse therapy or tocilizumab (TCZ) have insufficient inhibitory effects against cytokine storms in critical cases. This study evaluated the clinical effects and safety of combining steroid pulse therapy and TCZ. METHODS: From September 2020 to May 2021, 201 patients with COVID-19 were admitted to our hospital. Before February 2021, patients with an oxygen demand exceeding 8 L/min were intubated and treated with standard therapy (dexamethasone and antiviral therapy). After February 2021, patients underwent high-flow nasal cannula oxygen therapy and were treated with TCZ (8 mg/kg) and methylprednisolone (mPSL) (500 mg/day [≤ 75 kg], 1000 mg/day [> 75 kg]) for 3 days. We compared background characteristics, laboratory findings, and prognosis between non-HD and HD patients and between patients who received and did not receive TCZ and mPSL pulse therapy. RESULTS: Among non-HD patients, the TCZ + mPSL pulse group had significantly higher survival rates and lower secondary infection rates (p < 0.05), than the standard therapy group. All HD patients in the standard therapy group with oxygen demand exceeding 8 L/min died. Contrastingly, all patients in the TCZ + mPSL pulse group survived, with their oxygen demand decreasing to 0-1 L/min within 3 weeks post-administration. CONCLUSION: TCZ combined with mPSL pulse therapy improved the survival rate without significant adverse events in critical HD and non-HD patients with COVID-19 by strongly suppressing systemic hyperinflammation.


Subject(s)
Anti-Inflammatory Agents/therapeutic use , Antibodies, Monoclonal, Humanized/therapeutic use , COVID-19/drug therapy , Cytokine Release Syndrome/prevention & control , Glucocorticoids/administration & dosage , Kidney Diseases/therapy , Methylprednisolone/administration & dosage , Renal Dialysis , Adult , Aged , Aged, 80 and over , Anti-Inflammatory Agents/adverse effects , Antibodies, Monoclonal, Humanized/adverse effects , COVID-19/diagnosis , COVID-19/immunology , COVID-19/mortality , Cytokine Release Syndrome/diagnosis , Cytokine Release Syndrome/immunology , Cytokine Release Syndrome/mortality , Drug Therapy, Combination , Female , Glucocorticoids/adverse effects , Humans , Kidney Diseases/diagnosis , Kidney Diseases/immunology , Kidney Diseases/mortality , Male , Methylprednisolone/adverse effects , Middle Aged , Pulse Therapy, Drug , Renal Dialysis/adverse effects , Renal Dialysis/mortality , Retrospective Studies , Time Factors , Treatment Outcome
4.
BMC Pregnancy Childbirth ; 21(1): 567, 2021 Aug 18.
Article in English | MEDLINE | ID: covidwho-1365335

ABSTRACT

BACKGROUND: Coronavirus disease 2019 (COVID-19) still is a global emergency. According to the studies, pregnant women are of the at risk populations and any underlying disease(s) might even worsen their condition. The aim of this study is reporting a complex case of immune thrombocytopenic purpura (ITP) during pregnancy who has been diagnosed with COVID-19 as well as suspicion of HELLP syndrome. CASE PRESENTATION: A 24-year-old woman with a platelet count of 6000/mL and resistance to conventional therapies was referred. A day after starting 0.5 g/day of methylprednisolone for her, fever and a decrease in SpO2 presented. According to the paraclinical investigations, COVID-19 was diagnosed and the conventional COVID-19 treatments started for her (the methylprednisolone pulse stopped). Due to the increased liver enzymes and low platelet count, with suspicion of HELLP syndrome, cesarean section surgery was performed which resulted in a healthy neonate. Then, the methylprednisolone pulse was restarted for and she developed an increase in the platelet count. CONCLUSION: It is not clear how COVID-19 and pregnancy affected the patient's condition and the underlying disease; however, it seems the delivery and/or restarting the methylprednisolone pulses caused improvement in her condition.


Subject(s)
COVID-19/diagnosis , Methylprednisolone/administration & dosage , Pregnancy Complications, Hematologic/drug therapy , Pregnancy Complications, Infectious/diagnosis , Purpura, Thrombocytopenic, Idiopathic/drug therapy , Antiviral Agents/therapeutic use , COVID-19/complications , COVID-19/drug therapy , COVID-19/virology , Cesarean Section , Drug Resistance , Female , HELLP Syndrome/diagnosis , Humans , Infant, Newborn , Male , Platelet Count , Pregnancy , Pregnancy Complications, Hematologic/blood , Pregnancy Complications, Hematologic/diagnosis , Pregnancy Complications, Infectious/drug therapy , Pregnancy Complications, Infectious/virology , Pulse Therapy, Drug , Purpura, Thrombocytopenic, Idiopathic/blood , Purpura, Thrombocytopenic, Idiopathic/complications , Purpura, Thrombocytopenic, Idiopathic/diagnosis , SARS-CoV-2/isolation & purification , Treatment Outcome , Young Adult
5.
Ocul Immunol Inflamm ; 29(6): 1200-1206, 2021 Aug 18.
Article in English | MEDLINE | ID: covidwho-1360249

ABSTRACT

PURPOSE: To describe a case of acute thyroiditis and bilateral optic neuritis associated with SARS-CoV-2 vaccination. METHODS: A single case report from a tertiary referral center. RESULTS: The patient described in the following case report developed acute thyroiditis and bilateral optic neuritis following SARS-CoV-2 vaccination. The patient underwent pulse therapy followed by oral tapering corticosteroid therapy with an improvement of the bilateral disc swelling and the visual field, and recovery of thyroid-stimulating hormone to the normal limits. CONCLUSION: Although the association between immunization and the onset of demyelinating manifestations of the central nervous system is well documented, this is the first reported case of bilateral optic neuritis and acute thyroiditis and subsequent to administration of vaccination against SARS-CoV-2.


Subject(s)
COVID-19 Vaccines/adverse effects , COVID-19/prevention & control , Optic Neuritis/etiology , SARS-CoV-2 , Thyroiditis/etiology , Vaccination/adverse effects , Acute Disease , Adult , Female , Glucocorticoids/therapeutic use , Humans , Magnetic Resonance Imaging , Optic Neuritis/diagnosis , Optic Neuritis/drug therapy , Orbit/diagnostic imaging , Pulse Therapy, Drug , Thyroiditis/diagnosis , Thyroiditis/drug therapy , Tomography, Optical Coherence , Visual Acuity/physiology
6.
Pediatr Rheumatol Online J ; 19(1): 104, 2021 Jun 30.
Article in English | MEDLINE | ID: covidwho-1292002

ABSTRACT

BACKGROUND: H syndrome (HS) is a rare autoinflammatory disease caused by a mutation in the solute carrier family 29, member 3 (SCL29A3) gene. It has a variable clinical presentation and little phenotype-genotype correlation. The pathognomonic sign of HS is cutaneous hyperpigmentation located mainly in the inner thighs and often accompanied by other systemic manifestations. Improvement after tocilizumab treatment has been reported in a few patients with HS. We report the first patient with HS who presented cardiogenic shock, multiorgan infiltration, and digital ischemia. CASE PRESENTATION: 8-year-old boy born to consanguineous parents of Moroccan origin who was admitted to the intensive care unit during the Coronavirus Disease-2019 (COVID-19) pandemic with tachypnoea, tachycardia, and oliguria. Echocardiography showed dilated cardiomyopathy and severe systolic dysfunction compatible with cardiogenic shock. Additionally, he presented with multiple organ dysfunction syndrome. SARS-CoV-2 polymerase chain reaction (PCR) and antibody detection by chromatographic immunoassay were negative. A previously ordered gene panel for pre-existing sensorineural hearing loss showed a pathological mutation in the SCL29A3 gene compatible with H syndrome. Computed tomography scan revealed extensive alveolar infiltrates in the lungs and multiple poor defined hypodense lesions in liver, spleen, and kidneys; adenopathy; and cardiomegaly with left ventricle subendocardial nodules. Invasive mechanical ventilation, broad antibiotic and antifungal coverage showed no significant response. Therefore, Tocilizumab as compassionate use together with pulsed intravenous methylprednisolone was initiated. Improvement was impressive leading to normalization of inflammation markers, liver and kidney function, and stabilising heart function. Two weeks later, he was discharged and has been clinically well since then on two weekly administration of Tocilizumab. CONCLUSIONS: We report the most severe disease course produced by HS described so far in the literature. Our patient's manifestations included uncommon, new complications such as acute heart failure with severe systolic dysfunction, multi-organ cell infiltrate, and digital ischemia. Most of the clinical symptoms of our patient could have been explained by SARS-CoV-2, demonstrating the importance of a detailed differential diagnosis to ensure optimal treatment. Although the mechanism of autoinflammation of HS remains uncertain, the good response of our patient to Tocilizumab makes a case for the important role of IL-6 in this syndrome and for considering Tocilizumab as a first-line treatment, at least in severely affected patients.


Subject(s)
Cardiomyopathy, Dilated/physiopathology , Hereditary Autoinflammatory Diseases/physiopathology , Ischemia/physiopathology , Multiple Organ Failure/physiopathology , Shock, Cardiogenic/physiopathology , Antibodies, Monoclonal, Humanized/therapeutic use , COVID-19 , Cardiomyopathy, Dilated/diagnostic imaging , Cardiomyopathy, Dilated/therapy , Child , Glucocorticoids/therapeutic use , Hereditary Autoinflammatory Diseases/diagnosis , Hereditary Autoinflammatory Diseases/genetics , Hereditary Autoinflammatory Diseases/therapy , Humans , Ischemia/therapy , Kidney Diseases/diagnostic imaging , Kidney Diseases/physiopathology , Kidney Diseases/therapy , Liver Diseases/diagnostic imaging , Liver Diseases/physiopathology , Liver Diseases/therapy , Lung Diseases/diagnostic imaging , Lung Diseases/physiopathology , Lung Diseases/therapy , Lymphadenopathy/diagnostic imaging , Lymphadenopathy/physiopathology , Lymphadenopathy/therapy , Male , Methylprednisolone/therapeutic use , Multiple Organ Failure/therapy , Nucleoside Transport Proteins/genetics , Pulse Therapy, Drug , Respiration, Artificial , SARS-CoV-2 , Shock, Cardiogenic/therapy , Splenic Diseases/diagnostic imaging , Splenic Diseases/physiopathology , Splenic Diseases/therapy , Toes/blood supply , Tomography, X-Ray Computed , Treatment Outcome
7.
Pan Afr Med J ; 38: 273, 2021.
Article in English | MEDLINE | ID: covidwho-1248412

ABSTRACT

Coronavirus 2019 disease (COVID-19) is a deadly disease that was first seen in Wuhan, China, and primarily affects the respiratory system, but also has different systemic involvements. It has caused 89 million cases and 1.9 million deaths worldwide. COVID-19 positive renal transplant recipients have a higher mortality rate than COVID-19 patients in the normal population. There is no specific treatment and follow-up protocol for COVID-19 infection in transplant recipients. COVID-19 treatment and immunosuppressive therapy choices are controversial. Recently, pulse steroid therapies have been used in cases with severe COVID-19 pneumonia. Convalescent plasma therapy is used limitedly in COVID-19 patients. Our 49-year-old male patient has been a recipient of a renal transplant from a cadaver for 6 years. We aimed to make an additional contribution by presenting our patient to the literature whose COVID-19 PCR-RT test performed in the emergency department due to the complaints of fever, shortness of breath, and cough for five days was positive and had moderate COVID-19 pneumonia in thorax tomography and had serious clinical and radiological improvement after pulsed methylprednisolone and convalescent plasma therapy in the early period.


Subject(s)
COVID-19/therapy , Methylprednisolone/administration & dosage , Pneumonia, Viral/therapy , COVID-19/complications , COVID-19/diagnosis , COVID-19/drug therapy , Combined Modality Therapy , Glucocorticoids/administration & dosage , Humans , Immunization, Passive , Kidney Transplantation , Male , Middle Aged , Pneumonia, Viral/etiology , Pulse Therapy, Drug , Transplant Recipients , Treatment Outcome
8.
Turk J Med Sci ; 51(5): 2248-2255, 2021 10 21.
Article in English | MEDLINE | ID: covidwho-1196053

ABSTRACT

Background/aim: High-dose steroid has been shown to reduce the mortality rate in Corona virus disease 2019 (COVID-19) patients who need oxygen support. Here, we evaluated the effectiveness of pulse-steroid in case of unresponsiveness to treatment with high dose steroid. Materials and methods: The study is a retrospective controlled trial. We divided the patients in 3 groups: standard-care therapy alone, high-dose steroid treatment (6 mg/day dexamethasone equivalent), and pulse-steroid treatment (250 mg/day methyl-prednisolone). One hundred and fifty patients were enrolled in each group. All patients were hospitalized and needed oxygen support. We matched the patients according to disease severity at the onset of hypoxia, weight of co-morbidities, age, and sex. We then compared 3 groups in terms of mortality, length of hospitalization, need for intensive care unit (ICU) admission and mechanical ventilation (MV), length of stay in ICU, and duration of MV. Results: The pulse-steroid group had shorter ICU stay. The median ICU stay was 9.0 (CI 95% 6.0­12.0) days in standard-care group, 8.0 (CI 95% 5.0­13.0) days in high-dose steroid group and 4.5(CI %95 3.0­8.0) days in pulse-steroid group. Moreover, although patients in pulse-steroid group were initially unresponsive to high dose steroid therapy, they achieved similar results compared to the high-dose steroid group in other outcomes except for length of hospital stay. Conclusion: Pulse-steroid treatment would be an option for COVID-19 patients who do not respond to the initial high-dose steroid treatment.


Subject(s)
COVID-19/drug therapy , Dexamethasone/administration & dosage , Glucocorticoids/administration & dosage , Methylprednisolone/administration & dosage , Aged , Female , Hospitalization , Humans , Male , Middle Aged , Pulse Therapy, Drug , Retrospective Studies , Treatment Outcome
9.
Clin Neurol Neurosurg ; 203: 106563, 2021 Apr.
Article in English | MEDLINE | ID: covidwho-1082985

ABSTRACT

BACKGROUND: Iran is one of the countries with a high prevalence of multiple sclerosis (MS) and COVID-19.MS patients receiving the immunomodulatory or immunosuppressive therapy have a higher risk of infection. Due to the significance of determining the risk factors for getting COVID-19 among MS patients, the present study was designed to assess the risk of infection following the pulse steroid therapy. METHODS: This cross-sectional study included all MS patients that received corticosteroids in Tehran from December 2019 to August 2020 during the COVID-19 pandemic spread. The subjects' clinical records including their sex, age, the type of MS, the type of medication, the number of days using corticosteroids, the status of prednisolone intake, and the number of days receiving prednisolone after the corticosteroid therapy were obtained. Moreover, main outcomes such as COVID-19 infection and the occurrence of death were recorded by patient's visits and follow-up phone calls. COVID-19 infection was confirmed by physicians according to the clinical performance of RT-PCR, chest CT scan, and antibody tests. RESULTS: Totally, 133 MS cases participated in the study, and the pulse therapy was completed for 104 (78.2%) patients up to 5-7 days. 89 (66.9%) cases used the prednisolone tablet following the pulse therapy. Overall, the infection by Covid-19 was observed in 8 (6%) cases, among whom 5 (71.4%) cases received the pulse therapy for 5-7 days and 4 (57.1%) cases had a history of taking the prednisolone tablet. The age of less than 40 years (OR = 1.03; 95% CI (0.23-4.51)), male sex (OR = 0.35; 95% CI (0.03-3.34)), and the RRMS type (OR = 2.87; 95% CI (0.52-15.72)) had no effect on the risk of Covid-19 infection. In addition, there was not statistically significant difference between subjects with the short-term pulse therapy duration (3-4 days) (OR 0.68 (0.12-3.74) and those with the long-term pulse therapy duration (5-7 days). Similarly, no statistically significant difference was observed between subjects taking prednisolone (OR = 1.62 (0.34-7.61) and those not taking prednisolone. Furthermore, there was no significant association between different medication groups and the risk of Covid-19 infection (p < 0.05). No death occurred due to Covid-19 infection among the subjects. CONCLUSION: COVID-19 infection was more common among female and younger patients as well as patients with a longer duration of the pulse therapy and prednisolone intake. There was no significant association between the pulse steroid therapy in MS patients and the risk of infection by COVID-19 in the Iranian population.


Subject(s)
Adrenal Cortex Hormones/administration & dosage , COVID-19/epidemiology , Multiple Sclerosis/drug therapy , Adult , Anti-Inflammatory Agents/administration & dosage , COVID-19/diagnosis , Cross-Sectional Studies , Female , Humans , Iran , Male , Middle Aged , Multiple Sclerosis/complications , Prednisolone/administration & dosage , Pulse Therapy, Drug
10.
Pediatr Nephrol ; 36(4): 1019-1023, 2021 04.
Article in English | MEDLINE | ID: covidwho-1047246

ABSTRACT

BACKGROUND: Coronavirus disease 2019 (COVID-19) is thought to cause kidney injury via a variety of mechanisms. The most common reported kidney injury following COVID-19 infection is acute tubular injury (ATI); however, the procoagulant state induced by the virus may also damage the kidneys. CASE-DIAGNOSIS/TREATMENT: Herein, we report two cases of acute necrotizing glomerulonephritis (GN) with fibrinoid necrosis in the context of COVID-19 infection. The one with more chronic features in the kidney biopsy progressed to permanent kidney failure but the second one had an excellent response to glucocorticoid pulse therapy with subsequent normal kidney function at 2-month follow-up. CONCLUSIONS: Both reported cases had an acute presentation of kidney injury with positive nasopharyngeal PCR test for COVID-19. Based on the data review by the researchers, this is the first report of acute necrotizing GN associated with COVID-19 infection.


Subject(s)
Acute Kidney Injury/etiology , COVID-19/complications , Glomerulonephritis/etiology , Kidney Glomerulus/pathology , SARS-CoV-2/pathogenicity , Acute Kidney Injury/pathology , Acute Kidney Injury/therapy , Adolescent , Biopsy , Blood Coagulation , COVID-19/blood , COVID-19/diagnosis , COVID-19/virology , Glomerulonephritis/pathology , Glomerulonephritis/therapy , Glucocorticoids/administration & dosage , Humans , Kidney Glomerulus/blood supply , Male , Necrosis/immunology , Necrosis/pathology , Platelet Count , Pulse Therapy, Drug , Renal Dialysis , SARS-CoV-2/isolation & purification , Treatment Outcome
12.
Trials ; 22(1): 43, 2021 Jan 11.
Article in English | MEDLINE | ID: covidwho-1021413

ABSTRACT

OBJECTIVES: The aim of this study is to assess the effectiveness and safety of glucocorticoid infusion pulse therapy to improve the clinical outcomes of patients with COVID-19 pneumonia with elevated inflammatory biomarkers. TRIAL DESIGN: A parallel-group quadruple-blind (participant, intervention provider, outcome assessor and data manager), randomised controlled trial. PARTICIPANTS: All patients admitted to hospital due to COVID-19 pneumonia will be considered eligible. Potential candidates will be identified and consecutively included in the emergency room or in the COVID-19 admission wards of two hospitals in Spain: Complejo Hospitalario de Navarra (Pamplona) and Hospital Moisès Broggi (Sant Joan Despí, Barcelona). Inclusion criteria are: 1) age ≥18 years old; 2) diagnosis of SARS-CoV-2 pneumonia confirmed by reverse transcriptase polymerase chain reaction (RT-PCR) of nasopharyngeal swabs or sputum in accordance with the recommendations of the Spanish Ministry of Health; 3) history of symptoms compatible with COVID-19 ≥7 days; 4) hospital admission; 5) at least one of the following: C-reactive protein (CRP) >60 mg/dL, interleukin-6 (IL-6) >40 pg/mL, and/or ferritin >1000 µg/L; and 6) provision of informed consent. Exclusion criteria are: 1) allergy or contraindication to any of the drugs under study; 2) oxygen saturation (SpO2) <90% (in air ambient) or partial pressure of oxygen in arterial blood (PaO2) <60 mmHg (in ambient air) or PaO2/FiO2 <300 mmHg; 3) ongoing treatment with glucocorticoids, or other immunosuppressants, including biologics for another indication; 4) decompensated diabetes mellitus; 5) uncontrolled hypertension; 6) psychotic or manic disorder; 7) active cancer; 8) pregnancy or breastfeeding; 9) clinical or biochemical suspicion (procalcitonin >0.5 ng/mL) of active infection other than with SARS-CoV-2; 10) management as an outpatient; 11) conservative or palliative management; 12) participation in another clinical trial; or 13) any major uncontrolled medical, psychological, psychiatric, geographic or social problem that contraindicates the patient's participation in the trial or hinders proper follow-up and adherence to the protocol and evaluation of study outcomes. INTERVENTION AND COMPARATOR: Eligible patients will be randomised to receive standard of care plus methylprednisolone (intervention group) or standard of care plus placebo (control group). Intervention group: standard of care at the discretion of the researcher, including lopinavir/ritonavir (200/50 mg, 2 tablets twice daily, per os, for 7 to 14 days) ± remdesivir (a single intravenous loading dose of 200 mg on day 1 followed by once-daily intravenous maintenance doses of 100 mg from day 2 to 5), or no drug treatment, + methylprednisolone (once-daily intravenous infusion of 120 mg on days 1, 2 and 3). CONTROL GROUP: standard of care at the discretion of the researcher, including lopinavir/ritonavir (200/50 mg, 2 tablets every 12 hours, per os, for 7 to 14 days) ± remdesivir (a single intravenous loading dose of 200 mg on day 1 followed by once-daily intravenous maintenance doses of 100 mg from day 2 to 5), or no drug treatment, + placebo (once-daily intravenous infusion of 100 mL of 0.9% saline on days 1, 2 and 3). MAIN OUTCOMES: The primary outcome is the proportion of patients with treatment failure at 14 days after randomisation, defined as: 1) death, 2) need for admission to an intensive care unit (ICU), 3) initiation of mechanical ventilation, 4) SpO2 falling to <90% (in ambient air) or PaO2 <60 mmHg (in ambient air) or PaO2FiO2 <300 mmHg, not explained by a cause other than COVID-19, and/or 5) decrease in PaO2 ≥15% from baseline, together with laboratory and radiological deterioration. RANDOMISATION: Treatment will be allocated by block randomisation stratified by patient age (< or ≥ 75 years of age). For this purpose, we will use the R randomizeR package using two block sizes (4 and 6) with random permutation. The randomisation sequence will be generated by a unit (the Navarrabiomed Clinical Trials Platform) independent from the researchers who will recruit patients and implement the protocol. BLINDING (MASKING): The study will be quadruple-blinded, specifically, with blinding of patients, intervention providers, outcome assessors and data managers. The pharmacy at each participating hospital will prepare indistinguishable bags of methylprednisolone or placebo (0.9% saline) for patients of the experimental and placebo groups, respectively. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): The percentage of patients with treatment failure (primary endpoint) is currently unknown. Assuming an absolute difference of 25% in the primary outcome between the two groups (35% in the control group and 10% in the intervention group), we estimate that 60 patients (30 per group) are required to detect this difference with a two-tailed type I error of 0.05 and a type II error of 0.2. Estimating a loss to follow-up of 20%, we should recruit a total sample size of 72 patients (36 per group). TRIAL STATUS: The Spanish Agency of Medicines and Medical Devices (AEMPS) and the Ethics Committee of the University Hospital La Princesa approved version 7.0 of the protocol on 30 April 2020 as a low intervention clinical trial. Subsequently, the protocol has been amended by researchers and re-approved by AEMPS and the same ethics committee on 1 July 2020 (version 8.0) and on 28 August 2020 (version 9.0). Currently, the trial is in the recruitment phase. Recruitment began on 28 May 2020 and is expected to be completed by February 2021. TRIAL REGISTRATION: This study protocol was registered on the eudract.ema.europa.eu on 5 May 2020 (title "Early treatment of COVID-19 pneumonia with glucocorticoids. Randomized controlled clinical trial"; EudraCT Number: 2020-001827-15 ) and on clinicaltrials.gov on 19 June 2020 (title: "Glucocorticoids in COVID-19 (CORTIVID)"; identifier: NCT04438980 ). FULL PROTOCOL: The full protocol (version 9.0) 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)
COVID-19/drug therapy , Glucocorticoids/therapeutic use , Methylprednisolone/therapeutic use , C-Reactive Protein/metabolism , COVID-19/metabolism , Double-Blind Method , Ferritins/metabolism , Hospitalization , Humans , Infusions, Intravenous , Interleukin-6/metabolism , Pulse Therapy, Drug , Randomized Controlled Trials as Topic , SARS-CoV-2 , Treatment Outcome
13.
Eur Respir J ; 56(6)2020 12.
Article in English | MEDLINE | ID: covidwho-781426

ABSTRACT

INTRODUCTION: There are no determined treatment agents for severe COVID-19. It is suggested that methylprednisolone, as an immunosuppressive treatment, can reduce the inflammation of the respiratory system in COVID-19 patients. METHODS: We conducted a single-blind, randomised controlled clinical trial involving severe hospitalised patients with confirmed COVID-19 at the early pulmonary phase of the illness in Iran. The patients were randomly allocated in a 1:1 ratio by the block randomisation method to receive standard care with methylprednisolone pulse (intravenous injection, 250 mg·day-1 for 3 days) or standard care alone. The study end-point was the time of clinical improvement or death, whichever came first. Primary and safety analysis was done in the intention-to-treat (ITT) population. RESULTS: 68 eligible patients underwent randomisation (34 patients in each group) from April 20, 2020 to June 20, 2020. In the standard care group, six patients received corticosteroids by the attending physician before the treatment and were excluded from the overall analysis. The percentage of improved patients was higher in the methylprednisolone group than in the standard care group (94.1% versus 57.1%) and the mortality rate was significantly lower in the methylprednisolone group (5.9% versus 42.9%; p<0.001). We demonstrated that patients in the methylprednisolone group had a significantly increased survival time compared with patients in the standard care group (log-rank test: p<0.001; hazard ratio 0.293, 95% CI 0.154-0.556). Two patients (5.8%) in the methylprednisolone group and two patients (7.1%) in the standard care group showed severe adverse events between initiation of treatment and the end of the study. CONCLUSIONS: Our results suggest that methylprednisolone pulse could be an efficient therapeutic agent for hospitalised severe COVID-19 patients at the pulmonary phase.


Subject(s)
Anti-Inflammatory Agents/administration & dosage , COVID-19/drug therapy , Methylprednisolone/administration & dosage , Adult , Aged , Female , Hospitalization , Humans , Injections, Intravenous , Male , Middle Aged , Pulse Therapy, Drug , Severity of Illness Index , Single-Blind Method
14.
BMJ Open Respir Res ; 7(1)2020 08.
Article in English | MEDLINE | ID: covidwho-733150

ABSTRACT

Invasive mechanical has been associated with high mortality in COVID-19. Alternative therapy of high flow nasal therapy (HFNT) has been greatly debated around the world for use in COVID-19 pandemic due to concern for increased healthcare worker transmission.This was a retrospective analysis of consecutive patients admitted to Temple University Hospital in Philadelphia, Pennsylvania, from 10 March 2020 to 24 April 2020 with moderate-to-severe respiratory failure treated with HFNT. Primary outcome was prevention of intubation. Of the 445 patients with COVID-19, 104 met our inclusion criteria. The average age was 60.66 (+13.50) years, 49 (47.12 %) were female, 53 (50.96%) were African-American, 23 (22.12%) Hispanic. Forty-three patients (43.43%) were smokers. Saturation to fraction ratio and chest X-ray scores had a statistically significant improvement from day 1 to day 7. 67 of 104 (64.42%) were able to avoid invasive mechanical ventilation in our cohort. Incidence of hospital-associated/ventilator-associated pneumonia was 2.9%. Overall, mortality was 14.44% (n=15) in our cohort with 13 (34.4%) in the progressed to intubation group and 2 (2.9%) in the non-intubation group. Mortality and incidence of pneumonia was statistically higher in the progressed to intubation group. CONCLUSION: HFNT use is associated with a reduction in the rate of invasive mechanical ventilation and overall mortality in patients with COVID-19 infection.


Subject(s)
Coronavirus Infections/therapy , Healthcare-Associated Pneumonia/epidemiology , Hypoxia/therapy , Intubation, Intratracheal/statistics & numerical data , Oxygen Inhalation Therapy/methods , Pneumonia, Viral/therapy , Respiratory Insufficiency/therapy , Adrenal Cortex Hormones/therapeutic use , African Americans , Aged , Anti-Bacterial Agents/therapeutic use , Antibodies, Monoclonal, Humanized/therapeutic use , Antirheumatic Agents/therapeutic use , Azithromycin/therapeutic use , Betacoronavirus , COVID-19 , Cannula , Comorbidity , Coronavirus Infections/epidemiology , Diabetes Mellitus/epidemiology , Female , Heart Diseases/epidemiology , Humans , Hydroxychloroquine/therapeutic use , Hypertension/epidemiology , Immunoglobulins, Intravenous/therapeutic use , Immunologic Factors/therapeutic use , Lung Diseases/epidemiology , Male , Middle Aged , Pandemics , Philadelphia/epidemiology , Pneumonia, Ventilator-Associated/epidemiology , Pneumonia, Viral/epidemiology , Pulse Therapy, Drug , Renal Insufficiency, Chronic/epidemiology , Retrospective Studies , SARS-CoV-2 , Severity of Illness Index , Smoking/epidemiology
15.
Neurologia (Engl Ed) ; 35(6): 357-362, 2020.
Article in English, Spanish | MEDLINE | ID: covidwho-680554

ABSTRACT

INTRODUCTION: The COVID-19 pandemic is changing approaches to diagnosis, treatment, and care provision in multiple sclerosis (MS). During both the initial and peak phases of the epidemic, the administration of disease-modifying drugs, typically immunosuppressants administered in pulses, was suspended due to the uncertainty about their impact on SARS-CoV-2 infection, mainly in contagious asymptomatic/presymptomatic patients. The purpose of this study is to present a safety algorithm enabling patients to resume pulse immunosuppressive therapy (PIT) during the easing of lockdown measures. METHODS: We developed a safety algorithm based on our clinical experience with MS and the available published evidence; the algorithm assists in the detection of contagious asymptomatic/presymptomatic cases and of patients with mild symptoms of SARS-CoV-2 infection with a view to withdrawing PIT in these patients and preventing new infections at day hospitals. RESULTS: We developed a clinical/microbiological screening algorithm consisting of a symptom checklist, applied during a teleconsultation 48hours before the scheduled session of PIT, and PCR testing for SARS-CoV-2 in nasopharyngeal exudate 24hours before the procedure. CONCLUSION: The application of our safety algorithm presents a favourable risk-benefit ratio despite the fact that the actual proportion of asymptomatic and presymptomatic individuals is unknown. Systematic PCR testing, which provides the highest sensitivity for detecting presymptomatic cases, combined with early detection of symptoms of SARS-CoV-2 infection may reduce infections and improve detection of high-risk patients before they receive PIT.


Subject(s)
Algorithms , Betacoronavirus/isolation & purification , Coronavirus Infections/prevention & control , Immunosuppressive Agents/administration & dosage , Multiple Sclerosis/drug therapy , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , Ambulatory Care , Asymptomatic Diseases , COVID-19 , COVID-19 Testing , Checklist , Clinical Laboratory Techniques , Contraindications, Drug , Coronavirus Infections/diagnosis , Disease Susceptibility , Humans , Immunocompromised Host , Immunosuppressive Agents/adverse effects , Immunosuppressive Agents/therapeutic use , Mass Screening/methods , Nasopharynx/virology , Pneumonia, Viral/diagnosis , Polymerase Chain Reaction , Pulse Therapy, Drug , Quarantine , Risk Assessment , SARS-CoV-2 , Symptom Assessment , Telemedicine
16.
Transpl Infect Dis ; 22(6): e13364, 2020 Dec.
Article in English | MEDLINE | ID: covidwho-592352

ABSTRACT

Solid organ transplant recipients are considered at high risk for COVID-19 infection due to chronic immune suppression; little data currently exists on the manifestations and outcomes of COVID-19 infection in lung transplant recipients. Here we report 8 cases of COVID-19 identified in patients with a history of lung transplant. We describe the clinical course of disease as well as preexisting characteristics of these patients.


Subject(s)
COVID-19/physiopathology , Cross Infection/physiopathology , Immunosuppressive Agents/therapeutic use , Lung Transplantation , Adenosine Monophosphate/analogs & derivatives , Adenosine Monophosphate/therapeutic use , Adult , Aged , Alanine/analogs & derivatives , Alanine/therapeutic use , Antibodies, Monoclonal, Humanized/therapeutic use , Antiviral Agents/therapeutic use , COVID-19/diagnostic imaging , COVID-19/immunology , COVID-19/therapy , Cough/physiopathology , Cross Infection/diagnostic imaging , Cross Infection/immunology , Cross Infection/therapy , Cystic Fibrosis/surgery , Dyspnea/physiopathology , Female , Fever/physiopathology , Gastrointestinal Diseases/physiopathology , Glucocorticoids/therapeutic use , Graft Rejection/prevention & control , Humans , Idiopathic Pulmonary Fibrosis/surgery , Immunoglobulins, Intravenous/therapeutic use , Immunologic Factors/therapeutic use , Interleukin 1 Receptor Antagonist Protein/therapeutic use , Lung/diagnostic imaging , Male , Methylprednisolone/therapeutic use , Middle Aged , Pancreatitis, Acute Necrotizing , Pulmonary Disease, Chronic Obstructive/surgery , Pulse Therapy, Drug , SARS-CoV-2 , Sepsis , Severity of Illness Index , Tomography, X-Ray Computed
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