Categorical variables were compared using the ChiCsquare test. administration of pentaglobin in COVID ?19 patients has no significant effect in reducing the risk of mechanical ventilation or death, in disease worsening or in reduction of inflammation. strong class=”kwd-title” Keywords: SAR-COV-2, Pentaglobin, COVID-19, Immunomodulation 1.?Introduction A novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS- CoV- 2), was first identified in December 2019 in Wuhan, china as the cause of a respiratory illness designated coronavirus disease 2019, or Covid-19 . As of 24 March 2021, more than?124?million cases?have been confirmed, with?more than 2.74?million deaths?attributed to COVID-19 . Several therapeutic agents have been evaluated for the treatment of Covid-19 and trials are ongoing . You will find increasing evidence that SARS\CoV\2 contamination triggers massive influx of activated immune cells to the lungs which leads to a systemic inflammatory response syndrome in Covid 19 pneumonia. As this inflammatory response is the major cause of morbidity and mortality, drugs targeting inflammation have gained Malic enzyme inhibitor ME1 much interest . Pentaglobin is usually a commercially available Intravenous immunoglobin specifically enriched with immunoglobulin (IgM) and it has been reported as a relevant immunomodulant therapy in several infectious diseases, with improvement in clinical course of the illness . We hypothesized that early intervention with pentaglobin in severe Covid-19 pneumonia patients, might limit the progression to hypoxemic respiratory failure or death and reduce the risk of clinical worsening. 2.?Materials and methods 2.1. Study design and treatment protocol: This is an open-label Malic enzyme inhibitor ME1 non-randomised controlled study conducted in a tertiary cardiac care hospital caring COVID-19 patients. The study was carried out after obtaining institutional ethics committee approval. The patients details with full medical history, chronic comorbidities, demographic and epidemiological data were obtained on admission. Malic enzyme inhibitor ME1 Informed consent to participate in the study was obtained. Patients??18?years of age with severe COVID-19 pneumonia documented by positive Reverse transcription polymerase chain reaction (RT-PCR) nasopharyngeal swab or with a CT-chest showing evidence of ground glass opacity requiring high dependency unit admission were considered eligible for the study. Clinical data, including symptoms, baseline heat, chest x-ray, total blood count, coagulation parameters, inflammatory and biochemical markers were obtained. The following were considered as inclusion criteria 1) Spo2? ?94% while breathing ambient air flow.2) the need for Malic enzyme inhibitor ME1 mechanical ventilation 3) tachypnea with respiratory rate??28 breaths per minute. Exclusion criteria included 1) known hypersensitivity reactions to human immunoglobulin 2) pregnant/breast feeding women 3) End stage renal disease 4) chronic liver disease (child pugh C) 5) Glasgow coma level? ?8 on admission. Thirty six patients were enrolled and were divided into 2 groups, the intravenous immunoglobulin (IVIG) group and the control group. The IVIG group (17 cases) were treated with IVIG enriched with IgM (Pentaglobin, Biotest AG, Dreieich, Germany) in addition to standard of care treatment according to the regional COVID-19 guidelines. 5?ml/kg/day of Injection Pentaglobin? (38?g/l IgG, 6?g/l IgM and 6?g/l IgA) was started as an intravenous infusion over a period of 6?h on the day of admission to ICU after confirmation of COVID ?19 pneumonia and repeated for 3 consecutive days. The control group (19 cases) were treated only with standard of care treatment. Injection Remdesivir was administered intravenously as a 200-mg loading dose on day 1, followed by a 100-mg maintenance dose administered daily for next 4?days. In addition, all patients received oxygen supply to target SpO2 reaching? 95%, Azithromycin 500?mg once per day for 5?days, Malic enzyme inhibitor ME1 IV antibiotics at the physicians discretion when suspecting a bacterial respiratory superinfection, Dexamethasone 6?mg daily for 10?days, Vitamin C 1 gm daily and low molecular excess weight heparin for prophylaxis of deep vein thrombosis according to bodyweight and renal function. 3.?Clinical severity and radiological assessment The severity of illness were assessed using Subsequent Organ Failure Assessment (SOFA) score, Acute physiology and chronic health evaluation II (APACHE II) score, Simplified acute physiology score II (SAPS TNFSF10 II) score and quick covid ?19 severity index score (q CSI) launched during the COVID 19 pandemic. Mental status of all patients were assessed using Glasgow coma score. The chest CT-severity score (CTSS) was defined by summing up individual scores from 20 lung regions, with scores of 0, 1, and 2 respectively assigned for each region, if parenchymal opacification involved 0%, 50%, or equal to or more than 50% of each region. A CT-SS.
Categorical variables were compared using the ChiCsquare test