Objectives: Convalescent plasma (CP) as a passive source of neutralizing antibodies and immunomodulators is a century-old therapeutic option used for the management of viral diseases. We investigated its effectiveness for the treatment of COVID-19. Design: Open-label, parallel-arm, phase II, multicentre, randomized controlled trial. Setting: Thirty-nine public and private hospitals across India. Participants: Hospitalized, moderately ill confirmed COVID-19 patients (PaO2/FiO2: 200-300 or respiratory rate > 24/min and SpO2 ≤ 93% on room air). Intervention: Participants were randomized to either control (best standard of care (BSC)) or intervention (CP + BSC) arm. Two doses of 200 mL CP was transfused 24 hours apart in the intervention arm. Main Outcome Measure: Composite of progression to severe disease (PaO2/FiO2<100) or all-cause mortality at 28 days post-enrolment. Results: Between 22 nd April to 14 th July 2020, 464 participants were enrolled; 235 and 229 in intervention and control arm, respectively. Composite primary outcome was achieved in 44 (18.7%) participants in the intervention arm and 41 (17.9%) in the control arm [aOR: 1.09; 95% CI: 0.67, 1.77]. Mortality was documented in 34 (13.6%) and 31 (14.6%) participants in intervention and control arm, respectively [aOR) 1.06 95% CI: -0.61 to 1.83]. Interpretation: CP was not associated with reduction in mortality or progression to severe COVID-19. This trial has high generalizability and approximates real-life setting of CP therapy in settings with limited laboratory capacity. A priori measurement of neutralizing antibody titres in donors and participants may further clarify the role of CP in management of COVID-19.
Background:Incidence of intracerebral hemorrhage (ICH) is twice as high as in Western countries. Prognostic factors for predicting function outcome and mortality play a major role in determining the treatment outcome.Methods:A prospective study of male and female patients ≥12 years with primary nontraumatic intracranial hemorrhage were included. Hemorrhage caused by trauma, anticoagulant or thrombolytic drugs, brain tumor, saccular arterial aneurysm or vascular malformation were excluded. Functional outcome of patients was determined by modified Rankin's scale. Glasgow Coma Scale (GCS) score and ICH score were calculated for each patient.Results:Hypertension was present in 45 out of 49 patients (92%) with ICH of basal ganglia. Hypertension was significantly associated with worst clinical outcome. Mortality was high if the patient was comatose/stuporous compared to drowsy state (P < 0.0001). Mortality was found to be high when the size exceeded 30 cm3. High ICH score, low GCS score at the time of admission, presence of intraventricular hemorrhage, and midline shift were significantly associated with poor clinical outcome.Conclusions:Intracranial hemorrhage can be deleterious if present with low GCS score, high ICH score, intraventricular extension, and midline shift.
Objective The purpose of this study was to examine the effect of herbal formulation - Aayudh Advance on viral load as well as recovery duration in mild symptomatic patients diagnosed with Corona Virus Disease 2019 (COVID-19). It also aimed to study the effect of Herbal formulation – Aayudh Advance in terms of clinical improvement of various sign and symptoms in mild symptomatic COVID-19 patients. Method Once the patient suffice the requirement of inclusion, exclusion criteria of the study than as per the method of ‘Covariate Adaptive Randomization’ technique, patient was assigned in either Aayudh Advance arm (Test arm) or Control Arm. Here standard of Care treatment was given to all patients of both the arms. Treatment was given for the period of 14 days or till patient turned COVID-19 negative, which ever was earlier. Clinical signs and symptoms viz. body temperature, SpO 2, Scoring of Cough & Scoring of Shortness of breath were recorded on all 5 Clinical visits along with biochemical testing like RT-PCR (with CT value of E gene and RDRP gene), serum ferritin, CRP and NLR observed on weekly Visit. Result Total 74 patients were enrolled in the present study. Out of which 60 patients (30 patients in each group) have completed study as per the protocol, whereas 14 patients have voluntarily withdrawn from the study due to getting early discharge from the hospital. All patients in Aayudh Advance treatment group recovered (100%) after 14 days. This observed recovery was 15.38% more as compared to Standard of Care treatment alone. Further, there was statistically significant reduction (p < 0.05) in viral load as indicated by significant increase in CT value of E-gene and RDRP gene. Further, no patients reported any Adverse Reaction as well as no drug to drug interaction was observed with supplemental treatment with Aayudh Advance. Conclusion The Aayudh Advance was found safe as well as more effective in terms of reduction of viral load. % recovery was more in Treatment arm as compared to Control arm in mild symptomatic COVID-19 patients.
Background: The coronavirus pandemic which had its origin in the Wuhan China has been spreading across the globe with far reaching complications and a variable clinical course. A variation of the laboratory parameters during the disease course remains a constant parameter to monitor the disease course and progression. Since the laboratory parameters are standardized globally, these may also act as uniform guidelines for the patients monitoring and treatment. Aims and Objectives: The aim of the study was to serial charting of the laboratory parameters in the recovered and expired patients of COVID-19 and to determine an associated prognostic significance. Materials and Methods: A retrospective observational study from the laboratory and medical records was conducted on the patients admitted from March 17, 2020, to May 31, 2020, at the tertiary care center dedicated to the treatment of RT-PCR confirmed COVID-19 positive patients. Results: The group of parameters showing a poor prognosis include a rising WBC count, high neutrophilic percentage, low lymphocyte percentage (<10) an NLR > 15, low lymphocyte monocyte ratio < 3, rising blood urea nitrogen, serum creatinine levels, and serum electrolyte levels. The liver function tests variation reflecting a poor metabolic activity of the liver, namely, a low serum albumin and albumin globulin ratio, rising SGOT levels, and total bilirubin levels. A highly significant variation in the acute phase reactants showing an exponential rise such as the serum lactate dehydrogenase levels, serum ferritin, fibrinogen, C-reactive protein, and IL 6 levels an increased level of D Dimer (>3) and a prolongation of the APTT. Conclusion: The variation of the laboratory parameters acts as a fair marker for the disease progression. Since the disease shows a variable progression with a sudden worsening of the clinical symptoms, a comprehensive monitoring of the laboratory parameters serves to diagnose and treat the disease progression.
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