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Background and Aims: A major limitation to providing oxygen therapy by high flow nasal oxygen (HFNO) delivery devices is its availability and therefore as an alternative many clinicians use a standard non rebreathing face mask (NRBM) in order to oxygenate their patients where low-flow nasal oxygen or simple facemask oxygen is not providing adequate respiratory support to achieve the target peripheral oxygen saturation (SpO2). We aimed to determine the clinical effectiveness of HFNO versus NRBM in terms of improving patient outcome among patients admitted to our intensive care unit (ICU) during coronavirus disease-2019 (COVID-19) outbreak. Methods: In this prospective open labelled study, 122 COVID-19 patients presenting with acute hypoxaemic respiratory failure (AHRF) were randomised to receive either HFNO or NRBM to achieve the target SpO2. The primary clinical outcome measured was device failure rate and secondary outcome was all-cause 28-day mortality rate. Results: The device failure rate was significantly higher in HFNO group (39% versus 21%, P = 0.030). Oxygen support with NRBM resulted in a reduced all mortality rate over HFNO (26.2% versus 45%) but the mortality rate after treatment failure in either group (HFNO or NRBM) remained high (91% versus 92%). Conclusion: Oxygen support with NRBM results in both reduced device failure rate and higher survival among patients of COVID-19 with AHRF.
ABSTRACT
PURPOSE: A large number of new molecular or virology laboratories have been established to increase the testing capacity for SARS-CoV-2. Due to heavy workload, there is delay in testing of samples. In order to avoid the negative effect of delayed testing on RTPCR results guidelines are issued from WHO and CDC to transport samples in cold chain. However, in pandemic situations the recommended guidelines for transport and storage conditions are often compromised. This study was conducted to evaluate the effect of sample storage conditions at different temperatures on the results of RT PCR test. METHODS: Total 275 samples were included in this study, among these 126 samples tested positive and 149 samples tested negative. All samples were aliquoted into two and the aliquotes stored in duplicate at 4 â°C and room temperature. All aliquots stored at both the temperatures were tested by RTPCR every 24 hours up to 5 days. RESULTS: Diagnostic accuracy decreased from day1 to day 5 at both the storage temperatures i,e 4 â°C and room temperature in comparison to the initial day results. Positivity decreased on an average of 9.02% at 4 â°C and at 9.27% at room temperature per day. Among total 126 positive samples on an average false negative and failure of internal control at 4 â°C and room temperature was 8.86%, 8.22% and 3.64%, and 4.12%, respectively. All the samples with CT value â< â30 remained positive at both temperatures up to 5 days. Few samples with >30 CT value showed variable results i.e. positive, negative or internal control failure from day 1 (2nd day after sample collection) onwards. CONCLUSIONS: There was no significant difference between RT PCR results of samples stored at 4 â°C and room temperature up to 5 days of collection. However internal control failure was more in samples stored at room temperature. Therefore, samples received without cold chain also may be processed by RTPCR and should not be rejected.
Subject(s)
COVID-19 , SARS-CoV-2 , COVID-19/diagnosis , COVID-19 Testing , Humans , Pandemics , Reverse Transcriptase Polymerase Chain Reaction , SARS-CoV-2/genetics , Specimen Handling/methods , TemperatureABSTRACT
ObjectivesConvalescent 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. DesignOpen-label, parallel-arm, phase II, multicentre, randomized controlled trial. SettingThirty-nine public and private hospitals across India. ParticipantsHospitalized, moderately ill confirmed COVID-19 patients (PaO2/FiO2: 200-300 or respiratory rate > 24/min and SpO2 [≤] 93% on room air). InterventionParticipants 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 MeasureComposite of progression to severe disease (PaO2/FiO2< 100) or all-cause mortality at 28 days post-enrolment. ResultsBetween 22nd April to 14th 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]. InterpretationCP 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. Trial registrationThe trial was registered with Clinical Trial Registry of India (CTRI); CTRI/2020/04/024775.
