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 The primary objective of National NCD monitoring survey (NNMS) was to generate national-level estimates of key NCD indicators identified in the national NCD monitoring framework. This paper describes survey study protocol and prevalence of risk factors among adults (18–69 years). Materials and methods NNMS was a national level cross-sectional survey conducted during 2017–18. The estimated sample size was 12,000 households from 600 primary sampling units. One adult (18–69 years) per household was selected using the World Health Organization-KISH grid. The study tools were adapted from WHO-STEPwise approach to NCD risk factor surveillance, IDSP-NCD risk factor survey and WHO-Global adult tobacco survey. Total of 8/10 indicators of adult NCD risk factors according to national NCD disease monitoring framework was studied. This survey for the first time estimated dietary intake of salt intake of population at a national level from spot urine samples. Results Total of 11139 households and 10659 adults completed the survey. Prevalence of tobacco and alcohol use was 32.8% (95% CI: 30.8–35.0) and 15.9% (95% CI: 14.2–17.7) respectively. More than one-third adults were physically inactive [41.3% (95% CI: 39.4–43.3)], majority [98.4% (95% CI: 97.8–98.8)] consumed less than 5 servings of fruits and / or vegetables per day and mean salt intake was 8 g/day (95% CI: 7.8–8.2). Proportion with raised blood pressure and raised blood glucose were 28.5% (95% CI: 27.0–30.1) and 9.3% (95% CI: 8.3–10.5) respectively. 12.8% (95% CI: 11.2–14.5) of adults (40–69 years) had ten-year CVD risk of ≥30% or with existing CVD. Conclusion NNMS was the first comprehensive national survey providing relevant data to assess India’s progress towards targets in National NCD monitoring framework and NCD Action Plan. Established methodology and findings from survey would contribute to plan future state-based surveys and also frame policies for prevention and control of NCDs.

Background The monitoring framework for evaluating health system response to noncommunicable diseases (NCDs) include indicators to assess availability of affordable basic technologies and essential medicines to treat them in both public and private primary care facilities. The Government of India launched the National Program for Prevention and Control of Cancer, Diabetes, Cardiovascular diseases and Stroke (NPCDCS) in 2010 to strengthen health systems. We assessed availability of trained human resources, essential medicines and technologies for diabetes, cardiovascular and chronic respiratory diseases as one of the components of the National Noncommunicable Disease Monitoring Survey (NNMS - 2017-18). Methods NNMS was a cross-sectional survey. Health facility survey component covered three public [Primary health centre (PHC), Community health centre (CHC) and District hospital (DH)] and one private primary in each of the 600 primary sampling units (PSUs) selected by stratified multistage random sampling to be nationally representative. Survey teams interviewed medical officers, laboratory technicians, and pharmacists using an adapted World Health Organization (WHO) – Service Availability and Readiness Assessment (SARA) tool on handhelds with Open Data Kit (ODK) technology. List of essential medicines and technology was according to WHO - Package of Essential Medicines and Technologies for NCDs (PEN) and NPCDCS guidelines for primary and secondary facilities, respectively. Availability was defined as reported to be generally available within facility premises. Results Total of 537 public and 512 private primary facilities, 386 CHCs and 334 DHs across India were covered. NPCDCS was being implemented in 72.8% of CHCs and 86.8% of DHs. All essential technologies and medicines available to manage three NCDs in primary care varied between 1.1% (95% CI; 0.3–3.3) in rural public to 9.0% (95% CI; 6.2–13.0) in urban private facilities. In NPCDCS implementing districts, 0.4% of CHCs and 14.5% of the DHs were fully equipped. DHs were well staffed, CHCs had deficits in physiotherapist and specialist positions, whereas PHCs reported shortage of nurse-midwives and health assistants. Training under NPCDCS was uniformly poor across all facilities. Conclusion Both private and public primary care facilities and public secondary facilities are currently not adequately prepared to comprehensively address the burden of NCDs in India.

BackgroundEpidemic diphtheria is still poorly understood and continues to challenge both developing and developed countries. In the backdrop of poor immunization coverage, non-existent adult boosters, weak case based surveillance and persistence of multiple foci, there is a heightened risk of re-emergence of the disease in epidemic forms in India. Investigating each outbreak to understand the epidemiology of the disease and its current status in the country is therefore necessary. Dhule a predominantly tribal and rural district in Northern Maharashtra has consistently recorded low vaccination coverages alongside sporaidic cases of diphtheria over the last years.MethodsThis study reports the findings of an onsite survey conducted to assess a recent outbreak of diphtheria in Dhule district and the response mounted to it. Secondary data regarding outbreak detection and response were obtained from the district surveillance office. Clinical data were extracted from hospital records of eleven lab confirmed cases including one death case. Frequency distributions were calculated for each identified clinical and non- clinical variable using Microsoft™ Excel® 2010.ResultsOur findings suggest a shift in the median age of disease to adolescents (10-15 years) without gender differences. Two cases (18%) reported disease despite immunization. Clinical symptoms included cough (82%), fever (73%), and throat congestion (64%). About 64% and 36% of the 11 confirmed cases presented with a well defined pseudomembrane and a tonsillar patch respectively. Drug resistance was observed in all three culture positive cases. One death occurred despite the administration of Anti-Diphtheric Serum in a partially immunized case (CFR 9%). Genotyping and toxigenicity of strain was not possible due to specimen contamination during transport as testing facilities were unavailable in the district.ConclusionsThe outbreak raises several concerns regarding the epidemiology of diphtheria in Dhule. The reason for shift in the median age despite consistently poor immunization coverage (below 50%) remains unclear. Concomitant efforts should now focus on improving and monitoring primary immunization and booster coverages across all age groups. Gradually introducing adult immunization at ten year intervals may become necessary to prevent future vulnerabilities. Laboratory networks for genotyping and toxigenicity testing are urgently mandated at district level given the endemicity of the disease in the surrounding region and its recent introduction in remote Dhule. Contingency funds with pre- agreements to obtain ADS and DT/Td vaccines at short notice and developing standard case management protocols at district level are necessary. Monitoring the disease, emerging strains and mutations, alongside drug resistance through robust and effective surveillance is a pragmatic way forward.

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