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Presence of Nepal in global clinical trials has been visibly negligible despite the history of conducting large scaled randomized controlled trial on Hepatitis E vaccine decades ago. Majority of the problem is attributed to the lack of collaborative work, financial and human resource constrains. COVID-19 pandemics seems to have triggered urgency among the authorities of Nepal leading to a substantial increase in the number of clinical trials in collaboration with national and international organizations/institutions. Immediately after detection of the first COVID-19 case on 13 January 2020, the Ethical Review Board (ERB) of NHRC received several research proposals, subsequently leading to the approval of the first clinical trial for COVID-19 on 01 July 2020 to investigate potential of traditional Ayurveda based medicine for COVID treatment. Soon, number of other clinical trial proposals received approval and implemented in the country, however budgetary allocation from the Government of Nepal (GON) was prioritized for COVID-19 outrage management and vaccination coverage only. Collaborations with various international institutions played a significant role in the successful implementation of large-scale clinical trials in the country and further laid the path for future. In this review paper we present the recent developments in clinical trials in Nepal, budgetary allocation from the government and the mechanisms in place for regulation of clinical research in the country along with challenges and way forward.

Like the world over, Nepal was also hard hit by the second wave of COVID-19. We audited the clinical care provided to COVID-19 patients admitted from April to June 2021 in a tertiary care hospital of Nepal. This was a cohort study using routinely collected hospital data. There were 620 patients, and most (458, 74%) had severe illness. The majority (600, 97%) of the patients were eligible for admission as per national guidelines. Laboratory tests helping to predict the outcome of COVID-19, such as D-dimer and C-reactive protein, were missing in about 25% of patients. Nearly all (>95%) patients with severe disease received corticosteroids, anticoagulants and oxygen. The use of remdesivir was low (22%). About 70% of the patients received antibiotics. Hospital exit outcomes of most (>95%) patients with mild and moderate illness were favorable (alive and discharged). Among patients with severe illness, about 25% died and 4% were critically ill, needing further referral. This is the first study from Nepal to audit and document COVID-19 clinical care provision in a tertiary care hospital, thus filling the evidence gap in this area from resource-limited settings. Adherence to admission guidelines was excellent. Laboratory testing, access to essential drugs and data management needs to be improved.

The COVID-19 pandemic and public health response to the pandemic has caused huge setbacks in the management of other infectious diseases. In the present study, we aimed to (i) assess the trends in numbers of samples from patients with influenza-like illness and severe acute respiratory syndrome tested for influenza and the number and proportion of cases detected from 2015–2021 and (ii) examine if there were changes during the COVID-19 period (2020–2021) compared to the pre-COVID-19 period (2015–2019) in three states of India. The median (IQR) number of samples tested per month during the pre-COVID-19 period was 653 (395–1245), compared to 27 (11–98) during the COVID-19 period (p value < 0.001). The median (IQR) number of influenza cases detected per month during the pre-COVID-19 period was 190 (113–372), compared to 29 (27–30) during the COVID-19 period (p value < 0.001). Interrupted time series analysis (adjusting for seasonality and testing charges) confirmed a significant reduction in the total number of samples tested and influenza cases detected during the COVID-19 period. However, there was no change in the influenza positivity rate between pre-COVID-19 (29%) and COVID-19 (30%) period. These findings suggest that COVID-19-related disruptions, poor health-seeking behavior, and overburdened health systems might have led to a reduction in reported influenza cases rather than a true reduction in disease transmission.

WHO recommends surveillance for COVID-19 among travelers at Points of Entry (POE) to countries. At 13 selected POE at the Nepal-India border, between March 2021 and July 2021, we describe the screening, testing, diagnosis and isolation practices of COVID-19 amongst travelers. Those who stayed in India or elsewhere for > one day and those who did not have a negative RT-PCR result within the last 72 h of travel were tested for COVID-19 with rapid antigen diagnostic tests. Daily surveillance reports maintained at POE were used for analysis. Of 337,338 travelers screened, 69,886 (21%) were tested and 3907 (6%) were diagnosed with COVID-19. The proportions tested averaged 15% during April-May when screened numbers were high and increased to 35% in July when screened numbers had decreased. The proportions diagnosed positive peaked at 10% in April-May, but decreased to below 1% in June and July. Testing coverage varied from 0–99% in the different POE. Most COVID-19 cases were Nepalese, male,

In Nepal, case investigation and contact tracing (CICT) was adopted as an important public health measure to reduce COVID-19 transmission. In this study, we assessed the performance of CICT in Madhesh Province of Nepal against national benchmarks, using routine programmatic data reported by district CICT teams. Between May and July 2021, 17,943 COVID-19 cases were declared in the province, among which case investigation was performed for 30% (95% CI: 29.6–31.0%) within 24 h (against 80% benchmark). As a result of case investigations, 6067 contacts were identified (3 contacts per 10 cases), of which 40% were traced and tested for SARS-CoV-2 infection (against 100% benchmark). About 60% of the contacts tested positive. At most 14% (95% CI: 13.1% to 14.9%) of traced contacts underwent a 14-day follow-up assessment (against 100% benchmark). We found the performance of the CICT program in Madhesh Province to be sub-optimal and call for corrective measures to strengthen CICT in the province and the country at large. Similar studies with wider geographical scope and longer time frames are needed to identify and address deficiencies in data recording and reporting systems for COVID-19, in low- and middle-income countries like Nepal and others.