Conducting a phase III clinical trial in children during the COVID- 19 pandemic: Experience and lessons learnt from a clinical research facility of Nepal.

Clinical trials in humans are vital to test safety and efficacy of new interventions and are accompanied with the complexity of related regulatory guidelines, stringent time frame and financial burden particularly when participants are children. Conducting clinical trials in low and middle income countries, where 90% of global diseases occur, increases the complexity as resources, infrastructures, and experience related to clinical trials may be limited in some countries. During the COVID-19 pandemic, due to multiple infection control measures such as social distancing, lock-down of the societies, and increased work load of hospital workers, conducting clinical trials seemed very challenging. Related guidelines and recommendations on clinical trials required updates to adapt the situation for ongoing clinical trials to be continued and new clinical trials to be initiated. In this review report, we described the lessons learnt through our experiences, challenges we faced, and the mitigation measures implemented as a response while conducting a phase III clinical trial on a non-COVID-19 vaccine at a government children's hospital during the COVID-19 pandemic. We hope this report will contribute in lowering the obstacles to allow the successful completion of future studies, in countries where people live with the burden of vaccine-preventable diseases.

Clinicolaboratory Profile and Treatment Outcome Within Ninety Days After Discharge During Second Wave of Pediatric COVID-19.

BACKGROUND: The second wave of COVID-19 pandemic hit all age groups with different presentations and outcomes. This study aimed to explore the clinical characteristics, investigational findings, hospital outcomes along with a ninety days telephonic follow-up of COVID-19 infection in children. METHODS: A longitudinal descriptive study among COVID-19 RT-PCR positive hospital-admitted children was conducted during the second wave of the pandemic from 15 Mar 2021 to 15 Oct 2021 at Kanti Children's Hospital. Demographics, clinical characteristics, oxygen saturation, comorbidities, need of oxygen, need of ventilator, laboratory investigations, admission to intensive care unit, duration of hospital stay and patient's outcome (improved and discharged or death) were recorded. A follow up at ninety days from discharge was also done via telephonic call to inquire for any illness and hospital admission. RESULTS: Among the 156 admitted children, males and females were 54.5% and 45.5% with a median age of 15 months and Inter quartile range (IQR) of 63. Thirty-six (23.1%) were underweight and 31 (19.9%) had comorbidities. The most common presenting symptoms were fever 115 (73.7%), cough 50 (32.1%) and vomiting 38 (24.4%). The median (IQR) length of hospital stay was 15 (range of 11-20) days. Oxygen use was seen among 35 (22.4%) cases and 36 (23.1%) cases were admitted to the ICU. Ventilator was required for 7 (4.5%) cases. The number of deaths was 9 (5.8%) during hospital stay. After discharge from the hospital during the ninety days follow-up, 117 children had no health problems while 42 reported having some health problems and 5 died after discharge. CONCLUSIONS: In the second wave of the pandemic, only symptomatic children were admitted. Respiratory and gastrointestinal symptoms were common among the admitted cases. The majority of admitted cases had a good outcome and had no other health problems attributable to COVID-19 till ninety days of follow-up.