Table 2.
Study (Country) | Design | Primary Outcomes | Neurology-Pertinent Secondary Outcomes |
COVID-19: Pediatric Research Immune Network on SARS-CoV-2 and MIS-C (PRISM)Trial number: NCT 04588363 (United States) | • Study Design: Prospective observational multisite cohort• Population: Acute COVID-19 and/or MIS-C• Inclusion criteria: <21 years old• Exclusion criteria: none | • Proportion of patients with death, rehospitalization, or complication | • Neurologic sequelae up to 1-year postillness• Health-related quality of life up to 1-year postillness |
Global Consortium to Study Neurological dysfunction in COVID-19 (GCS-NeuroCOVID)Trial number: NCT 04379089 (Multinational) | • Study Design: Prospective observational multisite registry• Population: Acute COVID-19 and/or MIS-C• Inclusion criteria: <18 years old• Exclusion criteria: none | • Overall prevalence of neurological manifestations among hospitalized COVID-19 and/or MIS-C patients• Health-related quality of life 1-month postdischarge | • In-hospital, 30 and 90-day mortality• Discharge modified Rankin score |
Neurocognitive Impairment in Patients With COVID-19Trial number: NCT04359914 (Germany) | • Study Design: Observational case control study• Population: Cohorts of adults and children with (cases) and without (controls) SARS-CoV-2 infection• Inclusion criteria: Patients admitted to a hospital and SARS-CoV-2 confirmed (cases) or excluded (controls) within 48 h of admission• Exclusion criteria: none | • Incidence of delirium/neurocognitive impairment in adult and pediatric patients with COVID-19• Change in neuroaxonal injury biomarker levels in patients with COVID-19• Neurocognitive 3-months outcome in patients with COVID-19 | • 90-day modified Rankin scale |
CORONERVE:Neurological complications of COVID-19(United Kingdom) | • Study design: Multisite observational study• Population: Children with acute onset neurological syndrome including encephalitis, encephalopathy, meningitis, demyelination, myelitis, cerebrovascular, cerebellar, Guillain-Barre syndrome, etc. in eligible population• Inclusion criteria: Child 0–18 years of age with suspected or proven COVID-19 infection and acute neurological syndrome as above• Exclusion criteria: No evidence of active or recent COVID-19 Infection. | • To determine the demographic, clinical, laboratory and radiographic features of patients presenting with acute neurological syndromes during or within 6 weeks of virologically proven coronavirus infection | • Proportion receiving immune and associated therapies• Clinical outcomes of patients which each neurological syndrome relative to baseline features and treatments received |
NEPSycon-COVID: Assessment of Neurological, Epidemiological, Psychiatric and Psychosocial Consequences during the COVID-19 PandemicTrial number: CTRI/2020/08/027490 (India) | • Study design: Prospective observational study• Population: All neurological patients [1–70 years] visiting the neurological emergency with the following criteria.• Inclusion criteria:a. Patients of neurological disorders with previously described symptoms related to COVID-19 infection (e.g. stroke, acute encephalitis, seizure, Guillain-Barre syndrome, ADEM)b. Patients of neurological disorders precipitated or preceded by respiratory symptoms in the last 2–4 weeksc. Patients of neurological symptoms (not fitting the criteria of a/b) but found to have lymphopenia / thrombocytopenia /thrombotic states / elevated D-dimer levels• Exclusion criteria: neurological disorders of other etiology and lack of consent | • Death | • Proportions of patients with each neurological diagnosis in the group with neurological disease• Admission to critical (intensive/high dependency) care unit• Time to discharge from hospital• Functional outcome at discharge (or 30 days from admission, if still in hospital) |
Perinatal Covid-19 Infection, NO Pathway, and Minipuberty (miniNO-COVID)Trial number: NCT04952870 (France) | • Study Design: Single site prospective observational case-control study• Population: Newborn infants (24 to 41 weeks gestational age) or young infants (< 3 months)• Inclusion criteria:Group 1: Antenatal or perinatal COVID-19 infectionGroup 2: Severe cardiorespiratory diseases requiring inhaled NO treatmentGroup 3: Control group without perinatal COVID-19 infection and no inhaled NO treatment [matched]• Exclusion criteria: <24 weeks gestational age, severe brain lesions: bilateral/extensive periventricular leukomalacia, intracranial hemorrhage grade 3 or 4 | • The follicle stimulating hormone (FSH) plasma concentrations measured at the postnatal age of 3 months | • Rate of negative hearing and olfactive tests• Developmental scores (ASQ-3, ASQ-2E, Bayley III)• Time of mutual gaze interactions (vs noninteractive periods) measured by eye-tracking glasses (mother and children) at 9 months |
Brain imaging in baby studyTrial number: NCT04443179 (United Kingdom) | • Study Design: Prospective observational case control study• Population: Community sampling of eligible cohorts listed below• Inclusion criteria: Pregnant mothers with and without confirmed COVID-19; Infants with and without an immediate family history of Autism Spectrum, neurodevelopmental conditions; based in England, UK• Exclusion criteria: based on further screening• Note: This is not a COVID-19 specific study. COVID-19 cohort was added to an existing study. | • Neurodevelopmental outcomes of children at 3–4 years of age | |
CLoCk: Children & young people with Long Covid studyTrial number: ISRCTN34804192 (United Kingdom) | • Study design: A longitudinal cohort analytic study with online questionnaire (3, 6, 12 and 24 months post-COVID test)• Population: SARS-CoV-2 positives aged 11–17 years compared with age, sex and region matched SARS-CoV-2 test negative controls• Inclusion criteria: Those that have had a COVID-19 test between 01/09/2020 and 28/02/2021.• Exclusion criteria: None | • Physical symptoms: ISARIC Pediatric COVID-19 questions• Emotional and mental health: Strength and Difficulties Questionnaire• Quality of life/functioning: EQ-5D-Y• Fatigue: Chalder Fatigue Questionnaire• Wellbeing: Warwick Edinburgh Mental Wellbeing Scale (WEMWBS, short version)• Loneliness: adapted UCLA 4 items |
SARS-CoV-2, severe acute respiratory syndrome coronavirus-2; COVID-19, coronavirus disease 2019.