treatment with conestat alfa in addition to standarf of care

Standard of care treatment established at the centers

Coronavirus Infections

Conestat alfa (8400 Units (U) followed by 4200 U every 8 hours, 9 administrations in total) will be administered as a slow intravenous injection (5-10 minutes) over a 72 hour period.

Conestat alfa

University Hospital Basel, Division of Internal Medicine

Conestat Alfa in the Prevention of Severe SARS-CoV-2 Infection in Hospitalized Patients With COVID-19

Recombinant Human C1 Esterase Inhibitor (Conestat Alfa) in the Prevention of Severe SARS-CoV-2 Infection in Hospitalized Patients With COVID-19: a Randomized, Parallel-group, Open-label, Multi-center Pilot Trial (PROTECT-COVID-19).

Disease severity on the 7-point Ordinal World Health Organization (WHO) scale (for the current study, score 0 will be omitted and score 6 and 7 will be combined). The ordinal scale measures illness severity over time. This endpoint has been suggested by WHO for clinical trials in patients with COVID-19.

Time to clinical improvement (time from randomisation to an improvement of two points on the seven-category WHO ordinal scale or live discharge from hospital, whichever came first)

Proportion of participants alive and not having required invasive or non-invasive ventilation

Proportion of subjects with an ALI (defined by PaO2/FiO2 ratio of <300mmHg)

Proportion of participants progressing to mechanical ventilation

Proportion of participants requiring ICU treatment

Time to virological clearance of SARS-CoV-2 by PCR from upper or lower respiratory tract samples

Proportion of patients receiving additional anti-inflammatory treatment such as tocilizumab or immunoglobulins

Time to defervescence (temperature <38.0°C)

Time to clinical improvement (defervescence, normalization of oxygen saturation (>93%) and respiratory rate)

Peak serum concentration of conestat alfa will be measured

Change in pharmacodynamics of conestat alfa (C1-inhibitor (CI-INH) concentration)

University Hospital, Basel, Switzerland

Pharming Technologies B.V.

Randomized, open-label, parallel-group, controlled, multi-center clinical trial

A respresentative population of 275 Liberian children with SAM and admitted to a CMAM/IMAM program supported by Action Against Hunger (75 of which have a MUAC < 115, 75 of which have a WHZ < -3 and 75 of which have both a MUAC < 115 mm and a WHZ < -3).

A respresentative population of 275 Burkinabé children with SAM and admitted to a CMAM/IMAM program supported by Action Against Hunger (75 of which have a MUAC < 115, 75 of which have a WHZ < -3 and 75 of which have both a MUAC < 115 mm and a WHZ < -3).

A respresentative population of 275 Bangladeshi children with SAM and admitted to a CMAM/IMAM program supported by Action Against Hunger (75 of which have a MUAC < 115, 75 of which have a WHZ < -3 and 75 of which have both a MUAC < 115 mm and a WHZ < -3).

Severe Acute Malnutrition

Action Against Hunger, Bangladesh

Action Contre la Faim, Burkina Faso

Action Against Hunger, Liberia

Biomedical Investigations for Optimized Diagnosis and Monitoring of Severe Acute Malnutrition (SAM): Elucidating the Heterogeneous Diagnosis of SAM by Current Anthropometric Criteria and Moving Beyond

OptiDiag: Biomedical Investigations for Optimized Diagnosis and Monitoring of Severe Acute Malnutrition (SAM): Elucidating the Heterogeneous Diagnosis of SAM by Current Anthropometric Criteria and Moving Beyond

Describe and compare the different types of SAM anthropometric diagnoses based on circulating leptin.

Describe and compare the different types of SAM anthropometric diagnoses based on Stable Isotope Analysis (SIA)

Describe and compare the different types of SAM anthropometric diagnoses based on the severity of clinical signs at admission; these include: dehydration, visible signs of wasting, pulse, signs of micronutrient deficiency, acute resipiratory infections, respiratory rate, temperature, dermatosis and hair changes and diarrhea.

Describe and compare the different types of SAM anthropometric diagnoses based on micronutrient status.

Describe and compare the different types of SAM anthropometric diagnoses based on bioelectric impedance (BI).

Describe and compare the different types of SAM anthropometric diagnoses based on the caretaker's perception of the patient's health and nutritional status.

Describe and compare the different types of SAM anthropometric diagnoses based on the history of lipid and protein catabolism (δ13C and δ15N isotopes in hair) reversed throughout nutritional rehabilitation.

Describe and compare the different types of SAM anthropometric diagnoses based on the severity of clinical signs for dehydration at admission and the development of clinical signs of dehydration during treatment.

Describe and compare the different types of SAM anthropometric diagnoses based on the severity of clinical signs of visible wasting at admission and the development of clinical signs of visible wasting during treatment.

Describe and compare the different types of SAM anthropometric diagnoses based on the severity of abnormal pulse at admission and the development of abnormal pulse during treatment.

Describe and compare the different types of SAM anthropometric diagnoses based on the severity of clinical signs of micronutrient deficency at admission and the development of clinical signs of micronutrient deficency during treatment.

Describe and compare the different types of SAM anthropometric diagnoses based on the severity of clinical signs of acute respiratory infection at admission and the development of clinical signs of acute respiratory infection during treatment.

Describe and compare the different types of SAM anthropometric diagnoses based on the severity of abnormal respiratory rate at admission and the development of clinical signs of abnormal respiratory rate during treatment.

Describe and compare the different types of SAM anthropometric diagnoses based on the severity of abnormal temperature at admission and the development of clinical signs of abnormal temperature during treatment.

Describe and compare the different types of SAM anthropometric diagnoses based on the severity of clinical signs of dermatosis at admission and the development of clinical signs of dermatosis during treatment.

Describe and compare the different types of SAM anthropometric diagnoses based on the severity of clinical signs of hair change (color and consistency) linked to acute malnutrition at admission and the development of clinical signs of of hair change (color and consistency) during treatment.

Describe and compare the different types of SAM anthropometric diagnoses based on the severity of diarrhea at admission and the development of diarrhea during treatment.

Describe and compare the different types of SAM anthropometric diagnoses based on negative and positive treatment outcomes; these include: discharged from program as recovered [mid-upper arm circumference (MUAC) ≥ 125 and weight-for-height Z-score (WHZ) ≥ -2], defaulted from program (caretaker confirmation of unwillingness to participate), death, transfer to an in-patient facility (developement of medical complications as per national protocol, loss of or static weight), transfer to another out-patient facility outside of the program catchment area and facility and non-response to treatment (cure criteria unattained before maximum treatment duration).

Describe and compare the different types of SAM anthropometric diagnoses based on early weight gain.

Describe and compare the different types of SAM anthropometric diagnoses based on circulating leptin

Describe and compare the different types of SAM anthropometric diagnoses based on bioelectric impedance.

Measures of household wealth reflected by durable assets, source of water supply, sanitation favility, type of floor material, type of cooking fuel, transportation, livestock, homestead or land area, bank account, number of family members per sleeping room.

The HFIAS is composed of a set of nine questions that have been used in several countries and appear to distinguish food insecure from food secure households across different cultural contexts.

Individual dietary diversity scores (IDDS) validated for age/sex groups.

Action Contre la Faim

Duke University

University Ghent

AgroParisTech

University College, London

Humanitarian Innovation Fund

European Commission's Directorate-General for European Civil Protection and Humanitarian Aid Operations

Subjects will receive a 15 mcg/kg bolus of nicardipine as needed followed by an infusion initiated at 5 mg/hr. Nicardipine may be titrated every 5 minutes, increasing 5 mg/hr and administering 15 mcg/kg bolus every minute to a maximum dose of 15 mg/hr. If systolic blood pressure (SBP) is not maintained < 140 mmHg 5 minutes after achieving the maximum dose of nicardipine, medication "failure" will be declared and rescue drug (medication to be determined per anesthesiologist discretion) will be administered. Infusions may be titrated down if SBP decreases below 90 mmHg.

Subjects will receive a 0.5 mg/kg bolus of esmolol as needed followed by an infusion initiated at 50 mcg/kg/min. Esmolol may be titrated every 5 minutes, increasing 50 mcg/kg/min and administering 0.5 mg/kg bolus every minute to a maximum dose of 200 mcg/kg/min. If SBP is not maintained < 140 mmHg 5 minutes after achieving the maximum dose of esmolol, medication "failure" will be declared and rescue drug (medication to be determined per anesthesiologist discretion) will be administered. Infusions may be titrated down if SBP decreases below 90 mmHg.

Subjects will receive a 15 mcg/kg bolus of nicardipine as needed followed by an infusion initiated at 5 mg/hr. Nicardipine may be titrated every 5 minutes, increasing 5 mg/hr and administering 15 mcg/kg bolus every minute to a maximum dose of 15 mg/hr. If SBP is not maintained < 140 mmHg 5 minutes after achieving the maximum dose of nicardipine, medication "failure" will be declared and rescue drug (medication to be determined per anesthesiologist discretion) will be administered. Infusions may be titrated down if SBP decreases below 90 mmHg.

Nicardipine

Esmolol

Total

Sex: Female, Male

Region of Enrollment

Failure of Drug to Control Systolic Blood Pressure (SBP) < 140 mmHg

Overall Study

John F. Bebawy, MD, Principal Investigator

Brain Tumors

Northwestern Memorial Hospital

Nicardipine vs Esmolol Craniotomy Emergence

Nicardipine Versus Esmolol for Management of Emergence Hypertension After Craniotomy

John Bebawy

Assistant Professor of Anesthesiology & Neurological Surgery

Northwestern University

Saline starting before induction till entry to abdominal cavity

Remifentanil starting before induction till entry to abdominal cavity

Pre-Eclampsia

Hypertension, Pregnancy-Induced

Pregnancy Complications

1 microg/kg iv bolus before induction followed by 0.5 microg/kg/min infusion

Remifentanil

same volume iv bolus before induction followed by same volume infusion

esterase/ödem

Conestat Alfa in the Prevention of Severe SARS-CoV-2 Infection in Hospitalized Patients With COVID-19

Biomedical Investigations for Optimized Diagnosis and Monitoring of Severe Acute Malnutrition (SAM): Elucidating the Heterogeneous Diagnosis of SAM by Current Anthropometric Criteria and Moving Beyond

Nicardipine vs Esmolol Craniotomy Emergence

Remifentanil for General Anesthesia in Preeclamptics

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