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Conestat alfaWiki

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Correlated Drug Terms (1)

Name (Synonyms) Correlation
drug660 Imaging by thoracic scanner Wiki 1.00

Correlated MeSH Terms (4)

Name (Synonyms) Correlation
D003141 Communicable Diseases NIH 0.10
D007239 Infection NIH 0.07
D045169 Severe Acute Respiratory Syndrome NIH 0.06
D018352 Coronavirus Infections NIH 0.05

Correlated HPO Terms (0)

Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials

1 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).

The aim of this study is to analyze if administration of conestat alfa for 72 hours in addition to standard of care (SOC) in patients hospitalized with non-critical SARS-CoV-2 pneumonia (WHO Ordinal Scale Score 3 or 4) reduces the risk of disease progression to Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome (ARDS).

NCT04414631 Coronavirus Infections Drug: Conestat alfa
MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

Primary Outcomes

Description: 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.

Measure: Disease severity

Time: on day 7

Secondary Outcomes

Description: 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)

Measure: Time to clinical improvement

Time: within 14 days after enrolment

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

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

Time: at 14 days after enrolment

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

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

Time: within 14 days after enrolment

Other Outcomes

Description: Changes in the ordinal WHO scale

Measure: Changes in the ordinal WHO scale

Time: from baseline over 14 days

Description: Length of hospital stay in survivors

Measure: Length of hospital stay in survivors

Time: until day 28

Description: Proportion of participants progressing to mechanical ventilation

Measure: Proportion of participants progressing to mechanical ventilation

Time: on day 7 and day 14

Description: Proportion of participants requiring ICU treatment

Measure: Proportion of participants requiring ICU treatment

Time: on day 7 and 14

Description: Length of ICU stay

Measure: Length of ICU stay

Time: until day 28

Description: 28 Ventilator-free days

Measure: 28 Ventilator-free days

Time: until day 28

Description: All-cause mortality

Measure: All-cause mortality

Time: time from randomisation to death within four weeks

Description: Changes in biomarker level CRP

Measure: Changes in biomarker level CRP (mg/l)

Time: until day 14

Description: Changes in biomarker level LDH

Measure: Changes in biomarker level LDH (U/l)

Time: until day 14

Description: Changes in biomarker level D-Dimer

Measure: Changes in biomarker level D- Dimer (yg/ml)

Time: until day 14

Description: Changes in biomarker level Ferritin

Measure: Changes in biomarker level Ferritin (ng/ml)

Time: until day 14

Description: Changes in biomarker level IL-6

Measure: Changes in biomarker level Interleukin 6 (IL- 6) (pg/ml)

Time: until day 14

Description: Changes in lymphocyte count

Measure: Changes in lymphocyte count (cells per microliter of blood)

Time: until day 14

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

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

Time: time from enrolment to first of 2 negative assays at least 12 hours apart

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

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

Time: within 14 days

Description: Time to defervescence (temperature <38.0°C)

Measure: Time to defervescence (temperature <38.0°C)

Time: sustained for at least 48 hours

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

Measure: Time to clinical improvement (defervescence, normalization of oxygen saturation (>93%) and respiratory rate) until day 28

Time: until day 28

Description: Duration of supplemental oxygen

Measure: Duration of supplemental oxygen

Time: until day 28

Description: Peak serum concentration of conestat alfa will be measured

Measure: Change in pharmacokinetics of conestat alfa

Time: at baseline, day 1, day 3, day 7, day 10 (during admission) and day 14 (1/- 2days) or discharge date

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

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

Time: at baseline, day 1, day 3, day 7, day 10 (during admission) and day 14 (1/- 2days) or discharge date

No related HPO nodes (Using clinical trials)