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

• Register: ClinicalTrials.gov
• Last refreshed on: 15 November 2021
• Main ID: NCT04414631
• Date of registration: 19/05/2020
• Prospective Registration: Yes
• Primary sponsor: University Hospital, Basel, Switzerland
• Public title: Conestat Alfa in the Prevention of Severe SARS-CoV-2 Infection in Hospitalized Patients With COVID-19
• Scientific title: 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).
• Date of first enrolment: August 6, 2020
• Target sample size: 80
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT04414631
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Brazil, Mexico, Switzerland

Contacts

• Name: Michael Osthoff, PD Dr. med.
• Affiliation: University Hospital Basel, Division of Internal Medicine

Key inclusion & exclusion criteria

Inclusion Criteria:

- Informed Consent as documented by signature

- admitted to the hospital because of confirmed (by a positive SARS-CoV-2 PCR result)
COVID-19 infection

- evidence of pulmonary involvement on CT scan or X-ray of the chest (e.g. ground glass
opacities)

- symptom onset within the previous 10 days OR shortness of breath within the previous 5
days. Symptoms include fever or one respiratory symptom (patients presenting later may
have already progressed to an inflammatory state that is potentially not amenable to
C1INH treatment). Respiratory symptoms include cough, sore throat, hemoptysis,
shortness of breath, runny nose, or chest pain.

- expected to remain an inpatient over the next three calender days from time of
enrolment

- at least one additional risk factor for progression to mechanical ventilation: 1)
arterial hypertension, 2) >50 years, 3) obesity (BMI>30.0 kg/m2), 4) cardiovascular
disease, 5) chronic pulmonary disease, 7) chronic renal disease, 6) C-reactive protein
of >35mg/L, 7) oxygen saturation at rest in ambient air of <94%. Cardiovascular
disease includes a history of coronary artery disease, cerebrovascular disease,
peripheral artery disease, rheumatic heart disease, congenital heart disease and of
recent (< 3 months) deep vein thrombosis or pulmonary embolism. Chronic pulmonary
disease includes a history of chronic obstructive pulmonary disease, asthma,
occupational lung disease, interstitial lung disease or of pulmonary hypertension.
Chronic renal disease is defined as a history of an estimated glomerular filtration
rate (according to the Chronic Kidney Disease Epidemiology Collaboration equation) <
60ml/min/1.73 m2 for at least three months.

Exclusion Criteria:

- Contraindications to the class of drugs under study (C1 esterase inhibitor), e.g.
known hypersensitivity or allergy to class of drugs or the investigational product

- Treatment with tocilizumab or another Il-6R or Il-6 inhibitor before enrolment

- History or suspicion of allergy to rabbits

- Women who are pregnant or breast feeding

- Active or planned treatment with any other complement inhibitor

- Liver cirrhosis (any Child-Pugh score)

- Incapacity or inability to provide informed consent

- Currently admitted to an ICU or expected admission within the next 24 hours

- Currently receiving invasive or non-invasive ventilation (with the exception of
high-flow oxygen therapy).

- In the opinion of the treating time, death is deemed to be imminent and inevitable
within the next 24 hours

- Participation in another study with investigational drug within the 30 days preceding
and during the present study with the following exemptions: 1) participation in
COVID-19 drug trials started at least 48 hours before admission (e.g. postexposure
prophylaxis with hydroxychloroquine) and 2) participation in COVID-19 drug trials
during ICU admission

- Previous enrolment into the current study

- Enrolment of the investigator, his/her family members, employees and other dependent
persons

- Any uncontrolled or significant concurrent illness that would put the patient at a
greater risk or limit compliance with the study requirements



Age minimum: 18 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Coronavirus Infections

Intervention(s)

Drug: Conestat alfa

Primary Outcome(s)

Disease severity [Time Frame: on day 7]

Secondary Outcome(s)

Proportion of participants alive and not having required invasive or non-invasive ventilation [Time Frame: at 14 days after enrolment]

Time to clinical improvement [Time Frame: within 14 days after enrolment]

Proportion of subjects with an ALI (defined by PaO2/FiO2 ratio of <300mmHg) [Time Frame: within 14 days after enrolment]

Secondary ID(s)

2020-01252; me20Osthoff3

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Pharming Technologies B.V.