Register: ClinicalTrials.gov
Last refreshed on: 11 January 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: 120
Recruitment status: Recruiting
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
Switzerland
Contacts
Name: Michael Osthoff, PD Dr. med.
Address:
Telephone: +41 61 328 6828
Email: michael.osthoff@usb.ch
Affiliation:
Name: Michael Osthoff, PD Dr. med.
Address:
Telephone: +41 61 328 6828
Email: michael.osthoff@usb.ch
Affiliation:
Name: Michael Osthoff, PD Dr. med.
Address:
Telephone:
Email:
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, i.e. fever or one respiratory symptom
(patients presenting later may have already progressed to an inflammatory state that
is potentially not amenable to C1INH treatment) OR shortness of breath within the
previous 5 days
- 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%
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
- 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]
Proportion of subjects with an ALI (defined by PaO2/FiO2 ratio of <300mmHg) [Time Frame: within 14 days after enrolment]
Time to clinical improvement [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.
Ethics review
Results