The study will be conducted in non-oncological female patients older than 50 years who have received the first dose of a COVID vaccination, or who have received the full vaccination within 8 weeks prior to the first planned blood collection. MedDRA version: 23.1 Level: PT Classification code 10084457 Term: COVID-19 immunisation System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Product Name: Raloxifene
Product Code: [Raloxifene]
Pharmaceutical Form: Tablet
INN or Proposed INN: RALOXIFENE CLORIDRATO
CAS Number: 84449-90-1
Current Sponsor code: raloxifene cloridrato
Concentrat
Sponsors
DOMPé FARMACEUTICI S.P.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Females Age > 50 years old • Patients who are under Raloxifene therapy as a prevention strategy or treatment of osteoporosis OR • Subjects who are taking alendronate as a prevention strategy for osteoporosis OR • Subjects who are taking Vit. D and Calcium as a prevention approach for osteoporosis OR • Subjects who are not receiving any osteoporosis preventive treatment or treatment • AND Who have received the first dose of a COVID vaccination, or who have received the full vaccination within 8 weeks prior to the first planned blood collection. All approved COVID vaccines are accepted. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: • Subjects who are SARS-CoV-2 positive • Subjects who have received the complete COVID vaccination more than 8 weeks prior to the first planned blood collection • Immunosuppressive or immunodeficient state, including human immunodeficiency virus (HIV) infection, asplenia, and recurrent severe infections • Subjects who have received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to the first planned blood collection (for corticosteroids =20 milligrams (mg)/day of prednisone equivalent) • Subjects who have received systemic immunoglobulins or blood products within 3 months prior to the first planned blood collection • Subjects who have received chemotherapy, radiation therapy or have undergone surgical intervention for cancer in the last 5 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to verify if Raloxifene treatment is able to stimulate the immunization against Sars-CoV-2 compared to other osteoporosis treatments/prevention strategies.;Secondary Objective: The Secondary objective is to evaluate if Raloxifene is able to boost COVID-19 vaccine’s efficacy by comparing the number of Sars-CoV-2 cases in the different groups after vaccination.;Primary end point(s): Quantification of SARS-CoV-2 Specific Neutralizing Antibody (nAb) and S protein-specific Binding Antibody (bAb) levels in patients’ blood serum and measurement of GMTs (geometric mean titers) and GMFRs (geometric mean fold rises) in SARS-CoV-2 Specific Neutralizing Antibody (nAb) and S protein-specific Binding Antibody (bAb) at the different timepoints;Timepoint(s) of evaluation of this end point: Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Proportion of participants tested positive for Sars-CoV-2 in the period from complete COVID vaccination to the end of the study (week 16 after complete vaccination) in the different groups;Timepoint(s) of evaluation of this end point: NA | — |
Countries
Italy
Contacts
Public ContactFlavio Mantelli
Dompé farmaceutici S.p.A.
Outcome results
None listed