Prospective study to evaluate the effects of Raloxifene therapy on SARS-CoV-2 immunity after COVID-19 vaccinatio

Phase 1

• Conditions: 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: 23.1Level: PTClassification code 10084457Term: COVID-19 immunisationSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2021-002476-39-IT
• Lead Sponsor: DOMPé FARMACEUTICI S.P.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-30
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 40

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

• 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified