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

DOMPé FARMACEUTICI S.P.A.0 个研究点目标入组 40 人开始时间: 2021年8月30日最近更新: 2022年3月14日

适应症

试验速览

暂无简介。

•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
•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

•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

发起方