Adult paucisymptomatic COVID-19 patients MedDRA version: 20.0 Level: HLGT Classification code 10047438 Term: Viral infectious disorders System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: RALOXIFENE SANDOZ - 60 MG COMPRESSE RIVESTITE CON FILM 28 COMPRESSE IN BLISTER PVC/PE/PVDC/AL
Product Name: Raloxifene
Product Code: Raloxifene
Pharmaceutical Form: Capsule, hard
INN or P
Sponsors
DOMPE FARMACEUTICI S.P.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject autonomously provides informed consent prior to initiation of any study procedures; 2. Males and females > 40 years old at time of enrolment; 3. Understands and agrees to comply with planned study procedures, has the availability of an email address as well as an Internet connection at domicile location; 4. Agrees to the collection of nasopharyngeal swabs and venous blood samples per protocol; 5. Has laboratory-confirmed SARS-CoV-2 infection as determined by an approved molecular test (PCR) in Europe within 10 days at the screening time; 6. Patient paucisymptomatic who complains at the screening time at least one of the following symptoms mild to moderate: fever, dyspnea, headache, cough, dysgeusia, conjunctivitis, vomiting, diarrhea, anosmia, muscle or body aches or other symptoms which in the opinion of the Investigator are part of the COVID-19 clinical picture; 7. No need of supplemental oxygen therapy, mechanical ventilation; 8. Females of child-bearing potential and with an active sexual life must not wish to get pregnant within 30 days after the end of the study and must be using at least one of the following reliable methods of contraception: a) Hormonal contraception, systemic, implantable, transdermal, or injectable contraceptives for at least 2 months before the screening visit until 30 days after final visit b) A non-hormonal intrauterine device [IUD] or female condom with spermicide or contraceptive sponge with spermicide or diaphragm with spermicide or cervical cap with spermicide for at least 2 months before the screening visit until 30 days after final visit c) A male sexual partner who agrees to use a male condom with spermicide d) A sterile sexual partner Female participants of non-child-bearing potential or in post-menopausal status for at least 1 year will be admitted. For all female subjects, with child-bearing potential, pregnancy test result must be negative before first drug intake on T7 and T14. 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 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria are NOT eligible for inclusion in the study. 1. Being totally asymptomatic at the screening time; 2. Requires supplemental oxygen therapy or mechanical ventilation; 3. Being already under raloxifene or other SERM treatment for another medical condition at the time of randomization; 4. Being concurrently involved in another trial with IP or participation in any clinical trial with IP for 1 months before this study. The 1-month interval is calculated as the time between the last visit of the previous study and the first day of the present study (date of the informed consent signature); 5. Clinically significant abnormal physical findings which could interfere with the objectives of the study; 6. Diseases: a) history of stroke and/or venous thromboembolism; b) known moderate / severe renal impairment: Chronic Kidney Disease (CKD) stage 3 or higher; c) known liver disease (Child-Pugh Class A or higher); d) presence of known hypoalbuminemia; e) endometrial bleeding; f) signs or symptoms of endometrial cancer; 7. Autoimmune diseases receiving therapy at the time of randomization; 8. Risk of venous thrombosis or any condition/disease that could bring to an extended period of immobilization; 9. Ascertained or presumptive hypersensitivity to the active principles (raloxifene) and/or excipients or allergic reactions in general, which the Investigator considers may affect the outcome of the study; 10. Medications: in particular cholestyramine (or any ion exchange resin), medications used in treatment of early or advanced breast cancer (including adjuvant therapy), warfarin, any drug that cannot be co-administered with the experimental compound; 11. Pregnancy: a) positive or missing pregnancy test before first drug intake or day 1; b) pregnant or lactating women; 12. Women of childbearing potential and fertile men who does not agree to use at least one primary form of contraception for the duration of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of the effectiveness of therapy in reducing the proportion of subjects who still have viruses in the upper airways after 7 days of therapy; Evaluation of the effectiveness of therapy in reducing the proportion of subjects who requires supplemental oxygen therapy and/or mechanical ventilation within 14 days of starting therapy.;Secondary Objective: Evaluation of the effectiveness of therapy in reducing the proportion of subjects who still have viruses in the upper airways after 14 and 28 days of therapy; Evaluation of the effectiveness of therapy in reducing the proportion of subject patients who requires supplemental oxygen therapy and/or mechanical ventilation within 7 or 28 days of starting therapy; 7, 14 and 28 days drug safety and tolerability profile; Assessment of body temperature, blood and biochemical parameters between T0 and T28.;Primary end point(s): Virologic outcome. Proportion of participants with undetectable SARSCoV-2at PCR at day 7 after randomization. Clinical outcome. Proportion of participants who not requires supplemental oxygen therapy (NEWS <=2) and/or mechanical ventilation at day 14 after randomization. ;Timepoint(s) of evaluation of this end point: Virologic outcome: at day 7 after randomization. Clinical outcome: at day 14 after randomization. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? Proportion of participants with undetectable SARS-CoV-2 at PCR at day 14 after randomization at day 28 after randomization; ? Proportion of participants who does not require supplemental oxygen therapy (NEWS = 2) and/or mechanical ventilation at day 7 and 28 after randomization; ? Proportion of patients in each NEWS category at time 7, 14 and 28 after randomization; ? Mean value of NEWS category at time 7, 14 and 28 after randomization; ? Proportion of participants with any adverse event with grade = 2 according to CTCAE at day 7, 14 and 28 after randomization; ? Proportion of participants with any severe adverse events (grade = 3 according to CTCAE) at day 7, 14 and 28 after randomization; ? Proportion of hospitalized participants who at the beginning of the study were at domicile isolation at day 7, 14 and 28 after randomization; ? Proportion of participants admitted to intensive care at day 7, 14 and 28 after randomization; ? Proportion of survivors at day 7, 14 and 28 after randomization; ? Mean variation of value of the following biomarker parameters, from base line to day 7, 14, 21 and 28 after randomization: o Complete blood cell counts; o Hepatic function (ALT, AST and bilirubin); o Coagulation (PT, aPTT and INR); o Other markers including (D-dimer, CPK, LDH); ? Quality of life questionnaire 3 months after the randomization.;Timepoint(s) of evaluation of this end point: ?At day 7, 14 and 28 after randomization: -proportion of participants: in each NEWS category, with any adverse event, hospitalized participants who at the beginning of the study were at domicile isolation, admitted to intensive care, survivors -mean value of NEWS category ?3 months after the randomization: Quality of life questionnaire ?From base line to day 7, 14, 21 and 28 after randomization: Mean variation of value of biomarker parameters. ?At day 14 and 28 after randomization: proportion of participants with undetectable SARS-CoV-2 at PCR. ?At day 7 and 28 after | — |
Countries
France, Italy
Contacts
Public ContactFlavio Mantelli
Dompé farmaceutici S.p.A.
Outcome results
None listed