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 14 COMPRESSE IN BLISTER PVC/PE/PVDC/AL
Product Name: Raloxifene
Product Code: [Raloxifene]
Pharmaceutical Form: Capsule, hard
INN or
Sponsors
DOMPé FARMACEUTICI S.P.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject (or legally authorized representative) provides igormed consent prior to initiation of any study procedures; 2. Males and females >= 50 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 Italy within 7 days of randomization; 6. Complains since less than 7 days before positive result to swab, at least one of the following symptoms with mild to moderate intensity: fever, dyspnea, headache, cough, dysgeusia, conjunctivitis, vomiting, diarrhea, anosmia, muscle or body aches; 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. 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 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 135
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria are NOT eligible for inclusion in the study. 1. Being totally asymptomatic for less than 7 days before positive result to swab 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 or participation in any clinical trial 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 electronic informed consent signature); 5. Clinically significant abnormal physical findings which could interfere with the objectives of the study; 6. Diseases: a) HIV infection (based on the anamnesis), b) history of stroke and/or venous thromboembolism, c) known severe renal impairment: Chronic Kidney Disease (CKD) stage 3 or higher (eGFR <60 ml/min/m2), or CKD stage 4 or higher (eGFR <15 ml/min/m2), d) known liver injury (Child-Pugh Class A or higher); e) signs or symptoms of endometrial cancer; f) presence of hypoalbuminemia (albumin < 3.5 g/dL) that may interfere with the aim of the study. 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, use of any antiretroviral medication, any drug that cannot be co-administered with the experimental compound. 11. Pregnancy: positive or missing pregnancy test at screening visit or day 1, pregnant or lactating women; 12. Women of childbearing potential and fertile men who doesn’t 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 SARS-CoV-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 and at day 28 after randomization;; Proportion of participants who doesn't requires supplemental oxygen therapy (NEWS <=2) and/or mechanical ventilation at day 7 and 28 after randomization;; Proportion of patients in each category at time 0, 7, 14 and 28 after randomization;; Mean value of category at time 0,7,14 and 28 after randomization;; Proportion of participants with any adverse event (grade = 2 according to CTCAE) at day 7, 14 and 28 after randomization;; Proportion of participants with severe adverse events (grade = 3 according to CTCAE) 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 marker including (D-dimer, CPK, LDH).; Quality of life questionnaire 3 months after the randomization.;Timepoint(s) of evaluation of this end point: At day 14 and 28 after randomization;; At day 7 and 28 after randomization; At time 0, 7, 14 and 28 after randomization; At time 0,7,14 and 28 after randomization;; At day 7, 14 and 28 after randomization;; At day 7, 14 and 28 after randomization; At day 7, 14 and 28 after randomization;; At day 7, 14 and 28 after randomization; From base line to day 7, 14, 21 and 28 after randomization; 3 months after the randomization. | — |
Countries
Italy
Contacts
Public ContactFlavio Mantelli
Dompé farmaceutici S.p.A.
Outcome results
None listed