E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
COVID-19 patients suffering from moderate to severe Pneumonia |
|
E.1.1.1 | Medical condition in easily understood language |
COVID-19 patients suffering from moderate to severe Pneumonia |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10035664 |
E.1.2 | Term | Pneumonia |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Safety of Bazedoxifene in patients with COVID-19 disease |
|
E.2.2 | Secondary objectives of the trial |
1.) Changes in Clinical status of patient (using 7-point ordinal scale): on Day 0, Day 5 and 21 - 28. a. Death b. Hospitalized, on invasive mechanical ventilation or ECMO c. Hospitalized, on non-invasive ventilation or high flow oxygen devices d. Hospitalized, requiring supplemental oxygen e. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) f. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical Care g. Not hospitalized
2.) Influence of patients' clinical condition (symptom score) between baseline and day 14 (or day of discharge)
3.) Monitoring the frequency of patients whose condition worsens into a critical state necessitating a ventilator;
4.) Time to normalization of chosen blood parameters;
5.) Length of hospital stay;
6.) Rate of virus elimination from HCD secretions;
7.) Occurrence of adverse events.
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Women or men aged between 18 and 75 • Presence of COVID-19 Pneumonia (clinical manifestations and Xray or CT evidence, as assessed by the treating physician); • Patient is admitted to hospital due to moderate to severe symptoms of pneumonia as per investigator opinion. • Laboratory-confirmed SARS-CoV-2 infection (e.g., by PCR, antigen) within 14 days prior to randomization; • The patient's ability to cooperate and express his/her consent with the study participation; • Women of childbearing potential must have a negative pregnancy test (urine or serum) at screening and must agree to use highly effective contraceptive method that is: o combined (estrogen and progestogen containing) or progesterone only hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable) o implantable intrauterine device o intrauterine hormone-releasing system o bilateral tubal occlusion in females o vasectomized male/partner o sexual abstinence
|
|
E.4 | Principal exclusion criteria |
• Need of pulmonary ventilation at study entry; • Need of ECMO at study entry • Known hypersensitivity to the active substance or excipients; • Pregnancy and breast-feeding; • Patients with ongoing uncontrolled cardiac, metabolic, endocrinological, hepatic, renal, neurological or psychiatric illness, in whom participation in a clinical trial could pose an additional risk at the discretion of the study physician; • History or presence of coagulopathy, history of pulmonary embolism or severe thrombosis; • Participation in another interventional treatment study with an investigational agent or use of any experimental therapy within 28 days of screening or within 5 half-lives of that investigational product, whichever was longer; • Malignancy; • Patient that is not able to swallow tablet. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Safety of Bazedoxifene in patients with COVID-19 disease |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
D28 (end of trial for the subject) |
|
E.5.2 | Secondary end point(s) |
Changes in Clinical status of patient (using 7-point ordinal scale) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Day 0, Day 5 and 21 - 28. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |