Trial · NCT05172050
Multicenter Double Blind, Parallel-group Phase 2/3 Trial, to Study Raloxifene in Adult COVID-19 Patients.
NCT05172050, Phase 2, Phase 3, Completed, Dompé Farmaceutici S.p.A; results first posted 2023-12-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Multicenter Double Blind, Parallel-group Phase 2/3 Trial, to Study Raloxifene in Adult COVID-19 Patients. Trials, record NCT05172050. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05172050
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Multicenter Double Blind, Parallel-group Phase 2/3 Trial, to Study Raloxifene in Adult COVID-19 Patients.
- NCT number
- NCT05172050
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 61 participants, actual
- Lead sponsor
- Dompé Farmaceutici S.p.A
- Conditions
- SARS CoV 2 Infection
- Interventions
- Raloxifene, Placebo
- First posted
- 2021-12-29
- Last updated
- 2023-12-26
- Other registries' IDs
- eudract:2020-003936-25
- Results first posted
- 2023-12-14
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Undetectable SARS-CoV-2 at PCR at Day 7 After Randomization in the FAS | At Day 7 | Number of participants who, after an approved molecular test (PCR), were not detected as SARS-CoV2 positive. Based on Approved molecular test (PCR) result at day 7, the responses were considered as "detectable" if PCR result was "Positive" otherwise "undetectable" if PCR result was "Negative" . |
| Primary | Number of Participants Not Requiring Oxygen Therapy and/or Mechanical Ventilation at Day 14 After Randomization in the FAS | At Day 14 | Proportion of participants who does not require supplemental oxygen therapy (NEWS ≤ 2) and/or mechanical ventilation. NEWS is a system for scoring the physiological measurements that are routinely recorded at the patient's bedside. NEWS uses six physiological measurements. An additional two points are added if the patient is receiving oxygen therapy. The total possible score ranges from 0 to 20. If collected NEWS score \> 2 or mechanical ventilation with result "Yes" then the response was considered as "Required". If collected NEWS score ≤ 2 and mechanical ventilation with result "No" then the response was considered as "Not Required" (if both NEWS score and mechanical ventilation were missing, patient was considered as missing). |
| Secondary | Number of Participants With Undetectable SARS-CoV-2 at PCR at Days 14 and 28 After Randomization in the FAS | At days 14 and 28 after randomization | Number of participants with undetectable SARS-CoV-2 at PCR at day 14 after randomization, and at day 28 after randomization. Based on Approved molecular test (PCR) result at days 14 and 28 after randomization, the responses were considered as "detectable" if PCR result was "Positive" otherwise "undetectable" if PCR result was "Negative". |
| Secondary | Number of Participants Not Requiring Oxygen Therapy and/or Mechanical Ventilation at Day 7 an d at Day 28 in the FAS | At days 7 and 28 | Proportion of participants who does not require supplemental oxygen therapy (NEWS ≤ 2) and/or mechanical ventilation after randomization; |
| Secondary | Number of Patients in Each National Early Warning Score (NEWS) Category in the FAS | At days 7, 14, 28 | Proportion of patients in each National Early Warning Score (NEWS) category after randomization. NEWS is a system for scoring the physiological measurements that are routinely recorded at the patient's bedside. NEWS uses six physiological measurements: respiratory rate; oxygen saturation; temperature; systolic blood pressure; heart rate and level of consciousness. Each scores 0-3 and individual scores are added together for an overall score. An additional two points are added if the patient is receiving oxygen therapy. The total possible score ranges from 0 to 20. The higher the score, the worse the outcome. |
| Secondary | Mean Value of National Early Warning Score (NEWS) Category in the FAS | At days 7, 14, 28 after randomization | Mean value of National Early Warning Score (NEWS) category after randomization. NEWS is a system for scoring the physiological measurements that are routinely recorded at the patient's bedside. The total possible score ranges from 0 to 20. The higher the score the greater the clinical risk. Higher scores indicate the need for escalation, medical review and possible clinical intervention and more intensive monitoring |
| Secondary | Number of Hospitalized Participants Who at the Beginning of the Study Were at Domicile Isolation After Randomization in the FAS | At days 7, 14, 28 | Proportion of hospitalized participants at Day 7, Day 14 and Day 28 after randomization among subjects who at the beginning of the study were at domicile isolation. |
| Secondary | Number of Participants Admitted to Intensive Care After Randomization in the FAS | At days 7,14 ,28 | Proportion of participants admitted to intensive care. Intensive care is a special medical treatment in which a patient who is dangerously ill is kept under constant observation, typically in a dedicated department of a hospital. |
| Secondary | Number of Survivors in the FAS | At days 7, 14, 28 | Proportion of survivors after randomization. There were no events (i.e. deaths) in any treatment groups and thus the median overall survival could not be estimated. Overall survival was analysed according to the Kaplan-Meier method. Time to event curves were compared (i.e. comparisons of each active treatment group versus placebo) using log-rank test and estimates of hazard ratio were obtained using Cox proportional hazards model. |
| Secondary | Quality of Life Questionnaire (EQ-5D-5L) at 3 Months After Randomization - EQ-5D Descriptive System | At month 3 After Randomization | The EQ-5D-5L consists of: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-5L system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the 5 dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the 5 dimensions can be combined into a 5-digit number describing the patient's health state. In the EQ VAS - quantitative measure of health outcome - the patient records a self-rates health on a vertical visual analogue scale (numbered from 0 to 100) which goes from 'Best imaginable health state' (100) to 'Worst imaginable health state' (0). |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Undetectable SARS-CoV-2 at PCR at Day 7 After Randomization in the FAS | At Day 7 | The Full Analysis Set (FAS) population included all randomized patients who received at least one dose of the study medication. The FAS population was used for primary and secondary efficacy analyses. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants Not Requiring Oxygen Therapy and/or Mechanical Ventilation at Day 14 After Randomization in the FAS | At Day 14 | The Full Analysis Set (FAS) population included all randomized patients who received at least one dose of the study medication. The FAS population was used for primary and secondary efficacy analyses; | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Undetectable SARS-CoV-2 at PCR at Days 14 and 28 After Randomization in the FAS | At days 14 and 28 after randomization | The Full Analysis Set (FAS) population included all randomized patients who received at least one dose of the study medication. The FAS population was used for primary and secondary efficacy analyses. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Not Requiring Oxygen Therapy and/or Mechanical Ventilation at Day 7 an d at Day 28 in the FAS | At days 7 and 28 | The Full Analysis Set (FAS) population included all randomized patients who received at least one dose of the study medication. The FAS population was used for primary and secondary efficacy analyses; | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Patients in Each National Early Warning Score (NEWS) Category in the FAS | At days 7, 14, 28 | The Full Analysis Set (FAS) population included all randomized patients who received at least one dose of the study medication. The FAS population was used for primary and secondary efficacy analyses; | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Value of National Early Warning Score (NEWS) Category in the FAS | At days 7, 14, 28 after randomization | The Full Analysis Set (FAS) population included all randomized patients who received at least one dose of the study medication. The FAS population was used for primary and secondary efficacy analyses; | score on a scale | MEAN |
| SECONDARY | Number of Hospitalized Participants Who at the Beginning of the Study Were at Domicile Isolation After Randomization in the FAS | At days 7, 14, 28 | The Full Analysis Set (FAS) population included all randomized patients who received at least one dose of the study medication. The FAS population was used for primary and secondary efficacy analyses; | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Admitted to Intensive Care After Randomization in the FAS | At days 7,14 ,28 | The Full Analysis Set (FAS) population included all randomized patients who received at least one dose of the study medication. The FAS population was used for primary and secondary efficacy analyses. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Survivors in the FAS | At days 7, 14, 28 | The Full Analysis Set (FAS) population included all randomized patients who received at least one dose of the study medication. The FAS population was used for primary and secondary efficacy analyses. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Quality of Life Questionnaire (EQ-5D-5L) at 3 Months After Randomization - EQ-5D Descriptive System | At month 3 After Randomization | The Full Analysis Set (FAS) population included all randomized patients who received at least one dose of the study medication. The FAS population was used for primary and secondary efficacy analyses; | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group192
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Undetectable SARS-CoV-2 at PCR at Day 7 After Randomization in the FAS | Raloxifene 60 mg | 7 | Participants | ||
| Number of Participants With Undetectable SARS-CoV-2 at PCR at Day 7 After Randomization in the FAS | Raloxifene 120 mg | 4 | Participants | ||
| Number of Participants With Undetectable SARS-CoV-2 at PCR at Day 7 After Randomization in the FAS | Placebo | 0 | Participants | ||
| Number of Participants Not Requiring Oxygen Therapy and/or Mechanical Ventilation at Day 14 After Randomization in the FAS | Raloxifene 60 mg | 10 | Participants | ||
| Number of Participants Not Requiring Oxygen Therapy and/or Mechanical Ventilation at Day 14 After Randomization in the FAS | Raloxifene 120 mg | 8 | Participants | ||
| Number of Participants Not Requiring Oxygen Therapy and/or Mechanical Ventilation at Day 14 After Randomization in the FAS | Placebo | 8 | Participants | ||
| Number of Participants With Undetectable SARS-CoV-2 at PCR at Days 14 and 28 After Randomization in the FAS | Raloxifene 60 mg (FAS) | at Day 14 | 10 | Participants | |
| Number of Participants With Undetectable SARS-CoV-2 at PCR at Days 14 and 28 After Randomization in the FAS | Raloxifene 120 mg (FAS) | at Day 14 | 14 | Participants | |
| Number of Participants With Undetectable SARS-CoV-2 at PCR at Days 14 and 28 After Randomization in the FAS | Placebo (FAS) | at Day 14 | 7 | Participants | |
| Number of Participants With Undetectable SARS-CoV-2 at PCR at Days 14 and 28 After Randomization in the FAS | Raloxifene 60 mg (FAS) | at Day 28 | 17 | Participants |
1 to 10 of 192Source ClinicalTrials.gov
See all 192 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group 1: Raloxifene 60 mg | 22 | |
| Overall Study | STARTED | Group 2: Raloxifene 120 mg | 20 | |
| Overall Study | STARTED | Group 3: Placebo. | 19 | |
| Overall Study | Full Analysis Set Population (FAS) | Group 1: Raloxifene 60 mg | 22 | |
| Overall Study | Full Analysis Set Population (FAS) | Group 2: Raloxifene 120 mg | 20 | |
| Overall Study | Full Analysis Set Population (FAS) | Group 3: Placebo. | 19 | |
| Overall Study | Per-Protocol Population (PP) | Group 1: Raloxifene 60 mg | 18 | |
| Overall Study | Per-Protocol Population (PP) | Group 2: Raloxifene 120 mg | 17 | |
| Overall Study | Per-Protocol Population (PP) | Group 3: Placebo. | 17 | |
| Overall Study | Safety Population (SAF) | Group 1: Raloxifene 60 mg | 22 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events123
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Thrombocytosis | Blood and lymphatic system disorders | Raloxifene 60 mg (SAF) | 0 | 22 | 0 |
| other | Thrombocytosis | Blood and lymphatic system disorders | Raloxifene 120 mg (SAF) | 1 | 20 | 1 |
| other | Thrombocytosis | Blood and lymphatic system disorders | Placebo (SAF) | 0 | 19 | 0 |
| other | Tachycardia | Cardiac disorders | Raloxifene 60 mg (SAF) | 0 | 22 | 0 |
| other | Tachycardia | Cardiac disorders | Raloxifene 120 mg (SAF) | 1 | 20 | 1 |
| other | Tachycardia | Cardiac disorders | Placebo (SAF) | 0 | 19 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Raloxifene 60 mg (SAF) | 1 | 22 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Raloxifene 120 mg (SAF) | 1 | 20 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Placebo (SAF) | 1 | 19 | 1 |
| other | Dyspepsia | Gastrointestinal disorders | Raloxifene 60 mg (SAF) | 1 | 22 | 1 |
1 to 10 of 123Source ClinicalTrials.gov
See all 123 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Raloxifene 60 mg (SAF) | 0 | 22 |
| Total, all-cause mortality | Raloxifene 120 mg (SAF) | 0 | 20 |
| Total, all-cause mortality | Placebo (SAF) | 0 | 19 |
| Total, other adverse events | Raloxifene 60 mg (SAF) | 6 | 22 |
| Total, other adverse events | Raloxifene 120 mg (SAF) | 8 | 20 |
| Total, other adverse events | Placebo (SAF) | 6 | 19 |
| Total, serious adverse events | Raloxifene 60 mg (SAF) | 3 | 22 |
| Total, serious adverse events | Raloxifene 120 mg (SAF) | 2 | 20 |
| Total, serious adverse events | Placebo (SAF) | 5 | 19 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35582123 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05172050
GET https://conductscience.org/api/trials/v1/NCT05172050/results?page=2