Trial Outcomes & Findings for Multicenter Double Blind, Parallel-group Phase 2/3 Trial, to Study Raloxifene in Adult COVID-19 Patients. (NCT NCT05172050)

NCT ID: NCT05172050

Last Updated: 2023-12-26

Results Overview

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" .

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

61 participants

Primary outcome timeframe

At Day 7

Results posted on

2023-12-26

Participant Flow

Actual recruitment was greatly slower than expected and this determined a significant delay in study conduction, which in turn reflected on a study completion forecast that was not in line with Sponsor's planning.

Due to the premature study interruption, the sample size was smaller than that originally planned due to several reason that caused difficulties in patients enrolment.

Participant milestones

Participant milestones
Measure	Group 1: Raloxifene 60 mg After an administration of two oral doses in the first day of treatment (one dose in the morning and one dose in the evening, each dose administered with 2 capsules containing 60 mg of the active substance or placebo), a single daily oral dose of raloxifene 60 mg was administered; the treatment was taken by the patients for two weeks. Raloxifene: Raloxifene was administered as 60 mg hard gelatine capsule(s) once a day. Starting from day 2 of treatment: one single capsule (plus one of placebo to guarantee the blinding) containing 60 mg raloxifene was administered in Group 1, and 2 capsules 60 mg each for a total of 120 mg in Group 2.	Group 2: Raloxifene 120 mg After an administration of two oral doses in the first day of treatment (one dose in the morning and one dose in the evening, each dose administered with 2 capsules containing 60 mg of the active substance or placebo), a single daily oral dose of raloxifene 120 mg was administered; the treatment was taken by the patients for two weeks. Raloxifene: Raloxifene was administered as 60 mg hard gelatine capsule(s) once a day. Starting from day 2 of treatment: one single capsule (plus one of placebo to guarantee the blinding) containing 60 mg raloxifene was administered in Group 1, and 2 capsules 60 mg each for a total of 120 mg in Group 2.	Group 3: Placebo. After an administration of two oral doses in the first day of treatment (one dose in the morning and one dose in the evening, each dose administered with 2 capsules containing placebo), a single daily oral dose of placebo (2 capsules guarantee the blinding design) was administered; the treatment was taken by the patients for two weeks. Placebo: Placebo was administered orally once a day as 2 capsules (for maintaining the blinding design)
Overall Study STARTED	22	20	19
Overall Study Full Analysis Set Population (FAS)	22	20	19
Overall Study Per-Protocol Population (PP)	18	17	17
Overall Study Safety Population (SAF)	22	20	19
Overall Study COMPLETED	10	9	8
Overall Study NOT COMPLETED	12	11	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1: Raloxifene 60 mg After an administration of two oral doses in the first day of treatment (one dose in the morning and one dose in the evening, each dose administered with 2 capsules containing 60 mg of the active substance or placebo), a single daily oral dose of raloxifene 60 mg was administered; the treatment was taken by the patients for two weeks. Raloxifene: Raloxifene was administered as 60 mg hard gelatine capsule(s) once a day. Starting from day 2 of treatment: one single capsule (plus one of placebo to guarantee the blinding) containing 60 mg raloxifene was administered in Group 1, and 2 capsules 60 mg each for a total of 120 mg in Group 2.	Group 2: Raloxifene 120 mg After an administration of two oral doses in the first day of treatment (one dose in the morning and one dose in the evening, each dose administered with 2 capsules containing 60 mg of the active substance or placebo), a single daily oral dose of raloxifene 120 mg was administered; the treatment was taken by the patients for two weeks. Raloxifene: Raloxifene was administered as 60 mg hard gelatine capsule(s) once a day. Starting from day 2 of treatment: one single capsule (plus one of placebo to guarantee the blinding) containing 60 mg raloxifene was administered in Group 1, and 2 capsules 60 mg each for a total of 120 mg in Group 2.	Group 3: Placebo. After an administration of two oral doses in the first day of treatment (one dose in the morning and one dose in the evening, each dose administered with 2 capsules containing placebo), a single daily oral dose of placebo (2 capsules guarantee the blinding design) was administered; the treatment was taken by the patients for two weeks. Placebo: Placebo was administered orally once a day as 2 capsules (for maintaining the blinding design)
Overall Study Negative Nasopharyngeal swab	5	5	3
Overall Study Development of AE or unacceptable toxicity	5	4	7
Overall Study Other	2	2	1

Baseline Characteristics

Multicenter Double Blind, Parallel-group Phase 2/3 Trial, to Study Raloxifene in Adult COVID-19 Patients.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Raloxifene 60 mg (FAS) n=22 Participants After an administration of two oral doses in the first day of treatment (one dose in the morning and one dose in the evening, each dose administered with 2 capsules containing 60 mg of the active substance or placebo), a single daily oral dose of raloxifene 60 mg was administered; the treatment was taken by the patients for two weeks. Raloxifene: Raloxifene was administered as 60 mg hard gelatine capsule(s) once a day. Starting from day 2 of treatment: one single capsule (plus one of placebo to guarantee the blinding) containing 60 mg raloxifene was administered in Group 1, and 2 capsules 60 mg each for a total of 120 mg in Group 2.	Raloxifene 120 mg (FAS) n=20 Participants After an administration of two oral doses in the first day of treatment (one dose in the morning and one dose in the evening, each dose administered with 2 capsules containing 60 mg of the active substance or placebo), a single daily oral dose of raloxifene 120 mg was administered; the treatment was taken by the patients for two weeks. Raloxifene: Raloxifene was administered as 60 mg hard gelatine capsule(s) once a day. Starting from day 2 of treatment: one single capsule (plus one of placebo to guarantee the blinding) containing 60 mg raloxifene was administered in Group 1, and 2 capsules 60 mg each for a total of 120 mg in Group 2.	Placebo (FAS) n=19 Participants After an administration of two oral doses in the first day of treatment (one dose in the morning and one dose in the evening, each dose administered with 2 capsules containing placebo), a single daily oral dose of placebo (2 capsules guarantee the blinding design) was administered; the treatment was taken by the patients for two weeks. Placebo: Placebo was administered orally once a day as 2 capsules (for maintaining the blinding design)	Total n=61 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants	15 Participants n=7 Participants	15 Participants n=5 Participants	48 Participants n=4 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	13 Participants n=4 Participants
Age, Continuous	55.1 years STANDARD_DEVIATION 10.88 • n=5 Participants	58.9 years STANDARD_DEVIATION 10.03 • n=7 Participants	54.6 years STANDARD_DEVIATION 9.33 • n=5 Participants	56.2 years STANDARD_DEVIATION 10.15 • n=4 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	8 Participants n=7 Participants	9 Participants n=5 Participants	28 Participants n=4 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	12 Participants n=7 Participants	10 Participants n=5 Participants	33 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants	20 Participants n=7 Participants	19 Participants n=5 Participants	61 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment Italy	22 participants n=5 Participants	20 participants n=7 Participants	19 participants n=5 Participants	61 participants n=4 Participants

PRIMARY outcome

Timeframe: At Day 7

Population: 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.

Outcome measures

Outcome measures
Measure	Raloxifene 60 mg n=22 Participants After an administration of two oral doses in the first day of treatment (one dose in the morning and one dose in the evening, each dose administered with 2 capsules containing 60 mg of the active substance or placebo), a single daily oral dose of raloxifene 60 mg was administered; the treatment was taken by the patients for two weeks. Raloxifene: Raloxifene was administered as 60 mg hard gelatine capsule(s) once a day. Starting from day 2 of treatment: one single capsule (plus one of placebo to guarantee the blinding) containing 60 mg raloxifene was administered in Group 1, and 2 capsules 60 mg each for a total of 120 mg in Group 2.	Raloxifene 120 mg n=20 Participants After an administration of two oral doses in the first day of treatment (one dose in the morning and one dose in the evening, each dose administered with 2 capsules containing 60 mg of the active substance or placebo), a single daily oral dose of raloxifene 120 mg was administered; the treatment was taken by the patients for two weeks. Raloxifene: Raloxifene was administered as 60 mg hard gelatine capsule(s) once a day. Starting from day 2 of treatment: one single capsule (plus one of placebo to guarantee the blinding) containing 60 mg raloxifene was administered in Group 1, and 2 capsules 60 mg each for a total of 120 mg in Group 2.	Placebo n=19 Participants After an administration of two oral doses in the first day of treatment (one dose in the morning and one dose in the evening, each dose administered with 2 capsules containing placebo), a single daily oral dose of placebo (2 capsules guarantee the blinding design) was administered; the treatment was taken by the patients for two weeks. Placebo: Placebo was administered orally once a day as 2 capsules (for maintaining the blinding design)
Number of Participants With Undetectable SARS-CoV-2 at PCR at Day 7 After Randomization in the FAS	7 Participants	4 Participants	0 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Raloxifene 60 mg n=22 Participants After an administration of two oral doses in the first day of treatment (one dose in the morning and one dose in the evening, each dose administered with 2 capsules containing 60 mg of the active substance or placebo), a single daily oral dose of raloxifene 60 mg was administered; the treatment was taken by the patients for two weeks. Raloxifene: Raloxifene was administered as 60 mg hard gelatine capsule(s) once a day. Starting from day 2 of treatment: one single capsule (plus one of placebo to guarantee the blinding) containing 60 mg raloxifene was administered in Group 1, and 2 capsules 60 mg each for a total of 120 mg in Group 2.	Raloxifene 120 mg n=20 Participants After an administration of two oral doses in the first day of treatment (one dose in the morning and one dose in the evening, each dose administered with 2 capsules containing 60 mg of the active substance or placebo), a single daily oral dose of raloxifene 120 mg was administered; the treatment was taken by the patients for two weeks. Raloxifene: Raloxifene was administered as 60 mg hard gelatine capsule(s) once a day. Starting from day 2 of treatment: one single capsule (plus one of placebo to guarantee the blinding) containing 60 mg raloxifene was administered in Group 1, and 2 capsules 60 mg each for a total of 120 mg in Group 2.	Placebo n=19 Participants After an administration of two oral doses in the first day of treatment (one dose in the morning and one dose in the evening, each dose administered with 2 capsules containing placebo), a single daily oral dose of placebo (2 capsules guarantee the blinding design) was administered; the treatment was taken by the patients for two weeks. Placebo: Placebo was administered orally once a day as 2 capsules (for maintaining the blinding design)
Number of Participants Not Requiring Oxygen Therapy and/or Mechanical Ventilation at Day 14 After Randomization in the FAS	10 Participants	8 Participants	8 Participants

SECONDARY outcome

Timeframe: 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".

Outcome measures

Outcome measures
Measure	Raloxifene 60 mg n=22 Participants After an administration of two oral doses in the first day of treatment (one dose in the morning and one dose in the evening, each dose administered with 2 capsules containing 60 mg of the active substance or placebo), a single daily oral dose of raloxifene 60 mg was administered; the treatment was taken by the patients for two weeks. Raloxifene: Raloxifene was administered as 60 mg hard gelatine capsule(s) once a day. Starting from day 2 of treatment: one single capsule (plus one of placebo to guarantee the blinding) containing 60 mg raloxifene was administered in Group 1, and 2 capsules 60 mg each for a total of 120 mg in Group 2.	Raloxifene 120 mg n=20 Participants After an administration of two oral doses in the first day of treatment (one dose in the morning and one dose in the evening, each dose administered with 2 capsules containing 60 mg of the active substance or placebo), a single daily oral dose of raloxifene 120 mg was administered; the treatment was taken by the patients for two weeks. Raloxifene: Raloxifene was administered as 60 mg hard gelatine capsule(s) once a day. Starting from day 2 of treatment: one single capsule (plus one of placebo to guarantee the blinding) containing 60 mg raloxifene was administered in Group 1, and 2 capsules 60 mg each for a total of 120 mg in Group 2.	Placebo n=19 Participants After an administration of two oral doses in the first day of treatment (one dose in the morning and one dose in the evening, each dose administered with 2 capsules containing placebo), a single daily oral dose of placebo (2 capsules guarantee the blinding design) was administered; the treatment was taken by the patients for two weeks. Placebo: Placebo was administered orally once a day as 2 capsules (for maintaining the blinding design)
Number of Participants With Undetectable SARS-CoV-2 at PCR at Days 14 and 28 After Randomization in the FAS at Day 14	10 Participants	14 Participants	7 Participants
Number of Participants With Undetectable SARS-CoV-2 at PCR at Days 14 and 28 After Randomization in the FAS at Day 28	17 Participants	17 Participants	12 Participants

SECONDARY outcome

Timeframe: At days 7 and 28

Proportion of participants who does not require supplemental oxygen therapy (NEWS ≤ 2) and/or mechanical ventilation after randomization;

Outcome measures

Outcome measures
Measure	Raloxifene 60 mg n=22 Participants After an administration of two oral doses in the first day of treatment (one dose in the morning and one dose in the evening, each dose administered with 2 capsules containing 60 mg of the active substance or placebo), a single daily oral dose of raloxifene 60 mg was administered; the treatment was taken by the patients for two weeks. Raloxifene: Raloxifene was administered as 60 mg hard gelatine capsule(s) once a day. Starting from day 2 of treatment: one single capsule (plus one of placebo to guarantee the blinding) containing 60 mg raloxifene was administered in Group 1, and 2 capsules 60 mg each for a total of 120 mg in Group 2.	Raloxifene 120 mg n=20 Participants After an administration of two oral doses in the first day of treatment (one dose in the morning and one dose in the evening, each dose administered with 2 capsules containing 60 mg of the active substance or placebo), a single daily oral dose of raloxifene 120 mg was administered; the treatment was taken by the patients for two weeks. Raloxifene: Raloxifene was administered as 60 mg hard gelatine capsule(s) once a day. Starting from day 2 of treatment: one single capsule (plus one of placebo to guarantee the blinding) containing 60 mg raloxifene was administered in Group 1, and 2 capsules 60 mg each for a total of 120 mg in Group 2.	Placebo n=19 Participants After an administration of two oral doses in the first day of treatment (one dose in the morning and one dose in the evening, each dose administered with 2 capsules containing placebo), a single daily oral dose of placebo (2 capsules guarantee the blinding design) was administered; the treatment was taken by the patients for two weeks. Placebo: Placebo was administered orally once a day as 2 capsules (for maintaining the blinding design)
Number of Participants Not Requiring Oxygen Therapy and/or Mechanical Ventilation at Day 7 an d at Day 28 in the FAS at Day 28	9 Participants	12 Participants	7 Participants
Number of Participants Not Requiring Oxygen Therapy and/or Mechanical Ventilation at Day 7 an d at Day 28 in the FAS at Day 7	12 Participants	12 Participants	11 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Raloxifene 60 mg n=22 Participants After an administration of two oral doses in the first day of treatment (one dose in the morning and one dose in the evening, each dose administered with 2 capsules containing 60 mg of the active substance or placebo), a single daily oral dose of raloxifene 60 mg was administered; the treatment was taken by the patients for two weeks. Raloxifene: Raloxifene was administered as 60 mg hard gelatine capsule(s) once a day. Starting from day 2 of treatment: one single capsule (plus one of placebo to guarantee the blinding) containing 60 mg raloxifene was administered in Group 1, and 2 capsules 60 mg each for a total of 120 mg in Group 2.	Raloxifene 120 mg n=20 Participants After an administration of two oral doses in the first day of treatment (one dose in the morning and one dose in the evening, each dose administered with 2 capsules containing 60 mg of the active substance or placebo), a single daily oral dose of raloxifene 120 mg was administered; the treatment was taken by the patients for two weeks. Raloxifene: Raloxifene was administered as 60 mg hard gelatine capsule(s) once a day. Starting from day 2 of treatment: one single capsule (plus one of placebo to guarantee the blinding) containing 60 mg raloxifene was administered in Group 1, and 2 capsules 60 mg each for a total of 120 mg in Group 2.	Placebo n=19 Participants After an administration of two oral doses in the first day of treatment (one dose in the morning and one dose in the evening, each dose administered with 2 capsules containing placebo), a single daily oral dose of placebo (2 capsules guarantee the blinding design) was administered; the treatment was taken by the patients for two weeks. Placebo: Placebo was administered orally once a day as 2 capsules (for maintaining the blinding design)
Number of Patients in Each National Early Warning Score (NEWS) Category in the FAS Day 7 - Score 5	1 Participants	1 Participants	0 Participants
Number of Patients in Each National Early Warning Score (NEWS) Category in the FAS Day 7 - Score 0	6 Participants	5 Participants	6 Participants
Number of Patients in Each National Early Warning Score (NEWS) Category in the FAS Day 7 - Score 1	3 Participants	4 Participants	5 Participants
Number of Patients in Each National Early Warning Score (NEWS) Category in the FAS Day 7 - Score 2	3 Participants	3 Participants	0 Participants
Number of Patients in Each National Early Warning Score (NEWS) Category in the FAS Day 7 - Score 3	1 Participants	2 Participants	0 Participants
Number of Patients in Each National Early Warning Score (NEWS) Category in the FAS Day 7 - Score 4	2 Participants	0 Participants	3 Participants
Number of Patients in Each National Early Warning Score (NEWS) Category in the FAS Day 7 - Score 7	2 Participants	1 Participants	0 Participants
Number of Patients in Each National Early Warning Score (NEWS) Category in the FAS Day 7 - Missing	4 Participants	4 Participants	5 Participants
Number of Patients in Each National Early Warning Score (NEWS) Category in the FAS Day 14 - Score 0	5 Participants	4 Participants	5 Participants
Number of Patients in Each National Early Warning Score (NEWS) Category in the FAS Day 14 - Score 1	5 Participants	2 Participants	3 Participants
Number of Patients in Each National Early Warning Score (NEWS) Category in the FAS Day 14 - Score 2	1 Participants	3 Participants	0 Participants
Number of Patients in Each National Early Warning Score (NEWS) Category in the FAS Day 14 - Score 3	1 Participants	5 Participants	2 Participants
Number of Patients in Each National Early Warning Score (NEWS) Category in the FAS Day 14 - Score 4	2 Participants	1 Participants	1 Participants
Number of Patients in Each National Early Warning Score (NEWS) Category in the FAS Day 14 - Score 5	0 Participants	0 Participants	1 Participants
Number of Patients in Each National Early Warning Score (NEWS) Category in the FAS Day 14 - Score 6	1 Participants	0 Participants	1 Participants
Number of Patients in Each National Early Warning Score (NEWS) Category in the FAS Day 14 - Missing	7 Participants	5 Participants	6 Participants
Number of Patients in Each National Early Warning Score (NEWS) Category in the FAS Day 28 - Score 0	5 Participants	8 Participants	5 Participants
Number of Patients in Each National Early Warning Score (NEWS) Category in the FAS Day 28 - Score 1	4 Participants	5 Participants	3 Participants
Number of Patients in Each National Early Warning Score (NEWS) Category in the FAS Day 28 - Score 2	1 Participants	0 Participants	1 Participants
Number of Patients in Each National Early Warning Score (NEWS) Category in the FAS Day 28 - Score 3	0 Participants	0 Participants	1 Participants
Number of Patients in Each National Early Warning Score (NEWS) Category in the FAS Day 28 - Score 4	2 Participants	0 Participants	1 Participants
Number of Patients in Each National Early Warning Score (NEWS) Category in the FAS Day 28 - Missing	10 Participants	7 Participants	8 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Raloxifene 60 mg n=22 Participants After an administration of two oral doses in the first day of treatment (one dose in the morning and one dose in the evening, each dose administered with 2 capsules containing 60 mg of the active substance or placebo), a single daily oral dose of raloxifene 60 mg was administered; the treatment was taken by the patients for two weeks. Raloxifene: Raloxifene was administered as 60 mg hard gelatine capsule(s) once a day. Starting from day 2 of treatment: one single capsule (plus one of placebo to guarantee the blinding) containing 60 mg raloxifene was administered in Group 1, and 2 capsules 60 mg each for a total of 120 mg in Group 2.	Raloxifene 120 mg n=20 Participants After an administration of two oral doses in the first day of treatment (one dose in the morning and one dose in the evening, each dose administered with 2 capsules containing 60 mg of the active substance or placebo), a single daily oral dose of raloxifene 120 mg was administered; the treatment was taken by the patients for two weeks. Raloxifene: Raloxifene was administered as 60 mg hard gelatine capsule(s) once a day. Starting from day 2 of treatment: one single capsule (plus one of placebo to guarantee the blinding) containing 60 mg raloxifene was administered in Group 1, and 2 capsules 60 mg each for a total of 120 mg in Group 2.	Placebo n=19 Participants After an administration of two oral doses in the first day of treatment (one dose in the morning and one dose in the evening, each dose administered with 2 capsules containing placebo), a single daily oral dose of placebo (2 capsules guarantee the blinding design) was administered; the treatment was taken by the patients for two weeks. Placebo: Placebo was administered orally once a day as 2 capsules (for maintaining the blinding design)
Mean Value of National Early Warning Score (NEWS) Category in the FAS Day 7	2.2 score on a scale Standard Deviation 2.36	1.8 score on a scale Standard Deviation 1.98	1.2 score on a scale Standard Deviation 1.58
Mean Value of National Early Warning Score (NEWS) Category in the FAS Day 14	1.6 score on a scale Standard Deviation 1.84	1.8 score on a scale Standard Deviation 1.37	1.8 score on a scale Standard Deviation 2.12
Mean Value of National Early Warning Score (NEWS) Category in the FAS Day 28	1.2 score on a scale Standard Deviation 1.47	0.4 score on a scale Standard Deviation 0.51	1.1 score on a scale Standard Deviation 1.38

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Raloxifene 60 mg n=22 Participants After an administration of two oral doses in the first day of treatment (one dose in the morning and one dose in the evening, each dose administered with 2 capsules containing 60 mg of the active substance or placebo), a single daily oral dose of raloxifene 60 mg was administered; the treatment was taken by the patients for two weeks. Raloxifene: Raloxifene was administered as 60 mg hard gelatine capsule(s) once a day. Starting from day 2 of treatment: one single capsule (plus one of placebo to guarantee the blinding) containing 60 mg raloxifene was administered in Group 1, and 2 capsules 60 mg each for a total of 120 mg in Group 2.	Raloxifene 120 mg n=20 Participants After an administration of two oral doses in the first day of treatment (one dose in the morning and one dose in the evening, each dose administered with 2 capsules containing 60 mg of the active substance or placebo), a single daily oral dose of raloxifene 120 mg was administered; the treatment was taken by the patients for two weeks. Raloxifene: Raloxifene was administered as 60 mg hard gelatine capsule(s) once a day. Starting from day 2 of treatment: one single capsule (plus one of placebo to guarantee the blinding) containing 60 mg raloxifene was administered in Group 1, and 2 capsules 60 mg each for a total of 120 mg in Group 2.	Placebo n=19 Participants After an administration of two oral doses in the first day of treatment (one dose in the morning and one dose in the evening, each dose administered with 2 capsules containing placebo), a single daily oral dose of placebo (2 capsules guarantee the blinding design) was administered; the treatment was taken by the patients for two weeks. Placebo: Placebo was administered orally once a day as 2 capsules (for maintaining the blinding design)
Number of Hospitalized Participants Who at the Beginning of the Study Were at Domicile Isolation After Randomization in the FAS Day 28	20 Participants	18 Participants	16 Participants
Number of Hospitalized Participants Who at the Beginning of the Study Were at Domicile Isolation After Randomization in the FAS Day 7	20 Participants	18 Participants	15 Participants
Number of Hospitalized Participants Who at the Beginning of the Study Were at Domicile Isolation After Randomization in the FAS Day 14	20 Participants	18 Participants	15 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Raloxifene 60 mg n=22 Participants After an administration of two oral doses in the first day of treatment (one dose in the morning and one dose in the evening, each dose administered with 2 capsules containing 60 mg of the active substance or placebo), a single daily oral dose of raloxifene 60 mg was administered; the treatment was taken by the patients for two weeks. Raloxifene: Raloxifene was administered as 60 mg hard gelatine capsule(s) once a day. Starting from day 2 of treatment: one single capsule (plus one of placebo to guarantee the blinding) containing 60 mg raloxifene was administered in Group 1, and 2 capsules 60 mg each for a total of 120 mg in Group 2.	Raloxifene 120 mg n=20 Participants After an administration of two oral doses in the first day of treatment (one dose in the morning and one dose in the evening, each dose administered with 2 capsules containing 60 mg of the active substance or placebo), a single daily oral dose of raloxifene 120 mg was administered; the treatment was taken by the patients for two weeks. Raloxifene: Raloxifene was administered as 60 mg hard gelatine capsule(s) once a day. Starting from day 2 of treatment: one single capsule (plus one of placebo to guarantee the blinding) containing 60 mg raloxifene was administered in Group 1, and 2 capsules 60 mg each for a total of 120 mg in Group 2.	Placebo n=19 Participants After an administration of two oral doses in the first day of treatment (one dose in the morning and one dose in the evening, each dose administered with 2 capsules containing placebo), a single daily oral dose of placebo (2 capsules guarantee the blinding design) was administered; the treatment was taken by the patients for two weeks. Placebo: Placebo was administered orally once a day as 2 capsules (for maintaining the blinding design)
Number of Participants Admitted to Intensive Care After Randomization in the FAS Day 7	0 Participants	0 Participants	0 Participants
Number of Participants Admitted to Intensive Care After Randomization in the FAS Day 14	0 Participants	0 Participants	0 Participants
Number of Participants Admitted to Intensive Care After Randomization in the FAS Day 28	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Raloxifene 60 mg n=22 Participants After an administration of two oral doses in the first day of treatment (one dose in the morning and one dose in the evening, each dose administered with 2 capsules containing 60 mg of the active substance or placebo), a single daily oral dose of raloxifene 60 mg was administered; the treatment was taken by the patients for two weeks. Raloxifene: Raloxifene was administered as 60 mg hard gelatine capsule(s) once a day. Starting from day 2 of treatment: one single capsule (plus one of placebo to guarantee the blinding) containing 60 mg raloxifene was administered in Group 1, and 2 capsules 60 mg each for a total of 120 mg in Group 2.	Raloxifene 120 mg n=20 Participants After an administration of two oral doses in the first day of treatment (one dose in the morning and one dose in the evening, each dose administered with 2 capsules containing 60 mg of the active substance or placebo), a single daily oral dose of raloxifene 120 mg was administered; the treatment was taken by the patients for two weeks. Raloxifene: Raloxifene was administered as 60 mg hard gelatine capsule(s) once a day. Starting from day 2 of treatment: one single capsule (plus one of placebo to guarantee the blinding) containing 60 mg raloxifene was administered in Group 1, and 2 capsules 60 mg each for a total of 120 mg in Group 2.	Placebo n=19 Participants After an administration of two oral doses in the first day of treatment (one dose in the morning and one dose in the evening, each dose administered with 2 capsules containing placebo), a single daily oral dose of placebo (2 capsules guarantee the blinding design) was administered; the treatment was taken by the patients for two weeks. Placebo: Placebo was administered orally once a day as 2 capsules (for maintaining the blinding design)
Number of Survivors in the FAS	22 Participants	20 Participants	19 Participants

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Raloxifene 60 mg n=22 Participants After an administration of two oral doses in the first day of treatment (one dose in the morning and one dose in the evening, each dose administered with 2 capsules containing 60 mg of the active substance or placebo), a single daily oral dose of raloxifene 60 mg was administered; the treatment was taken by the patients for two weeks. Raloxifene: Raloxifene was administered as 60 mg hard gelatine capsule(s) once a day. Starting from day 2 of treatment: one single capsule (plus one of placebo to guarantee the blinding) containing 60 mg raloxifene was administered in Group 1, and 2 capsules 60 mg each for a total of 120 mg in Group 2.	Raloxifene 120 mg n=20 Participants After an administration of two oral doses in the first day of treatment (one dose in the morning and one dose in the evening, each dose administered with 2 capsules containing 60 mg of the active substance or placebo), a single daily oral dose of raloxifene 120 mg was administered; the treatment was taken by the patients for two weeks. Raloxifene: Raloxifene was administered as 60 mg hard gelatine capsule(s) once a day. Starting from day 2 of treatment: one single capsule (plus one of placebo to guarantee the blinding) containing 60 mg raloxifene was administered in Group 1, and 2 capsules 60 mg each for a total of 120 mg in Group 2.	Placebo n=19 Participants After an administration of two oral doses in the first day of treatment (one dose in the morning and one dose in the evening, each dose administered with 2 capsules containing placebo), a single daily oral dose of placebo (2 capsules guarantee the blinding design) was administered; the treatment was taken by the patients for two weeks. Placebo: Placebo was administered orally once a day as 2 capsules (for maintaining the blinding design)
Quality of Life Questionnaire (EQ-5D-5L) at 3 Months After Randomization - EQ-5D Descriptive System mobility -no problems in walking about	18 Participants	12 Participants	15 Participants
Quality of Life Questionnaire (EQ-5D-5L) at 3 Months After Randomization - EQ-5D Descriptive System mobility - slight problems in walking about	1 Participants	5 Participants	2 Participants
Quality of Life Questionnaire (EQ-5D-5L) at 3 Months After Randomization - EQ-5D Descriptive System mobility - moderate problems in walking about	0 Participants	0 Participants	1 Participants
Quality of Life Questionnaire (EQ-5D-5L) at 3 Months After Randomization - EQ-5D Descriptive System mobility-severe problems in walking about	0 Participants	0 Participants	0 Participants
Quality of Life Questionnaire (EQ-5D-5L) at 3 Months After Randomization - EQ-5D Descriptive System mobility - unable to walk about	0 Participants	0 Participants	0 Participants
Quality of Life Questionnaire (EQ-5D-5L) at 3 Months After Randomization - EQ-5D Descriptive System self care - no problems washing or dressing myself	18 Participants	17 Participants	18 Participants
Quality of Life Questionnaire (EQ-5D-5L) at 3 Months After Randomization - EQ-5D Descriptive System self care - slight problems washing or dressing myself	0 Participants	0 Participants	0 Participants
Quality of Life Questionnaire (EQ-5D-5L) at 3 Months After Randomization - EQ-5D Descriptive System self care - moderate problems washing or dressing myself	1 Participants	0 Participants	0 Participants
Quality of Life Questionnaire (EQ-5D-5L) at 3 Months After Randomization - EQ-5D Descriptive System self care - severe problems washing or dressing myself	0 Participants	0 Participants	0 Participants
Quality of Life Questionnaire (EQ-5D-5L) at 3 Months After Randomization - EQ-5D Descriptive System self care - unable to wash or dress myself	0 Participants	0 Participants	0 Participants
Quality of Life Questionnaire (EQ-5D-5L) at 3 Months After Randomization - EQ-5D Descriptive System usual activities - no problems doing my usual activities	14 Participants	14 Participants	12 Participants
Quality of Life Questionnaire (EQ-5D-5L) at 3 Months After Randomization - EQ-5D Descriptive System usual activities - slight problems doing my usual activities	3 Participants	3 Participants	5 Participants
Quality of Life Questionnaire (EQ-5D-5L) at 3 Months After Randomization - EQ-5D Descriptive System usual activities - moderate problems doing my usual activities	1 Participants	0 Participants	1 Participants
Quality of Life Questionnaire (EQ-5D-5L) at 3 Months After Randomization - EQ-5D Descriptive System usual activities - severe problems doing my usual activities	1 Participants	0 Participants	0 Participants
Quality of Life Questionnaire (EQ-5D-5L) at 3 Months After Randomization - EQ-5D Descriptive System usual activities - unable to do my usual activities	0 Participants	0 Participants	0 Participants
Quality of Life Questionnaire (EQ-5D-5L) at 3 Months After Randomization - EQ-5D Descriptive System Pain/discomfort - no pain or discomfort	17 Participants	13 Participants	15 Participants
Quality of Life Questionnaire (EQ-5D-5L) at 3 Months After Randomization - EQ-5D Descriptive System Pain/discomfort - slight pain or discomfort	0 Participants	4 Participants	2 Participants
Quality of Life Questionnaire (EQ-5D-5L) at 3 Months After Randomization - EQ-5D Descriptive System Pain/discomfort - moderate pain or discomfort	1 Participants	0 Participants	0 Participants
Quality of Life Questionnaire (EQ-5D-5L) at 3 Months After Randomization - EQ-5D Descriptive System Pain/discomfort - severe pain or discomfort	1 Participants	0 Participants	1 Participants
Quality of Life Questionnaire (EQ-5D-5L) at 3 Months After Randomization - EQ-5D Descriptive System Pain/discomfort - extreme pain or discomfort	0 Participants	0 Participants	0 Participants
Quality of Life Questionnaire (EQ-5D-5L) at 3 Months After Randomization - EQ-5D Descriptive System Anxiety / Depression - I am not anxious or depressed	13 Participants	10 Participants	13 Participants
Quality of Life Questionnaire (EQ-5D-5L) at 3 Months After Randomization - EQ-5D Descriptive System Anxiety / Depression - I am slightly anxious or depressed	1 Participants	5 Participants	4 Participants
Quality of Life Questionnaire (EQ-5D-5L) at 3 Months After Randomization - EQ-5D Descriptive System Anxiety / Depression - I am moderately anxious or depressed	5 Participants	2 Participants	1 Participants
Quality of Life Questionnaire (EQ-5D-5L) at 3 Months After Randomization - EQ-5D Descriptive System Anxiety / Depression - I am severely anxious or depressed	0 Participants	0 Participants	0 Participants
Quality of Life Questionnaire (EQ-5D-5L) at 3 Months After Randomization - EQ-5D Descriptive System Anxiety / Depression - I am extremely anxious or depressed	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: At month 3 After Randomization

Outcome measures

Outcome measures
Measure	Raloxifene 60 mg n=22 Participants After an administration of two oral doses in the first day of treatment (one dose in the morning and one dose in the evening, each dose administered with 2 capsules containing 60 mg of the active substance or placebo), a single daily oral dose of raloxifene 60 mg was administered; the treatment was taken by the patients for two weeks. Raloxifene: Raloxifene was administered as 60 mg hard gelatine capsule(s) once a day. Starting from day 2 of treatment: one single capsule (plus one of placebo to guarantee the blinding) containing 60 mg raloxifene was administered in Group 1, and 2 capsules 60 mg each for a total of 120 mg in Group 2.	Raloxifene 120 mg n=20 Participants After an administration of two oral doses in the first day of treatment (one dose in the morning and one dose in the evening, each dose administered with 2 capsules containing 60 mg of the active substance or placebo), a single daily oral dose of raloxifene 120 mg was administered; the treatment was taken by the patients for two weeks. Raloxifene: Raloxifene was administered as 60 mg hard gelatine capsule(s) once a day. Starting from day 2 of treatment: one single capsule (plus one of placebo to guarantee the blinding) containing 60 mg raloxifene was administered in Group 1, and 2 capsules 60 mg each for a total of 120 mg in Group 2.	Placebo n=19 Participants After an administration of two oral doses in the first day of treatment (one dose in the morning and one dose in the evening, each dose administered with 2 capsules containing placebo), a single daily oral dose of placebo (2 capsules guarantee the blinding design) was administered; the treatment was taken by the patients for two weeks. Placebo: Placebo was administered orally once a day as 2 capsules (for maintaining the blinding design)
Quality of Life Questionnaire (EQ-5D-5L) at 3 Months After Randomization - EQ VAS	85.6 score on a scale Standard Deviation 13.7	75.2 score on a scale Standard Deviation 21.9	84.1 score on a scale Standard Deviation 11.5

Adverse Events

Raloxifene 60 mg (SAF)

Serious events: 3 serious events

Other events: 6 other events

Deaths: 0 deaths

Raloxifene 120 mg (SAF)

Serious events: 2 serious events

Other events: 8 other events

Deaths: 0 deaths

Placebo (SAF)

Serious events: 5 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Raloxifene 60 mg (SAF) n=22 participants at risk After an administration of two oral doses in the first day of treatment (one dose in the morning and one dose in the evening, each dose administered with 2 capsules containing 60 mg of the active substance or placebo), a single daily oral dose of raloxifene 60 mg was administered; the treatment was taken by the patients for two weeks. Raloxifene: Raloxifene was administered as 60 mg hard gelatine capsule(s) once a day. Starting from day 2 of treatment: one single capsule (plus one of placebo to guarantee the blinding) containing 60 mg raloxifene was administered in Group 1, and 2 capsules 60 mg each for a total of 120 mg in Group 2.	Raloxifene 120 mg (SAF) n=20 participants at risk After an administration of two oral doses in the first day of treatment (one dose in the morning and one dose in the evening, each dose administered with 2 capsules containing 60 mg of the active substance or placebo), a single daily oral dose of raloxifene 120 mg was administered; the treatment was taken by the patients for two weeks. Raloxifene: Raloxifene was administered as 60 mg hard gelatine capsule(s) once a day. Starting from day 2 of treatment: one single capsule (plus one of placebo to guarantee the blinding) containing 60 mg raloxifene was administered in Group 1, and 2 capsules 60 mg each for a total of 120 mg in Group 2.	Placebo (SAF) n=19 participants at risk After an administration of two oral doses in the first day of treatment (one dose in the morning and one dose in the evening, each dose administered with 2 capsules containing placebo), a single daily oral dose of placebo (2 capsules guarantee the blinding design) was administered; the treatment was taken by the patients for two weeks. Placebo: Placebo was administered orally once a day as 2 capsules (for maintaining the blinding design)
Gastrointestinal disorders Abdominal pain	0.00% 0/22 • The specific period of time over wich adverse events data were collected was within Day 7, 14 and 28 after randomization An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.	0.00% 0/20 • The specific period of time over wich adverse events data were collected was within Day 7, 14 and 28 after randomization An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.	5.3% 1/19 • Number of events 1 • The specific period of time over wich adverse events data were collected was within Day 7, 14 and 28 after randomization An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
General disorders Pyrexia	0.00% 0/22 • The specific period of time over wich adverse events data were collected was within Day 7, 14 and 28 after randomization An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.	5.0% 1/20 • Number of events 1 • The specific period of time over wich adverse events data were collected was within Day 7, 14 and 28 after randomization An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.	0.00% 0/19 • The specific period of time over wich adverse events data were collected was within Day 7, 14 and 28 after randomization An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
Infections and infestations Covid-19 pneumonia	4.5% 1/22 • Number of events 1 • The specific period of time over wich adverse events data were collected was within Day 7, 14 and 28 after randomization An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.	0.00% 0/20 • The specific period of time over wich adverse events data were collected was within Day 7, 14 and 28 after randomization An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.	10.5% 2/19 • Number of events 2 • The specific period of time over wich adverse events data were collected was within Day 7, 14 and 28 after randomization An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma of liver	0.00% 0/22 • The specific period of time over wich adverse events data were collected was within Day 7, 14 and 28 after randomization An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.	0.00% 0/20 • The specific period of time over wich adverse events data were collected was within Day 7, 14 and 28 after randomization An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.	5.3% 1/19 • Number of events 1 • The specific period of time over wich adverse events data were collected was within Day 7, 14 and 28 after randomization An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
Respiratory, thoracic and mediastinal disorders Cough	4.5% 1/22 • Number of events 1 • The specific period of time over wich adverse events data were collected was within Day 7, 14 and 28 after randomization An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.	0.00% 0/20 • The specific period of time over wich adverse events data were collected was within Day 7, 14 and 28 after randomization An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.	0.00% 0/19 • The specific period of time over wich adverse events data were collected was within Day 7, 14 and 28 after randomization An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
Respiratory, thoracic and mediastinal disorders Dyspnoea	4.5% 1/22 • Number of events 1 • The specific period of time over wich adverse events data were collected was within Day 7, 14 and 28 after randomization An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.	5.0% 1/20 • Number of events 1 • The specific period of time over wich adverse events data were collected was within Day 7, 14 and 28 after randomization An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.	0.00% 0/19 • The specific period of time over wich adverse events data were collected was within Day 7, 14 and 28 after randomization An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
Respiratory, thoracic and mediastinal disorders Pneumonia	4.5% 1/22 • Number of events 1 • The specific period of time over wich adverse events data were collected was within Day 7, 14 and 28 after randomization An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.	5.0% 1/20 • Number of events 1 • The specific period of time over wich adverse events data were collected was within Day 7, 14 and 28 after randomization An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.	0.00% 0/19 • The specific period of time over wich adverse events data were collected was within Day 7, 14 and 28 after randomization An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/22 • The specific period of time over wich adverse events data were collected was within Day 7, 14 and 28 after randomization An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.	5.0% 1/20 • Number of events 1 • The specific period of time over wich adverse events data were collected was within Day 7, 14 and 28 after randomization An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.	5.3% 1/19 • Number of events 1 • The specific period of time over wich adverse events data were collected was within Day 7, 14 and 28 after randomization An Adverse Event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.

Other adverse events

Additional Information

Clinical Development & Operations

Dompé Farmaceutici SpA

Phone: +39 02 583831

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place