Trial Outcomes & Findings for Aprepitant Injectable Emulsion in Patients With COVID-19 (GUARDS-1) (NCT NCT04470622)

NCT ID: NCT04470622

Last Updated: 2022-08-30

Results Overview

ITT Population.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

27 participants

Primary outcome timeframe

14 Days.

Results posted on

2022-08-30

Participant Flow

One participant was prematurely randomized while failing screening eligibility. This subject was counted in both 'Screen Failures' and 'Randomized Subjects/ITT population', leading to a discrepancy between the Enrollment number in the Protocol Section (27) and the number of participants Started in the Participant Flow module (26).

Participant milestones

Participant milestones
Measure	Treatment Group 1: Aprepitant Injectable Emulsion Aprepitant injectable emulsion, 130 mg once daily (QD) for 14 days.	Treatment Group 2: Placebo Saline Placebo, QD for 14 days.
Overall Study STARTED	12	14
Overall Study COMPLETED	12	11
Overall Study NOT COMPLETED	0	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment Group 1: Aprepitant Injectable Emulsion Aprepitant injectable emulsion, 130 mg once daily (QD) for 14 days.	Treatment Group 2: Placebo Saline Placebo, QD for 14 days.
Overall Study Withdrawal by Subject	0	1
Overall Study Screen Failure	0	1
Overall Study Death	0	1

Baseline Characteristics

Aprepitant Injectable Emulsion in Patients With COVID-19 (GUARDS-1)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Group 1: Aprepitant Injectable Emulsion n=12 Participants Aprepitant injectable emulsion, 130 mg QD for 14 days.	Treatment Group 2: Placebo n=13 Participants Saline Placebo, QD for 14 days.	Total n=25 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
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	10 Participants n=7 Participants	16 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Age, Continuous	61.8 years STANDARD_DEVIATION 15.64 • n=5 Participants	57.7 years STANDARD_DEVIATION 11.93 • n=7 Participants	59.7 years STANDARD_DEVIATION 13.70 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 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
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants	13 participants n=7 Participants	25 participants n=5 Participants

PRIMARY outcome

Timeframe: 14 Days.

ITT Population.

Outcome measures

Outcome measures
Measure	Treatment Group 1: Aprepitant Injectable Emulsion n=12 Participants Aprepitant injectable emulsion, 130 mg QD for 14 days.	Treatment Group 2: Placebo n=14 Participants Saline Placebo, QD for 14 days.
Proportion of Subjects Alive and Discharged From the Hospital.	11 Participants	10 Participants

SECONDARY outcome

Timeframe: 56 Days.

Outcome measures

Outcome measures
Measure	Treatment Group 1: Aprepitant Injectable Emulsion n=12 Participants Aprepitant injectable emulsion, 130 mg QD for 14 days.	Treatment Group 2: Placebo n=14 Participants Saline Placebo, QD for 14 days.
Time to Death or Respiratory Failure, Defined as Any of the Following: Endotracheal Intubation and Mechanical Ventilation; Oxygen Delivered by High-flow Nasal Cannula; Noninvasive Positive Pressure Ventilation; Extracorporeal Membrane Oxygenation (ECMO).	NA days Interval 2.0 to The number of subjects with death or respiratory failure was too small to estimate the median	NA days Interval 4.0 to The number of subjects with death or respiratory failure was too small to estimate the median

SECONDARY outcome

Timeframe: 56 Days.

Outcome measures

Outcome measures
Measure	Treatment Group 1: Aprepitant Injectable Emulsion n=12 Participants Aprepitant injectable emulsion, 130 mg QD for 14 days.	Treatment Group 2: Placebo n=14 Participants Saline Placebo, QD for 14 days.
Time to Discharge From Hospital.	6.0 days Interval 3.0 to 8.0	8.0 days Interval 4.0 to 11.0

SECONDARY outcome

Timeframe: Days 7, 14, 28, Discharge (from 2 to 43 days; median 6 days (Aprepitant), 8 days (Placebo))

Population: Overall Number of Participants Analyzed reflects the Total Enrolled ITT Population whereas Number Analyzed in each row reflects the number of subjects with IL-6 data reported at the specified timepoint.

Outcome measures

Outcome measures
Measure	Treatment Group 1: Aprepitant Injectable Emulsion n=12 Participants Aprepitant injectable emulsion, 130 mg QD for 14 days.	Treatment Group 2: Placebo n=14 Participants Saline Placebo, QD for 14 days.
Change From Baseline in Interleukin 6 (IL-6). Baseline	18.77 pg/mL Standard Deviation 26.321	19.11 pg/mL Standard Deviation 30.098
Change From Baseline in Interleukin 6 (IL-6). Day 7	-27.98 pg/mL Standard Deviation 42.493	14.83 pg/mL Standard Deviation 65.384
Change From Baseline in Interleukin 6 (IL-6). Day 14	124.00 pg/mL Standard Deviation NA The standard deviation is not defined when the sample size is equal to 1.	204.30 pg/mL Standard Deviation 407.244
Change From Baseline in Interleukin 6 (IL-6). Day 28	-8.00 pg/mL Standard Deviation NA The standard deviation is not defined when the sample size is equal to 1.	2.90 pg/mL Standard Deviation NA The standard deviation is not defined when the sample size is equal to 1.
Change From Baseline in Interleukin 6 (IL-6). Discharge	-17.41 pg/mL Standard Deviation 30.754	-9.68 pg/mL Standard Deviation 18.107

SECONDARY outcome

Timeframe: Through Day 56

Number of subjects reporting at least on Treatment-Emergent Adverse Event. Subjects reporting more than one event are counted only once using the highest severity.

Outcome measures

Outcome measures
Measure	Treatment Group 1: Aprepitant Injectable Emulsion n=12 Participants Aprepitant injectable emulsion, 130 mg QD for 14 days.	Treatment Group 2: Placebo n=13 Participants Saline Placebo, QD for 14 days.
Incidence of Treatment-emergent Adverse Events.	8 Participants	5 Participants

Adverse Events

Treatment Group 1: Aprepitant Injectable Emulsion

Serious events: 2 serious events

Other events: 8 other events

Deaths: 0 deaths

Treatment Group 2: Placebo

Serious events: 2 serious events

Other events: 5 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Treatment Group 1: Aprepitant Injectable Emulsion n=12 participants at risk Aprepitant injectable emulsion, 130 mg QD for 14 days.	Treatment Group 2: Placebo n=13 participants at risk Saline Placebo, QD for 14 days.
Respiratory, thoracic and mediastinal disorders Respiratory failure	8.3% 1/12 • Through Day 56. One subject was prematurely randomized while failing screening eligibility. This subject was counted in both 'Screen Failures' and 'Randomized Subjects/ITT population'. ITT Population includes all subjects who are randomized. Safety Population includes all subjects who received at least one dose of any study drug (including placebo). All-Cause Mortality was assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.	7.7% 1/13 • Through Day 56. One subject was prematurely randomized while failing screening eligibility. This subject was counted in both 'Screen Failures' and 'Randomized Subjects/ITT population'. ITT Population includes all subjects who are randomized. Safety Population includes all subjects who received at least one dose of any study drug (including placebo). All-Cause Mortality was assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
Cardiac disorders Sinus node dysfunction	8.3% 1/12 • Through Day 56. One subject was prematurely randomized while failing screening eligibility. This subject was counted in both 'Screen Failures' and 'Randomized Subjects/ITT population'. ITT Population includes all subjects who are randomized. Safety Population includes all subjects who received at least one dose of any study drug (including placebo). All-Cause Mortality was assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.	0.00% 0/13 • Through Day 56. One subject was prematurely randomized while failing screening eligibility. This subject was counted in both 'Screen Failures' and 'Randomized Subjects/ITT population'. ITT Population includes all subjects who are randomized. Safety Population includes all subjects who received at least one dose of any study drug (including placebo). All-Cause Mortality was assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
Injury, poisoning and procedural complications Femur fracture	8.3% 1/12 • Through Day 56. One subject was prematurely randomized while failing screening eligibility. This subject was counted in both 'Screen Failures' and 'Randomized Subjects/ITT population'. ITT Population includes all subjects who are randomized. Safety Population includes all subjects who received at least one dose of any study drug (including placebo). All-Cause Mortality was assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.	0.00% 0/13 • Through Day 56. One subject was prematurely randomized while failing screening eligibility. This subject was counted in both 'Screen Failures' and 'Randomized Subjects/ITT population'. ITT Population includes all subjects who are randomized. Safety Population includes all subjects who received at least one dose of any study drug (including placebo). All-Cause Mortality was assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
Blood and lymphatic system disorders Blood loss anaemia	0.00% 0/12 • Through Day 56. One subject was prematurely randomized while failing screening eligibility. This subject was counted in both 'Screen Failures' and 'Randomized Subjects/ITT population'. ITT Population includes all subjects who are randomized. Safety Population includes all subjects who received at least one dose of any study drug (including placebo). All-Cause Mortality was assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.	7.7% 1/13 • Through Day 56. One subject was prematurely randomized while failing screening eligibility. This subject was counted in both 'Screen Failures' and 'Randomized Subjects/ITT population'. ITT Population includes all subjects who are randomized. Safety Population includes all subjects who received at least one dose of any study drug (including placebo). All-Cause Mortality was assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/12 • Through Day 56. One subject was prematurely randomized while failing screening eligibility. This subject was counted in both 'Screen Failures' and 'Randomized Subjects/ITT population'. ITT Population includes all subjects who are randomized. Safety Population includes all subjects who received at least one dose of any study drug (including placebo). All-Cause Mortality was assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.	7.7% 1/13 • Through Day 56. One subject was prematurely randomized while failing screening eligibility. This subject was counted in both 'Screen Failures' and 'Randomized Subjects/ITT population'. ITT Population includes all subjects who are randomized. Safety Population includes all subjects who received at least one dose of any study drug (including placebo). All-Cause Mortality was assessed in the ITT population. Serious and Other Adverse Events were assessed in the Safety Population.

Other adverse events

Additional Information

Sophie Visonneau

Heron Therapeutics, Inc.

Phone: 858-251-7232

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place