Trial Outcomes & Findings for A Randomized, Double-Blind, Placebo-Controlled, Clinical Trial to Evaluate the Safety, Tolerability, Efficacy, and Pharmacodynamics for the Treatment of COVID-19. (NCT NCT04847544)
NCT ID: NCT04847544
Last Updated: 2025-02-17
Results Overview
Safety was assessed through serious adverse event reporting.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
11 participants
Primary outcome timeframe
The safety assessment period was Days 1 - 28.
Results posted on
2025-02-17
Participant Flow
Participant milestones
| Measure |
ADX-629
ADX-629 300 mg administered orally twice daily (BID) for 28 days
|
Placebo
Placebo administered orally BID for 28 days
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
4
|
|
Overall Study
COMPLETED
|
7
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Randomized, Double-Blind, Placebo-Controlled, Clinical Trial to Evaluate the Safety, Tolerability, Efficacy, and Pharmacodynamics for the Treatment of COVID-19.
Baseline characteristics by cohort
| Measure |
ADX-629
n=7 Participants
ADX-629 300 mg administered orally BID for 28 days
|
Placebo
n=4 Participants
Placebo administered orally BID for 28 days
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
49.0 years
n=99 Participants
|
55.3 years
n=107 Participants
|
51.3 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
SARS-CoV-2 Test Severity
SARS-CoV-2 Infection without Symptoms
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
SARS-CoV-2 Test Severity
Mild COVID-19
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
SARS-CoV-2 Test Severity
Moderate COVID-19
|
5 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
SARS-CoV-2 Test Severity
Severe COVID-19
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
SARS-CoV-2 Test Severity
Critical COVID-19
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: The safety assessment period was Days 1 - 28.Population: Safety population
Safety was assessed through serious adverse event reporting.
Outcome measures
| Measure |
ADX-629
n=7 Participants
ADX-629 300 mg administered orally BID for 28 days
|
Placebo
n=4 Participants
Placebo administered orally BID for 28 days
|
|---|---|---|
|
Number of Subjects With Serious Adverse Events
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: The efficacy assessment period was 4 weeks; baseline was defined as Day 1 prior to first dose.Population: Intent-to-treat population with last observation carried forward (LOCF)
Change from baseline in the National Institute of Allergy and Infectious Diseases (NIAID) scale, which is an eight-point ordinal scale (1 = death, 8 = not hospitalized with no limitation of activities) where a lower score indicates more severity. The least squares mean (standard error) was derived from mixed model repeated measures which included change from baseline as the response variable, treatment, day of visit, treatment-by-visit interaction as fixed effects, and baseline as a covariate.
Outcome measures
| Measure |
ADX-629
n=7 Participants
ADX-629 300 mg administered orally BID for 28 days
|
Placebo
n=4 Participants
Placebo administered orally BID for 28 days
|
|---|---|---|
|
Change From Baseline in the National Institute of Allergy and Infectious Diseases (NIAID) Scale
|
0.86 score on a scale
Standard Error 0.366
|
0 score on a scale
Standard Error 0.484
|
Adverse Events
ADX-629
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ADX-629
n=7 participants at risk
ADX-629 300 mg administered orally BID for 28 days
|
Placebo
n=4 participants at risk
Placebo administered orally BID for 28 days
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
COVID-19 with hypoxia
|
0.00%
0/7 • The period of time over which adverse events were collected was approximately 28 days.
|
25.0%
1/4 • Number of events 1 • The period of time over which adverse events were collected was approximately 28 days.
|
Other adverse events
| Measure |
ADX-629
n=7 participants at risk
ADX-629 300 mg administered orally BID for 28 days
|
Placebo
n=4 participants at risk
Placebo administered orally BID for 28 days
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.3%
1/7 • Number of events 1 • The period of time over which adverse events were collected was approximately 28 days.
|
0.00%
0/4 • The period of time over which adverse events were collected was approximately 28 days.
|
|
Reproductive system and breast disorders
Pelvic pain
|
14.3%
1/7 • Number of events 1 • The period of time over which adverse events were collected was approximately 28 days.
|
0.00%
0/4 • The period of time over which adverse events were collected was approximately 28 days.
|
|
Gastrointestinal disorders
Flatulence
|
14.3%
1/7 • Number of events 1 • The period of time over which adverse events were collected was approximately 28 days.
|
0.00%
0/4 • The period of time over which adverse events were collected was approximately 28 days.
|
|
Investigations
Elevated Alanine Aminotransferase
|
0.00%
0/7 • The period of time over which adverse events were collected was approximately 28 days.
|
25.0%
1/4 • Number of events 1 • The period of time over which adverse events were collected was approximately 28 days.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/7 • The period of time over which adverse events were collected was approximately 28 days.
|
25.0%
1/4 • Number of events 1 • The period of time over which adverse events were collected was approximately 28 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place