Covid19
Conditions
Brief summary
A Randomized, Double-Blind, Placebo-Controlled, Clinical Trial to Evaluate the Safety, Tolerability, Efficacy, and Pharmacodynamics of ADX-629 Administered Orally for the Treatment of COVID-19
Interventions
DRUGADX-629
ADX-629 administered orally twice daily (BID) for up to 28 days.
DRUGPlacebo
Placebo administered orally BID for up to 28 days.
Sponsors
Aldeyra Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Is a male or female greater than or equal to18 years of age at Screening; * Is willing and able to sign and date (or has a legally authorized representative willing to sign and date) a written (or electronic) informed consent form or provide equivalent consent per Food and Drug Administration guidelines on COVID-19 clinical trials; * Has a documented, laboratory-confirmed severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection as determined by polymerase chain reaction, a SARS-CoV-2 antigen test, or another commercial or public health assay, within 3 days (72 hours) of randomization; * Has COVID-19 of moderate severity, as defined by the following: Positive testing by standard reverse transcription polymerase chain reaction assay or equivalent testing; Symptoms of illness with COVID-19, which could include any of the following: cough, fever, shortness of breath, chest pain, abdominal pain, nausea/vomiting, diarrhea, body aches, weakness/fatigue, or new loss of taste or smell; Clinical signs suggestive of illness with COVID-19, such as respiratory rate greater than or equal to 20 breaths per minute, saturation of oxygen greater than 93% on room air at sea level, or heart rate greater than or equal to 90 beats per minute; and No clinical signs indicative of severe or critical severity.
Exclusion criteria
* Has an NIAID ordinal scale score \<5; * Is on high-flow oxygen or any form of noninvasive ventilation, excluding continuous positive airway pressure (CPAP) alone for sleep disorders (e.g., obstructive sleep apnea); * Has significant cardiovascular disease, defined by myocardial infarction, arterial thromboembolism, or cerebrovascular thromboembolism within 3 months prior to randomization; symptomatic dysrhythmias or unstable dysrhythmias requiring medical therapy; angina requiring therapy; symptomatic peripheral vascular disease; New York Heart Association Class 3 or 4 congestive heart failure; Grade 3 hypertension (diastolic blood pressure greater than or equal to 100 mmHg or systolic blood pressure greater than or equal to 160 mmHg); history of congenital prolonged QT syndrome, or known dyslipidemia; * Is currently taking any investigational products, other than the study drug; * Has any other condition that, in the opinion of the Investigator, could interfere with (or for which the treatment might interfere with) the conduct of the clinical trial or interpretation of the clinical trial results or that would place the subject at undue risk by participating in the clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Serious Adverse Events | The safety assessment period was Days 1 - 28. | Safety was assessed through serious adverse event reporting. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the National Institute of Allergy and Infectious Diseases (NIAID) Scale | The efficacy assessment period was 4 weeks; baseline was defined as Day 1 prior to first dose. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ADX-629 ADX-629 300 mg administered orally BID for 28 days | 7 |
| Placebo Placebo administered orally BID for 28 days | 4 |
| Total | 11 |
Baseline characteristics
| Characteristic | ADX-629 | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 49.0 years | 55.3 years | 51.3 years |
| Race/Ethnicity, Customized Hispanic or Latino | 4 Participants | 3 Participants | 7 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 3 Participants | 1 Participants | 4 Participants |
| SARS-CoV-2 Test Severity Critical COVID-19 | 0 Participants | 0 Participants | 0 Participants |
| SARS-CoV-2 Test Severity Mild COVID-19 | 2 Participants | 1 Participants | 3 Participants |
| SARS-CoV-2 Test Severity Moderate COVID-19 | 5 Participants | 3 Participants | 8 Participants |
| SARS-CoV-2 Test Severity SARS-CoV-2 Infection without Symptoms | 0 Participants | 0 Participants | 0 Participants |
| SARS-CoV-2 Test Severity Severe COVID-19 | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 3 Participants | 2 Participants | 5 Participants |
| Sex: Female, Male Male | 4 Participants | 2 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 4 |
| other Total, other adverse events | 2 / 7 | 1 / 4 |
| serious Total, serious adverse events | 0 / 7 | 1 / 4 |
Outcome results
Primary
Number of Subjects With Serious Adverse Events
Safety was assessed through serious adverse event reporting.
Time frame: The safety assessment period was Days 1 - 28.
Population: Safety population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ADX-629 | Number of Subjects With Serious Adverse Events | 0 Participants |
| Placebo | Number of Subjects With Serious Adverse Events | 1 Participants |
Secondary
Change From Baseline in the National Institute of Allergy and Infectious Diseases (NIAID) Scale
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.
Time frame: 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)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| ADX-629 | Change From Baseline in the National Institute of Allergy and Infectious Diseases (NIAID) Scale | 0.86 score on a scale | Standard Error 0.366 |
| Placebo | Change From Baseline in the National Institute of Allergy and Infectious Diseases (NIAID) Scale | 0 score on a scale | Standard Error 0.484 |