A Randomized, Double-Blind, Placebo-Controlled, Clinical Trial to Evaluate the Safety, Tolerability, Efficacy, and Pharmacodynamics for the Treatment of COVID-19.
Primary Purpose
Covid19
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ADX-629
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Covid19
Eligibility Criteria
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.
Sites / Locations
- Medical Research Center of Miami II, Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
ADX-629 300 mg administered orally twice daily (BID) for up to 28 days.
Placebo administered orally BID for up to 28 days.
Arm Description
Outcomes
Primary Outcome Measures
Adverse Events
Adverse Event Collection
Secondary Outcome Measures
National Institute of Allergy and Infectious Diseases (NIAID) ordinal scale score.
1- 8 Scale (Death - No limitations on activities )
Full Information
NCT ID
NCT04847544
First Posted
April 13, 2021
Last Updated
September 26, 2022
Sponsor
Aldeyra Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04847544
Brief Title
A Randomized, Double-Blind, Placebo-Controlled, Clinical Trial to Evaluate the Safety, Tolerability, Efficacy, and Pharmacodynamics for the Treatment of COVID-19.
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
March 31, 2021 (Actual)
Primary Completion Date
October 15, 2021 (Actual)
Study Completion Date
October 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aldeyra Therapeutics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ADX-629 300 mg administered orally twice daily (BID) for up to 28 days.
Arm Type
Experimental
Arm Title
Placebo administered orally BID for up to 28 days.
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ADX-629
Intervention Description
ADX-629 administered orally twice daily (BID) for up to 28 days.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo administered orally BID for up to 28 days.
Primary Outcome Measure Information:
Title
Adverse Events
Description
Adverse Event Collection
Time Frame
Safety Assessment Period (Day 1 - 28)
Secondary Outcome Measure Information:
Title
National Institute of Allergy and Infectious Diseases (NIAID) ordinal scale score.
Description
1- 8 Scale (Death - No limitations on activities )
Time Frame
Day 1 - 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Medical Research Center of Miami II, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Randomized, Double-Blind, Placebo-Controlled, Clinical Trial to Evaluate the Safety, Tolerability, Efficacy, and Pharmacodynamics for the Treatment of COVID-19.
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