A Randomized, Double-Blind, Placebo-Controlled, Clinical Trial to Evaluate the Safety, Tolerability, Efficacy, and Pharmacodynamics for the Treatment of COVID-19.

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

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 Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Drug: ADX-629; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33134
      • Medical Research Center of Miami II, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ADX-629 300 mg administered orally twice daily (BID) for up to 28 days.	Drug: ADX-629; ADX-629 administered orally twice daily (BID) for up to 28 days.
Placebo Comparator: Placebo administered orally BID for up to 28 days.	Drug: Placebo; Placebo administered orally BID for up to 28 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With Serious Adverse Events	Safety was assessed through serious adverse event reporting.	The safety assessment period was Days 1 - 28.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	The efficacy assessment period was 4 weeks; baseline was defined as Day 1 prior to first dose.

Collaborators and Investigators

• Sponsor: Aldeyra Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2021
• Primary Completion (Actual): October 15, 2021
• Study Completion (Actual): October 15, 2021

Study Registration Dates

• First Submitted: April 13, 2021
• First Submitted That Met QC Criteria: April 13, 2021
• First Posted (Actual): April 19, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 27, 2025
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19
• Other Study ID Numbers: ADX-629-COVID-19-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No