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

NCT04847544 | Completed Phase 2 Results FDA Drug

• 1 other identifier: ADX-629-COVID-19-001
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Serious Adverse Events

  Safety was assessed through serious adverse event reporting.

  The safety assessment period was Days 1 - 28.

Secondary Outcomes (1)

• 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.

Study Arms (2)

ADX-629 300 mg administered orally twice daily (BID) for up to 28 days.

EXPERIMENTAL

Drug: ADX-629

Placebo administered orally BID for up to 28 days.

PLACEBO COMPARATOR

Drug: Placebo

Interventions

ADX-629 DRUG

ADX-629 administered orally twice daily (BID) for up to 28 days.

ADX-629 300 mg administered orally twice daily (BID) for up to 28 days.

Placebo DRUG

Placebo administered orally BID for up to 28 days.

Placebo administered orally BID for up to 28 days.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aldeyra Therapeutics, Inc.: lead

Study Sites (1)

Medical Research Center of Miami II, Inc.

Miami, Florida, 33134, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

ADX-629

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Aldeyra Therapeutics, Inc.

bcavanagh@aldeyra.com

781-257-3063

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 19, 2021
• Study Start: March 31, 2021
• Primary Completion: October 15, 2021
• Study Completion: October 15, 2021
• Last Updated: February 17, 2025
• Results First Posted: February 17, 2025

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)