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

Sponsor

Aldeyra Therapeutics, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT04847544

Collaborator

(none)

Enrollment

Location

Arms

6.5

Actual Duration (Months)

1.7

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Covid19	Drug: ADX-629 Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

11 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Mar 31, 2021

Actual Primary Completion Date :

Oct 15, 2021

Actual Study Completion Date :

Oct 15, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Adverse Events [Safety Assessment Period (Day 1 - 28)]
Adverse Event Collection

Secondary Outcome Measures

National Institute of Allergy and Infectious Diseases (NIAID) ordinal scale score. [Day 1 - 28]
1- 8 Scale (Death - No limitations on activities )

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical Research Center of Miami II, Inc.	Miami	Florida	United States	33134

Sponsors and Collaborators

Aldeyra Therapeutics, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Aldeyra Therapeutics, Inc.

ClinicalTrials.gov Identifier:

NCT04847544

Other Study ID Numbers:

ADX-629-COVID-19-001

First Posted:

Apr 19, 2021

Last Update Posted:

May 6, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of May 6, 2022