Clinical Trial of Efficacy and Safety of Oral Drug in Adult Patients With COVID-19 (WP1122)

A Phase 1/2, Dose Escalation, and Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Oral WP1122 in Adult Patients With Advanced Coronavirus Disease 2019 (COVID-19)

This is a Phase 1, multi-center, dose escalation study that is followed by a Phase 2 randomized, double-blind, placebo-controlled study of the safety and efficacy of WP1122 administered q12h ±1 hr PO in adult patients with COVID-19 who require hospitalization with respiratory support.

The Phase 1 component will enroll COVID-19 positive patients who are symptomatic and the Phase 2 component will enroll adults with COVID-19 who require hospitalization for respiratory support and those patients requiring intubation with mechanical ventilation.

Study Overview

• Status: Not yet recruiting
• Conditions: COVID-19; Mechanical Ventilation Complication; COVID-19 Acute Respiratory Distress Syndrome
• Intervention / Treatment: Drug: WP1122

• Study Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Andrei Sposito, PhD; Phone Number: +55 (19) 3521-9580; Email: andreisposito@gmail.com

Study Locations

• Brazil
  • SP
    • Campinas, SP, Brazil, 13083-887
      • University of Campinas

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• At least 18 years of age at Screening;
• Confirmed SARS-CoV-2 viral infection by polymerase chain reaction (PCR) within 48 hours prior to first administration;
• Hospitalized patients who are symptomatic (Phase 1) and require respiratory support (Phase 2);
• Off antiviral medications for at least 7 days prior to first dose of study drug. (Antiviral agents directed for another ongoing non-SARS-COV-2 infection such as Valtrex (valacyclovir hydrochloride) for herpes simplex virus lesions are allowed;
• Written informed consent from the patient or legally authorized representative (LAR), if the patient is not able to provide informed consent due to severity of illness;
• Women of childbearing potential (WCBP) must have a negative serum pregnancy test at Screening;
• WCBP must agree to abstain from sex or use an adequate method of contraception* from the time of informed consent through the final in-person evaluations at Day 38 (± 3 days);
• Males must abstain from sex with WCBP or use an adequate method of contraception* from the time of informed consent through the final in-person evaluations at Day 38 (± 3 days).

Exclusion Criteria:

• On extracorporeal membrane oxygenation (ECMO);
• SpO2/FiO2<100 while on respiratory support
• Use of high dose of >1.0 mcg/kg/min of norepinephrine or need for rescue therapy with vasopressin;
• Bacterial or fungal infection, except for mild cutaneous infection or sinus infection. Asymptomatic bacteriuria or airway colonization of bacteria is not an exclusion criteria;
• Pregnant or lactating;
• Alanine aminotransferase (ALT), Aspartate aminotransaminase (AST) ≥5 times the upper limited of normal (ULN), bilirubin >2 times the ULN (unless previously diagnosed with Gilbert's Syndrome), or International Normalised Ratio (INR) outside of normal limits (unless prolonged due to taking anticoagulants) at Screening
• Estimated glomerular filtration rate (eGFR) <30 mL/min;
• Any condition which, in the opinion of the Investigator, places the patient at unacceptable risk if they were to participate in the study;
• Clinically relevant serious co-morbid medical conditions including, but not limited to, unstable angina, symptomatic congestive heart failure, uncontrolled hypertension, uncontrolled cardiac arrhythmias, severe hepatic impairment, active central nervous system (CNS) disease uncontrolled by standard of care, known positive status for human immunodeficiency virus (HIV), active hepatitis B or C, cirrhosis, or psychiatric illness/social situations that would limit compliance with study requirements;
• Treatment with any immunosuppressive therapy other than corticosteroids within 30 days prior to Screening;
• Treatment with another investigational drug within 30 days or 5 half-lives of drug prior to Screening, whichever is longer;
• Prior treatment with the study drug (WP1122);
• Known hypersensitivity to the inactive ingredients of the study drug (WP1122) or placebo.
• Participation in another clinical study in less than 1 year (unless justified participation by the principal investigator)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: WP1122; Experimental drug with Concentration 100mg/mL - administered q12h PO for 10 days	Drug: WP1122; Doses from 8 mg/kg will be increased in doubling increments up to 64 mg/kg in the dose escalation Phase 1 portion of the study, administered orally (PO) for 10 days q12h ±1h. The dose in Phase 2 will utilize the Maximum Tolerated Dose (MTD) established in Phase 1 and also administered PO q12h ± 1h for 10 days.
Placebo Comparator: placebo; Placebo Administered q12h PO for 10 days	Drug: WP1122; Doses from 8 mg/kg will be increased in doubling increments up to 64 mg/kg in the dose escalation Phase 1 portion of the study, administered orally (PO) for 10 days q12h ±1h. The dose in Phase 2 will utilize the Maximum Tolerated Dose (MTD) established in Phase 1 and also administered PO q12h ± 1h for 10 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in the Area Under the Curve (AUC) of Interleukin-6 (IL-6) concentrations	Co-primary efficacy endpoints will be utilized in a sequential analysis manner. The first primary efficacy endpoint will be the difference in the AUC of IL-6 concentrations from Baseline (Day 0) through Day 10. For patients who do not have IL-6 values out to Day 10, a last observation carried forward technique will be utilized	through the last day of observation (day 10)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
COVID-19 negativity	The time to COVID-19 negativity in patients receiving WP1122 or placebo	through the last day of observation (day 10)

Collaborators and Investigators

• Sponsor: Andrei Carvalho Sposito

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2022
• Primary Completion (Anticipated): February 1, 2023
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: April 26, 2022
• First Submitted That Met QC Criteria: May 6, 2022
• First Posted (Actual): May 9, 2022

Study Record Updates

• Last Update Posted (Actual): May 9, 2022
• Last Update Submitted That Met QC Criteria: May 6, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; COVID-19; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: BHS5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD Plan Description

The results of this study will be published under the direction of the Principal Investigator. Results will not be published without prior review by Moleculin Biotech, Inc. To avoid disclosures that could jeopardize proprietary rights, the Investigational Site and the Investigator agree to certain restrictions on publications (e.g., abstracts, speeches, posters, manuscripts, and electronic communications), as detailed in the clinical trial agreement.

The publication or presentation of any study results shall comply with all applicable privacy laws, including, but not limited to, HIPAA (Health Insurance Portability and Accountability Act) or equivalent.

Drug and device information, study documents

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