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

NCT05365321 | Unknown Phase 1

• 1 other identifier: BHS5
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COVID-19; Mechanical Ventilation Complication; COVID-19 Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• COVID-19 negativity

  through the last day of observation (day 10)

Study Arms (2)

WP1122

EXPERIMENTAL

Experimental drug with Concentration 100mg/mL - administered q12h PO for 10 days

Drug: WP1122

placebo

PLACEBO COMPARATOR

Placebo Administered q12h PO for 10 days

Drug: WP1122

Interventions

WP1122 DRUG

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.

WP1122; placebo

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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;
• 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)

Sponsors & Collaborators

• Andrei Carvalho Sposito: lead

Study Sites (1)

University of Campinas

Campinas, São Paulo, 13083-887, Brazil

Location

MeSH Terms

Conditions

COVID-19

Interventions

3,6-di-O-acetyl-2-deoxy-D-glucopyranose

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

Central Study Contacts

Andrei Sposito, PhD

CONTACT

+55 (19) 3521-9580; andreisposito@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator and Full Professor of Cardiology

Study Record Dates

• First Submitted: April 26, 2022
• First Posted: May 9, 2022
• Study Start: December 1, 2022
• Primary Completion: February 1, 2023
• Study Completion: October 1, 2023
• Last Updated: May 9, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)