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

NCT ID: NCT05365321

Last Updated: 2022-05-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-31
• Study Completion Date: 2023-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

WP1122

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

Group Type: EXPERIMENTAL

WP1122

Intervention Type: 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.

placebo

Placebo Administered q12h PO for 10 days

Group Type: PLACEBO_COMPARATOR

WP1122

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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;
• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Andrei Carvalho Sposito

OTHER

Sponsor Role: lead

Responsible Party

Andrei Carvalho Sposito

Principal Investigator and Full Professor of Cardiology

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

University of Campinas

Campinas, São Paulo, Brazil

Countries

Brazil

Central Contacts

Andrei Sposito, PhD

Role: CONTACT

andreisposito@gmail.com

+55 (19) 3521-9580

Other Identifiers

BHS5

Identifier Type: -

Identifier Source: org_study_id