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)
Overview
- Phase
- Phase 1
- Intervention
- WP1122
- Conditions
- COVID-19
- Sponsor
- Andrei Carvalho Sposito
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Difference in the Area Under the Curve (AUC) of Interleukin-6 (IL-6) concentrations
- Last Updated
- 3 years ago
Overview
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.
Investigators
Andrei Carvalho Sposito
Principal Investigator and Full Professor of Cardiology
University of Campinas, Brazil
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;
- •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;
Arms & Interventions
WP1122
Experimental drug with Concentration 100mg/mL - administered q12h PO for 10 days
Intervention: WP1122
placebo
Placebo Administered q12h PO for 10 days
Intervention: WP1122
Outcomes
Primary Outcomes
Difference in the Area Under the Curve (AUC) of Interleukin-6 (IL-6) concentrations
Time Frame: through the last day of observation (day 10)
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
Secondary Outcomes
- COVID-19 negativity(through the last day of observation (day 10))