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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05365321
Other study ID # BHS5
Secondary ID
Status Not yet recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date December 2022
Est. completion date October 2023

Study information

Verified date May 2022
Source University of Campinas, Brazil
Contact Andrei Sposito, PhD
Phone +55 (19) 3521-9580
Email andreisposito@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 75
Est. completion date October 2023
Est. primary completion date February 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Brazil University of Campinas Campinas SP

Sponsors (1)

Lead Sponsor Collaborator
Andrei Carvalho Sposito

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 COVID-19 negativity The time to COVID-19 negativity in patients receiving WP1122 or placebo through the last day of observation (day 10)
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