COVID-19, COVID-19 Acute Respiratory Distress Syndrome, Mechanical Ventilation Complication
Conditions
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.
Interventions
DRUGWP1122
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.
Sponsors
Andrei Carvalho Sposito
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in the Area Under the Curve (AUC) of Interleukin-6 (IL-6) concentrations | 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
| Measure | Time frame | Description |
|---|---|---|
| COVID-19 negativity | through the last day of observation (day 10) | The time to COVID-19 negativity in patients receiving WP1122 or placebo |
Countries
Brazil
Contacts
Primary ContactAndrei Sposito, PhD
Outcome results
None listed