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NCT05365321 | Not yet recruiting | COVID-19

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

Andrei Carvalho Sposito

Information provided by (Responsible Party):

Andrei Carvalho Sposito

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.

Condition or disease

COVID-19

Mechanical Ventilation Complication

COVID-19 Acute Respiratory Distress Syndrome

Intervention/treatment

WP1122

Phase

Phase 1

Phase 2

Study Type : Interventional
Estimated Enrollment : 75 participants
Masking : Triple
Primary Purpose : Treatment
Official Title : 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)
Actual Study Start Date : December 2022
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : October 2023
Arm Intervention/treatment

Experimental: WP1122

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

Drug: WP1122

Placebo Comparator: placebo

Placebo Administered q12h PO for 10 days

Drug: WP1122
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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;
  • 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)
Clinical Trial of Efficacy and Safety of Oral Drug in Adult Patients With COVID-19

Location Details

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

How to Participate

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Locations

Not yet recruiting

Brazil, SP

University of Campinas

Campinas, SP, Brazil, 13083-887