COVID-19Phase 1/2WP1122NCT05365321
Clinical Trial of Efficacy and Safety of Oral Drug in Adult Patients With COVID-19
A Phase 1/2 study testing WP1122 in people with COVID-19 and Mechanical Ventilation Complication, run by Andrei Carvalho Sposito at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Mechanical Ventilation Complication, COVID-19 Acute Respiratory Distress Syndrome
- What is being tested?
- WP1122
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2022to Oct 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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)
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
- Being tested
- WP1122
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WP1122Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| WP1122 | Experimental | Experimental drug with Concentration 100mg/mL - administered q12h PO for 10 days Receives: Drug: WP1122 |
| placebo | Placebo comparator | Placebo Administered q12h PO for 10 days Receives: Drug: WP1122 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through the last day of observation (day 10)
Secondary outcomes (1)
COVID-19 negativity
The time to COVID-19 negativity in patients receiving WP1122 or placebo
Measured: through the last day of observation (day 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study startDec 2022 (estimated)
- Primary completionFeb 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andrei Carvalho Sposito
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Andrei Carvalho Sposito, University of Campinas, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05365321
- Sponsor's protocol ID
- BHS5
- Acronym
- WP1122
- Status last verified
- May 2022
- First submitted
- 26 Apr 2022
- Last updated
- 9 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The results of this study will be published under the direction of the Principal Investigator. Results will not be published without prior review by Moleculin Biotech, Inc. To avoid disclosures that could jeopardize proprietary rights, the Investigational Site and the Investigator agree to certain restrictions on publications (e.g., abstracts, speeches, posters, manuscripts, and electronic communications), as detailed in the clinical trial agreement. The publication or presentation of any study results shall comply with all applicable privacy laws, including, but not limited to, HIPAA (Health Insurance Portability and Accountability Act) or equivalent.
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05365321
- Acronym / sponsor ID
- WP1122 / BHS5
- Conditions
- COVID-19, Mechanical Ventilation Complication, COVID-19 Acute Respiratory Distress Syndrome
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Andrei Carvalho SpositoUniversity, hospital or other
- Study start
- Dec 2022 (estimated)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 9 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WP1122 | Experimental | Drug: WP1122Experimental drug with Concentration 100mg/mL - administered q12h PO for 10 days |
| placebo | Placebo comparator | Drug: WP1122Placebo Administered q12h PO for 10 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WP1122Doses 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. | Drug | WP1122, placebo |
Primary outcome
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
1 secondary outcome
COVID-19 negativity
Time frame: through the last day of observation (day 10)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
- Individual participant dataSharing planned: Yes. The results of this study will be published under the direction of the Principal Investigator. Results will not be published without prior review by Moleculin Biotech, Inc. To avoid disclosures that could jeopardize proprietary rights, the Investigational Site and the Investigator agree to certain restrictions on publications (e.g., abstracts, speeches, posters, manuscripts, and electronic communications), as detailed in the clinical trial agreement. The publication or presentation of any study results shall comply with all applicable privacy laws, including, but not limited to, HIPAA (Health Insurance Portability and Accountability Act) or equivalent.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing WP1122 in people with COVID-19 and Mechanical Ventilation Complication, run by Andrei Carvalho Sposito at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrei Sposito, PhD (+55 (19) 3521-9580, andreisposito@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in the Area Under the Curve (AUC) of Interleukin-6 (IL-6) concentrations (time frame: through the last day of observation (day 10)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2022.