COVID-19Phase 2NCT04801017
A Study to Evaluate the Safety and Efficacy of OT-101+Artemisinin in Hospitalized COVID-19 Subjects
A Phase 2 study testing OT-101 and Artemisinin in people with COVID-19, run by Oncotelic Inc. at 1 site in Brazil.
Trial summary
Primary Objective is to evaluate the safety and efficacy of OT-101+Artemisinin when used in combination with standard of care (SoC) in hospitalized COVID 19 subjects versus SoC+ Artemisinin+Placebo. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COVID-19
- What is being tested?
- OT-101 and Artemisinin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2021to Oct 2021
- Phase
- Phase 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalized adult male or non-pregnant, non-lactating female subjects (between 18 and 80 years), with SARS-CoV-2 (previously known as 2019-nCoV) infection that is documented by authorized diagnostic PCR test. A rapid PCR test could also be used. Confirmation that subject has COVID-19 within the last 2 weeks prior to randomization.
- Meeting WHO COVID 19 Clinical Improvement Ordinal Scale Criteria 5 (non-invasive mechanical ventilation or high-flow oxygen) or Criteria 6 (intubation and mechanical ventilation).
- O2 sat <= 93%
- Male subjects and female subjects of childbearing potential must agree to use protocol specified methods of contraception.
- Female subjects of childbearing potential and women of non childbearing potential (defined as at least 2 years postmenopausal or permanently sterilized women [bilateral tubal ligation, bilateral ovariectomy, or hysterectomy]) must have a negative serum pregnancy test at screening or pretreatment on Day 1.
- The subject or a LAR has provided written informed consent.
- The subject or the LAR is aware of the investigational nature of this study and willing to comply with protocol treatments, and other evaluations listed in the ICF.
Who cannot join
- Participation in any other clinical trial of an experimental treatment for COVID-19 or participation in another interventional clinical trial, including an expanded access trial.
- Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS CoV 2 infection <24 hours prior to study drug dosing except for remdesivir.
- Uncontrolled hypertension (systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg), unstable angina, congestive heart failure of any New York Respiratory Association classification, serious cardiac arrhythmia requiring treatment (exceptions: atrial fibrillation, paroxysmal supraventricular tachycardia), or history of myocardial infarction within 12 months of enrollment.
- Hypotension requiring vasoactive peptides, such as dopamine, norepinephrine, epinephrine, or dobutamine.
- Renal function impairment (creatinine clearance [Cr. Cl.] <50 mL/min, based on Modification of Diet in Renal Disease calculation).
- Liver function impairment
Show all 19Show fewer
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5 × upper limit of normal (ULN), or ALT/AST >3 × ULN plus total bilirubin >2 × ULN.
- Total bilirubin >1.5 × ULN, unless the subject has known Gilbert's syndrome.
- Platelet count <50 000/µL
- Multi-organ failure.
- Document active infection with a bacterial pathogen requiring parenteral systemic antibiotics.
- Bacterial or fungal sepsis.
- History of live vaccination within the last 4 weeks prior to study enrollment; subjects must not receive live, attenuated influenza vaccine (eg, FluMist) within 4 weeks before enrolment or at any time during the study.
- History of an allergic reaction or hypersensitivity to the study drug or any component of the study drug formulation.
- Anti-inflammatory treatments other than steroids (eg, complement inhibitor, anti-GM-CSF antibody, anti-IL6 antibody) ARE PROHIBITED. However, antiviral drugs (eg, remdesivir,), systemic corticosteroids, and non steroidal anti inflammatory drugs (NSAIDs) ARE ALLOWED.
- Presence of any uncontrolled concomitant illness, serious illness, medical conditions, or other medical history, including laboratory results, which, in the Investigator's opinion, would be likely to interfere with their participation in the study.
- Major surgical procedure within 4 weeks prior to screening or anticipation of need for major surgical procedure during the course of the study.
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to screening
- History of organ allograft.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Praxis Pesquisa Medica S / S Ltda
Jardim
Marcelo Bacci, MD, +55 11 2759-8377, mrbacci@yahoo.com
About this study
Official title: A Double Blind, Randomized, Placebo Controlled, Multi Center Study of OT-101 in Hospitalized COVID-19 Subjects
Primary Objective is to evaluate the safety and efficacy of OT-101+Artemisinin when used in combination with standard of care (SoC) in hospitalized COVID 19 subjects versus SoC+ Artemisinin+Placebo.
Read the detailed description
This is a randomized, double blind, placebo controlled study to evaluate the efficacy, safety and tolerability of OT-101+Artemisinin when used in combination with SoC in hospitalized subjects with severe COVID 19. Written informed consent must be obtained from all subjects or their legally authorized representative (LAR) during screening (up to Day 3 prior to dosing) and prior to study related procedures being performed. Following completion of all screening assessments and meeting of eligibility criteria, subjects will be enrolled and randomized on Day 1 to either receive OT-101+Artemisinin or placebo+Artemisinin in a 2:1 ratio for 7 days in combination with SoC therapy per local SoC policies, followed to Day 28.
Subjects: includes subjects with severe COVID 19 (WHO COVID 19 Clinical Improvement Ordinal Scale 5 - non-invasive ventilation or high flow oxygen, or 6 - intubation and mechanical ventilation) at screening.
Subjects will undergo assessment during hospitalization or could discontinue their treatment with OT 101 or placebo during the 7 day infusion period or any time later during the study. All subjects will be closely monitored for adverse events (AEs) from signing the informed consent form (ICF) for at least 21 days after the final dose of study treatment (until Day 28). Standard of care treatment may continue as clinically indicated (after the 7 day dosing completion) as per local institutional guidelines. If subjects are discharged after Day 7 (after completing dosing), post discharge assessments can be done either at home (home health visit) or at the site. For subjects who are discharged before Day 28 or who withdraw from the study early will have follow up phone calls or will be followed up at site or a home visit to collect safety data until End of Study on Day 28. On days of laboratory assessments, discharged subjects may have a home visit.
- Conditions
- COVID-19
- Being tested
- OT-101, Artemisinin, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OT-101Drug
Also called Trabedersen
TGF β2 specific synthetic 18 mer phosphorothioate antisense oligodeoxynucleotide
ArtemisininDrug
Also called ArtiVeda
Herbal Supplement/ Purified extract from Artemisia
PlaceboDrug
Also called Normal saline
0.9% sodium chloride injection
| Study group | Role | What they receive |
|---|---|---|
| OT-101 + Artemisinin + Standard of Care | Experimental | OT-101 - Days 1 to 7: 140 mg/m2 daily intravenous (i.v.) infusion for 7 continuous days.
Artemisinin: Days 1 to 5: 500 mg per day for 5 days by oral Receives: Drug: OT-101; Drug: Artemisinin |
| Placebo + Artemisinin + Standard of Care | Placebo comparator | Artemisinin: Days 1 to 5: 500 mg per day for 5 days by oral Receives: Drug: Artemisinin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects with clinical improvement score measured by an 8-point WHO COVID-19 Clinical Improvement Ordinal Scale as assessed by the odds ratio (OR) at Day 14.
Clinical improvement is defined as
- A score decrease to categories 1, 2, 3, or 4.
Measured: at Day 14
Secondary outcomes (10)
The OR at Days 7, 21, and 28 based on the clinical improvement score (as measured by an 8 point WHO COVID 19 Clinical Improvement Ordinal Scale).
Clinical improvement defined as per primary endpoint.
Measured: at Day 7, 21, 28
The OR at Days 7, 14, 21, and 28 of a decrease of at least 1, 2, 3, and 4 points in subjects with severe COVID 19.
Measured: at Day 7, 14, 21, 28
Time to at least 2 point improvement from baseline on Days 7, 14, 21, and 28 in subjects with severe COVID 19.
Measured: at Day 7, 14, 21, 28
Worsening (increase in clinical improvement score) of at least '1' score on Days 7, 14, 21, and 28.
Measured: at Day 7, 14, 21, 28
Mortality by Days 7, 14, 21, and 28.
Measured: up to Day 28
Duration of supplemental oxygen/ventilator support by Days 7, 14, 21, and 28.
Measured: up to Day 28
Duration of intensive care unit stay by Days 7, 14, 21, and 28.
Measured: up to Day 28
Duration of hospitalization by Days 7, 14, 21, and 28.
Measured: up to Day 28
Ventilator free days by Day 14 and Day 28.
Measured: up to Day 28
Days on ventilation.
Measured: up to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study startApr 2021 (estimated)
- Primary completionAug 2021 (estimated)
- Study completionOct 2021 (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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oncotelic Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vuong Trieu, PhD, Study director, Oncotelic Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04801017
- Sponsor's protocol ID
- C002 2020 01
- Status last verified
- Feb 2021
- First submitted
- 1 Mar 2021
- Last updated
- 16 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Randomized, Placebo Controlled, Multi Center Study of OT-101 in Hospitalized COVID-19 Subjects
- ClinicalTrials.gov ID
- NCT04801017
- Acronym / sponsor ID
- C002 2020 01
- Conditions
- COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Oncotelic Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2021 (estimated)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 16 Mar 2021 (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.
Primary Objective is to evaluate the safety and efficacy of OT-101+Artemisinin when used in combination with standard of care (SoC) in hospitalized COVID 19 subjects versus SoC+ Artemisinin+Placebo.
Detailed description
This is a randomized, double blind, placebo controlled study to evaluate the efficacy, safety and tolerability of OT-101+Artemisinin when used in combination with SoC in hospitalized subjects with severe COVID 19. Written informed consent must be obtained from all subjects or their legally authorized representative (LAR) during screening (up to Day 3 prior to dosing) and prior to study related procedures being performed. Following completion of all screening assessments and meeting of eligibility criteria, subjects will be enrolled and randomized on Day 1 to either receive OT-101+Artemisinin or placebo+Artemisinin in a 2:1 ratio for 7 days in combination with SoC therapy per local SoC policies, followed to Day 28.
Subjects: includes subjects with severe COVID 19 (WHO COVID 19 Clinical Improvement Ordinal Scale 5 - non-invasive ventilation or high flow oxygen, or 6 - intubation and mechanical ventilation) at screening.
Subjects will undergo assessment during hospitalization or could discontinue their treatment with OT 101 or placebo during the 7 day infusion period or any time later during the study. All subjects will be closely monitored for adverse events (AEs) from signing the informed consent form (ICF) for at least 21 days after the final dose of study treatment (until Day 28). Standard of care treatment may continue as clinically indicated (after the 7 day dosing completion) as per local institutional guidelines. If subjects are discharged after Day 7 (after completing dosing), post discharge assessments can be done either at home (home health visit) or at the site. For subjects who are discharged before Day 28 or who withdraw from the study early will have follow up phone calls or will be followed up at site or a home visit to collect safety data until End of Study on Day 28. On days of laboratory assessments, discharged subjects may have a home visit.
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 |
|---|---|---|
| OT-101 + Artemisinin + Standard of Care | Experimental | Drug: OT-101, Drug: ArtemisininOT-101 - Days 1 to 7: 140 mg/m2 daily intravenous (i.v.) infusion for 7 continuous days. Artemisinin: Days 1 to 5: 500 mg per day for 5 days by oral |
| Placebo + Artemisinin + Standard of Care | Placebo comparator | Drug: Artemisinin, Drug: PlaceboArtemisinin: Days 1 to 5: 500 mg per day for 5 days by oral |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Hospitalized adult male or non-pregnant, non-lactating female subjects (between 18 and 80 years), with SARS-CoV-2 (previously known as 2019-nCoV) infection that is documented by authorized diagnostic PCR test. A rapid PCR test could also be used. Confirmation that subject has COVID-19 within the last 2 weeks prior to randomization.
- Meeting WHO COVID 19 Clinical Improvement Ordinal Scale Criteria 5 (non-invasive mechanical ventilation or high-flow oxygen) or Criteria 6 (intubation and mechanical ventilation).
- O2 sat <= 93%
- Male subjects and female subjects of childbearing potential must agree to use protocol specified methods of contraception.
- Female subjects of childbearing potential and women of non childbearing potential (defined as at least 2 years postmenopausal or permanently sterilized women [bilateral tubal ligation, bilateral ovariectomy, or hysterectomy]) must have a negative serum pregnancy test at screening or pretreatment on Day 1.
Key exclusion criteria (19 listed)
- Participation in any other clinical trial of an experimental treatment for COVID-19 or participation in another interventional clinical trial, including an expanded access trial.
- Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS CoV 2 infection <24 hours prior to study drug dosing except for remdesivir.
- Uncontrolled hypertension (systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg), unstable angina, congestive heart failure of any New York Respiratory Association classification, serious cardiac arrhythmia requiring treatment (exceptions: atrial fibrillation, paroxysmal supraventricular tachycardia), or history of myocardial infarction within 12 months of enrollment.
- Hypotension requiring vasoactive peptides, such as dopamine, norepinephrine, epinephrine, or dobutamine.
- Renal function impairment (creatinine clearance [Cr. Cl.] <50 mL/min, based on Modification of Diet in Renal Disease calculation).
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 |
|---|---|---|
| OT-101Also: TrabedersenTGF β2 specific synthetic 18 mer phosphorothioate antisense oligodeoxynucleotide | Drug | OT-101 + Artemisinin + Standard of Care |
| ArtemisininAlso: ArtiVedaHerbal Supplement/ Purified extract from Artemisia | Drug | OT-101 + Artemisinin + Standard of Care, Placebo + Artemisinin + Standard of Care |
| PlaceboAlso: Normal saline0.9% sodium chloride injection | Drug | Placebo + Artemisinin + Standard of Care |
Primary outcome
The proportion of subjects with clinical improvement score measured by an 8-point WHO COVID-19 Clinical Improvement Ordinal Scale as assessed by the odds ratio (OR) at Day 14.
Time frame: at Day 14
Clinical improvement is defined as • A score decrease to categories 1, 2, 3, or 4.
10 secondary outcomes
The OR at Days 7, 21, and 28 based on the clinical improvement score (as measured by an 8 point WHO COVID 19 Clinical Improvement Ordinal Scale).
Time frame: at Day 7, 21, 28
The OR at Days 7, 14, 21, and 28 of a decrease of at least 1, 2, 3, and 4 points in subjects with severe COVID 19.
Time frame: at Day 7, 14, 21, 28
Time to at least 2 point improvement from baseline on Days 7, 14, 21, and 28 in subjects with severe COVID 19.
Time frame: at Day 7, 14, 21, 28
Worsening (increase in clinical improvement score) of at least '1' score on Days 7, 14, 21, and 28.
Time frame: at Day 7, 14, 21, 28
Mortality by Days 7, 14, 21, and 28.
Time frame: up to Day 28
Duration of supplemental oxygen/ventilator support by Days 7, 14, 21, and 28.
Time frame: up to Day 28
Duration of intensive care unit stay by Days 7, 14, 21, and 28.
Time frame: up to Day 28
Duration of hospitalization by Days 7, 14, 21, and 28.
Time frame: up to Day 28
Ventilator free days by Day 14 and Day 28.
Time frame: up to Day 28
Days on ventilation.
Time frame: up to Day 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2021.
- Individual participant dataSharing planned: No
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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.
Vuong Trieu, PhD study director
Oncotelic Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OT-101 and Artemisinin in people with COVID-19, run by Oncotelic Inc. 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 7 inclusion and 19 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 16 Mar 2021. 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 phase mean?
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 Federico Lerner, MD (54 (911) 2852.0457, federico@latinaba.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of subjects with clinical improvement score measured by an 8-point WHO COVID-19 Clinical Improvement Ordinal Scale as assessed by the odds ratio (OR) at Day 14. (time frame: at Day 14). 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 16 Mar 2021.