COVID-19 Clinical Trial
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.
Status | Not yet recruiting |
Enrollment | 18 |
Est. completion date | October 2021 |
Est. primary completion date | August 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: 1. 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. 2. 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). 3. O2 sat <= 93% 4. Male subjects and female subjects of childbearing potential must agree to use protocol specified methods of contraception. 5. 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. 6. The subject or a LAR has provided written informed consent. 7. 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. Exclusion Criteria: 1. 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. 2. 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. 3. 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. 4. Hypotension requiring vasoactive peptides, such as dopamine, norepinephrine, epinephrine, or dobutamine. 5. Renal function impairment (creatinine clearance [Cr. Cl.] <50 mL/min, based on Modification of Diet in Renal Disease calculation). 6. Liver function impairment 1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5 × upper limit of normal (ULN), or ALT/AST >3 × ULN plus total bilirubin >2 × ULN. 2. Total bilirubin >1.5 × ULN, unless the subject has known Gilbert's syndrome. 7. Platelet count <50 000/µL 8. Multi-organ failure. 9. Document active infection with a bacterial pathogen requiring parenteral systemic antibiotics. 10. Bacterial or fungal sepsis. 11. 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. 12. History of an allergic reaction or hypersensitivity to the study drug or any component of the study drug formulation. 13. 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. 14. 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. 15. Major surgical procedure within 4 weeks prior to screening or anticipation of need for major surgical procedure during the course of the study. 16. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to screening 17. History of organ allograft. |
Country | Name | City | State |
---|---|---|---|
Brazil | Praxis Pesquisa Medica S / S Ltda | Jardim |
Lead Sponsor | Collaborator |
---|---|
Oncotelic Inc. |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Incidence of AEs and treatment-emergent AEs (TEAEs). | up to 28 days | ||
Other | Adverse events leading to premature discontinuation of the study treatment. | up to 28 days | ||
Other | Changes in radiology tests (chest X-ray or chest computed tomography [CT]) from baseline. | up to 28 days | ||
Primary | 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. |
at Day 14 | |
Secondary | 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. | at Day 7, 21, 28 | |
Secondary | 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. | at Day 7, 14, 21, 28 | ||
Secondary | Time to at least 2 point improvement from baseline on Days 7, 14, 21, and 28 in subjects with severe COVID 19. | at Day 7, 14, 21, 28 | ||
Secondary | Worsening (increase in clinical improvement score) of at least '1' score on Days 7, 14, 21, and 28. | at Day 7, 14, 21, 28 | ||
Secondary | Mortality by Days 7, 14, 21, and 28. | up to Day 28 | ||
Secondary | Duration of supplemental oxygen/ventilator support by Days 7, 14, 21, and 28. | up to Day 28 | ||
Secondary | Duration of intensive care unit stay by Days 7, 14, 21, and 28. | up to Day 28 | ||
Secondary | Duration of hospitalization by Days 7, 14, 21, and 28. | up to Day 28 | ||
Secondary | Ventilator free days by Day 14 and Day 28. | up to Day 28 | ||
Secondary | Days on ventilation. | up to Day 28 |
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