Ignite Creation Date:
2024-05-06 @ 3:55 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04801017
Status:
UNKNOWN
Last Update Posted:
2021-03-16
First Post:
2021-03-01
Brief Title:
A Study to Evaluate the Safety and Efficacy of OT-101Artemisinin in Hospitalized COVID-19 Subjects
Sponsor:
Oncotelic Inc
Organization:
Mateon Therapeutics
Study Overview
Official Title:
A Double Blind Randomized Placebo Controlled Multi Center Study of OT-101 in Hospitalized COVID-19 Subjects
Status:
UNKNOWN
Status Verified Date:
2021-02
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary Objective is to evaluate the safety and efficacy of OT-101Artemisinin when used in combination with standard of care SoC in hospitalized COVID 19 subjects versus SoC ArtemisininPlacebo
Detailed Description:
This is a randomized double blind placebo controlled study to evaluate the efficacy safety and tolerability of OT-101Artemisinin 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-101Artemisinin or placeboArtemisinin in a 21 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None