NCT04801017

A Study to Evaluate the Safety and Efficacy of OT-101+Artemisinin in Hospitalized COVID-19 Subjects

A Double Blind, Randomized, Placebo Controlled, Multi Center Study of OT-101 in Hospitalized COVID-19 Subjects

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Oncotelic Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DRUG	OT-101	TGF β2 specific synthetic 18 mer phosphorothioate antisense oligodeoxynucleotide
DRUG	Artemisinin	Herbal Supplement/ Purified extract from Artemisia
DRUG	Placebo	0.9% sodium chloride injection

Timeline

• Start date: 2021-04-01
• Primary completion: 2021-08-01
• Completion: 2021-10-01
• First posted: 2021-03-16
• Last updated: 2021-03-16

Locations

1 site across 1 country: Brazil