A Phase 1/2 Study to Assess Safety and Efficacy of BAT2020 in Hospitalized COVID-19 Patients

NCT04432766 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: BAT-2020-001-CR
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized study to assess safety, pharmacokinetics, immunogenicity, and efficacy of BAT2020 in hospitalized patients infected with COVID-19. This study is composed of 2 Parts: a single ascending dose (Part 1) and single dose(s) tested in parallel with a double-blind, placebo-controlled design (Part 2). Patients also will receive best available standard of care (SOC) treatment. A data and safety monitoring board (DSMB) will be set up for the study.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events (AEs)

  SAE, TEAEs, mortality, those resulting in treatment discontinuation, and changes from baseline in safety laboratory assessments

  Day 28

Study Arms (3)

Low dose

EXPERIMENTAL

Drug: BAT2020

Medium dose

EXPERIMENTAL

Drug: BAT2020

High dose

EXPERIMENTAL

Drug: BAT2020

Interventions

BAT2020 DRUG

After a cohort completes the study on Day 28, data on safety and tolerability for each cohort will be evaluated by the Safety Monitoring Committee (SMC). Administration of the next higher dose to a new dosing cohort will be permitted only if adequate safety and tolerability have been demonstrated. If encouraging clinical benefit is observed at a certain dose level, the study may proceed to a to Part 2 based on emerging data.

High dose; Low dose; Medium dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

1. Male or nonpregnant female adult ≥18 years of age at time of enrollment. 2. Patient (or legally authorized representative) provides informed consent prior to initiation of any study procedures. 3. Agrees to the collection of nasopharyngeal swabs for virology assessment. 4. Women of childbearing potential must agree to either abstinence or use at least 1 primary form of contraception at the time of screening and for 4 months after study drug dosing. 5. Enrollment within 72 hours of hospital admission.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Bio-Thera Solutions: lead

Study Sites (1)

Snake River Research

Idaho Falls, Idaho, 83404, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2020
• First Posted: June 16, 2020
• Study Start: October 20, 2020
• Primary Completion: January 20, 2021
• Study Completion: August 18, 2021
• Last Updated: August 12, 2021

Record last verified: 2021-08

Locations

US (1)