There is one clinical trial.

Clinical Trials

1 A Phase 1, Multi-Center, Open-Label, Randomized Study to Assess Safety, Pharmacokinetics, and Efficacy of BAT2020 in Hospitalized Patients Infected With SARS-CoV-2 (COVID-19)

This is an open-Label, randomized study to assess safety, pharmacokinetics, and efficacy of BAT2020 in Hospitalized Patients Infected With COVID-19. This study is composed of two Parts: single ascending dose (Part 1) and multiple ascending dose escalation or treatment period with a double-blind, placebo-controlled design (Part 2). Part 1. Single ascending dose (SAD) SAD: The patients will receive a single IV infusion of BAT2020 on day 1, and will be followed for up to 28 days. Safety, efficacy and PK information will be collected during this period. A total of 24 subjects, 3 cohorts of 8 subjects each, will be enrolled in this study. Screening for the study will begin 3 days prior to the actual dosing. Treatment cohorts are planned as following: Cohort 1: BAT2020 1 mg/kg (n=6) + Placebo (n=2) Cohort 2: BAT2020 3 mg/kg (n=6) + Placebo (n=2) Cohort 3: BAT2020 10 mg/kg (n=6) + Placebo (n=2) 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. Part 2. Treatment Period (double-blind, Placebo-controlled study) The SMC will review safety, PK, PD, and efficacy data of each cohort prior to Part 2. Part 2 is a double-blind, placebo-controlled, multi-center, Phase 2-like study in hospitalized adult patients with laboratory confirmed SARS-CoV-2 infection. A total of 100~150 patients will be enrolled a 2-arm (1:1 randomization of BAT2020 vs. standard supportive care) or a 3-arm (1:1:1 two dosing regimens of BAT2020 vs. standard supportive care) trial with 50 patients in each arm (the sample size and statistical analysis may be amended based on emerging data from Part 1). An independent data and safety monitoring board (DSMB) will actively monitor interim data to allow early stopping for futility, efficacy, or safety. Patients will be assessed daily while hospitalized. Discharged patients will be asked to attend study visits at Days 15 and 28. All subjects will undergo a series of efficacy, safety, and laboratory assessments.

NCT04432766 COVID-19 Drug: BAT2020

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