COVID-19Phase 1/2NCT04432766
A Phase 1/2 Study to Assess Safety and Efficacy of BAT2020 in Hospitalized COVID-19 Patients
A Phase 1/2 study testing BAT2020 in people with COVID-19, run by Bio-Thera Solutions at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- BAT2020
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2020to 18 Aug 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
- Male or nonpregnant female adult ≥18 years of age at time of enrollment.
- Patient (or legally authorized representative) provides informed consent prior to initiation of any study procedures.
- Agrees to the collection of nasopharyngeal swabs for virology assessment.
- 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.
- Enrollment within 72 hours of hospital admission.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1/2, Multi-Center, Randomized Study to Assess Safety, Pharmacokinetics, Immunogenicity, and Efficacy of BAT2020 in Hospitalized Patients Infected With SARS-CoV-2 (COVID-19)
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
- Being tested
- BAT2020
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAT2020Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Low dose | Experimental | Not described Receives: Drug: BAT2020 |
| Medium dose | Experimental | Not described Receives: Drug: BAT2020 |
| High dose | Experimental | Not described Receives: Drug: BAT2020 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs)
SAE, TEAEs, mortality, those resulting in treatment discontinuation, and changes from baseline in safety laboratory assessments
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start20 Oct 2020 (estimated)
- Primary completion20 Jan 2021 (estimated)
- Study completion18 Aug 2021 (estimated)
Why it stopped: strategic decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bio-Thera Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04432766
- Sponsor's protocol ID
- BAT-2020-001-CR
- Status last verified
- Aug 2021
- First submitted
- 12 Jun 2020
- Last updated
- 12 Aug 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Multi-Center, Randomized Study to Assess Safety, Pharmacokinetics, Immunogenicity, and Efficacy of BAT2020 in Hospitalized Patients Infected With SARS-CoV-2 (COVID-19)
- ClinicalTrials.gov ID
- NCT04432766
- Acronym / sponsor ID
- BAT-2020-001-CR
- Conditions
- COVID-19
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: strategic decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bio-Thera SolutionsIndustry (pharma, biotech, devices)
- Study start
- 20 Oct 2020 (estimated)
- Primary completion
- 20 Jan 2021 (estimated)
- Study completion
- 18 Aug 2021 (estimated)
- First posted
- 16 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low dose | Experimental | Drug: BAT2020 |
| Medium dose | Experimental | Drug: BAT2020 |
| High dose | Experimental | Drug: BAT2020 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BAT2020After 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. | Drug | High dose, Low dose, Medium dose |
Primary outcome
Incidence of adverse events (AEs)
Time frame: Day 28
SAE, TEAEs, mortality, those resulting in treatment discontinuation, and changes from baseline in safety laboratory assessments
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BAT2020 in people with COVID-19, run by Bio-Thera Solutions at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (AEs) (time frame: Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2021.