COVID-19Phase 2NCT04459676
Study to Assess Efficacy and Safety Relative to Standard of Care in Patients With COVID-19 Pneumonia
A Phase 2 study of COVID-19 and Pneumonia, run by Angion Biomedica Corp at 10 sites in Brazil.
Trial summary
To assess the clinical efficacy of ANG-3777 relative to the standard of care in reducing the severity and progression of pulmonary and renal dysfunction and mortality in adult patients hospitalized with COVID-19 pneumonia Read more about this study
- Who is it for?
- Ages 18 years and older
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 10 sitesBrazil
- Study dates
- 31 Jul 2020to 30 Apr 2021
- Phase
- Phase 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
Who may be able to join
- Patient is a male or nonpregnant female 18 years of age or older.
- Patient has a positive reverse-transcriptase-polymerase-chain-reaction (RT-PCR) assay for SARS-CoV-2 in a respiratory tract sample during the current hospital admission.
- Patient has pneumonia confirmed by chest imaging.
- Patient has moderate to severe disease based on the WHO disease severity scale assessment at the time of randomization defined as:
- Score 4, only those with FiO2 > 40%
- Score 5 (Non-invasive ventilation or high-flow oxygen)
- Patient has ability to provide informed consent signed by study patient or legally acceptable representative.
- Patient has willingness and ability to comply with study-related procedures/assessments
Who cannot join
- Has an active malignancy or history of solid or hematological malignancies within 5 years prior to enrollment in the study. Patients who had basal or squamous cell carcinoma-in-situ of the skin that was diagnosed > 2 years prior to the study enrollment and not currently being treated are eligible for study enrollment.
- Patient is pregnant or breast-feeding.
- Patient, in the opinion of the investigator, is unlikely to survive for ≥48 hours from the time of screening.
- Patient has any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the patient by their participation in the study.
- Patient with alanine aminotransferase (ALT) or aspartate transaminase (AST) > 3x upper limit of normal (ULN) and/or total bilirubin > 2xULN at baseline
- Patient requires treatment with the cytochrome P450 1A2 (CYP1A2) inhibitors, ciprofloxacin (Cipro®) and/or fluvoxamine (Luvox®)
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- Patients participating in any other clinical trial with an investigational drug product or procedure
- Recipients of solid organ and/or hematopoietic cell transplantation
- Patient is known to have End Stage Renal Disease (ESRD) and was being treated with maintenance hemodialysis or peritoneal dialysis prior to the current hospitalization.
- Note: Patients who initiated RRT due to Acute Kidney Injury during their current hospitalization will be eligible for the study
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Brazil10 sites
Hospital Vera Cruz - NUPEC Nucleo de Pesquisa Clínica
Belo Horizonte, Minas Gerais
UPCLIN - Faculdade de Medicina da UNESP Campus de Botucatu
Botucatu
Pontifícia Universidade Catolica de Campinas
Campinas, São Paulo
Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Rio Grande do Sul
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (HCFMRP)
Ribeirão Preto
Hospital Alemao Oswaldo Cruz
São Paulo
Hospital Heliópolis-SP
São Paulo
Hospital Vila Nova Star
São Paulo
Irmandade da Santa Casa de Misericórdia de São
São Paulo
Santa Casa de Misericordia de Sao Paulo
São Paulo
About this study
Official title: A Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Assess Safety and Efficacy of ANG- 3777 in Patients Hospitalized With Confirmed COVID-19 Pneumonia
To assess the clinical efficacy of ANG-3777 relative to the standard of care in reducing the severity and progression of pulmonary and renal dysfunction and mortality in adult patients hospitalized with COVID-19 pneumonia
- Being tested
- Standard of Care (SOC) + ANG-3777, Standard Of Care (SOC) + Placebo
- Keywords
- COVID-19, Acute Lung Injury, Acute Respiratory Distress Syndrome, Pneumonia, Respiratory Failure, AKI
- Medical subject headings
- COVID-19, Pneumonia, Acute Lung Injury, Respiratory Distress Syndrome, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care (SOC) + ANG-3777Drug
Also called BB3, Hepatocyte growth factor mimetic
Standard of Care (SOC) + ANG-3777
Standard Of Care (SOC) + PlaceboDrug
Standard Of Care + Placebo
| Study group | Role | What they receive |
|---|---|---|
| ANG-3777 + SOC | Active comparator | ANG-3777 Administered IV for 30 min and SOC
Repeat within 24 hours after previous dosing for a total of 4 days Receives: Drug: Standard of Care (SOC) + ANG-3777 |
| Standard of Care + Placebo | Placebo comparator | Standard of Care + Placebo Receives: Drug: Standard Of Care (SOC) + Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients alive, without the need for mechanical ventilation and free of the need for RRT (on an ongoing basis) at Day 28
Measured: From the time of randomization until (Day 1) until death or until Day28, whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start31 Jul 2020
- Primary completion30 Apr 2021 (estimated)
- Study completion30 Apr 2021 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Angion Biomedica Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CTI Clinical Trial and Consulting Services
- Responsible party
- Sponsor
- Investigators
- John Neylan, MD, Study director, Angion Biomedica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04459676
- Sponsor's protocol ID
- ANG3777-ALI-201
- Status last verified
- Apr 2021
- First submitted
- 3 Jul 2020
- Last updated
- 15 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Assess Safety and Efficacy of ANG- 3777 in Patients Hospitalized With Confirmed COVID-19 Pneumonia
- ClinicalTrials.gov ID
- NCT04459676
- Acronym / sponsor ID
- ANG3777-ALI-201
- Keywords
- COVID-19, Acute Lung Injury, Acute Respiratory Distress Syndrome, Pneumonia, Respiratory Failure, AKI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Angion Biomedica CorpIndustry (pharma, biotech, devices)
- Collaborators
- CTI Clinical Trial and Consulting Services
- Study start
- 31 Jul 2020 (actual)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 7 Jul 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.
To assess the clinical efficacy of ANG-3777 relative to the standard of care in reducing the severity and progression of pulmonary and renal dysfunction and mortality in adult patients hospitalized with COVID-19 pneumonia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ANG-3777 + SOC | Active comparator | Drug: Standard of Care (SOC) + ANG-3777ANG-3777 Administered IV for 30 min and SOC Repeat within 24 hours after previous dosing for a total of 4 days |
| Standard of Care + Placebo | Placebo comparator | Drug: Standard Of Care (SOC) + PlaceboStandard of Care + Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient is a male or nonpregnant female 18 years of age or older.
- Patient has a positive reverse-transcriptase-polymerase-chain-reaction (RT-PCR) assay for SARS-CoV-2 in a respiratory tract sample during the current hospital admission.
- Patient has pneumonia confirmed by chest imaging.
- Patient has moderate to severe disease based on the WHO disease severity scale assessment at the time of randomization defined as:
- Patient has ability to provide informed consent signed by study patient or legally acceptable representative.
Key exclusion criteria (10 listed)
- Has an active malignancy or history of solid or hematological malignancies within 5 years prior to enrollment in the study. Patients who had basal or squamous cell carcinoma-in-situ of the skin that was diagnosed > 2 years prior to the study enrollment and not currently being treated are eligible for study enrollment.
- Patient is pregnant or breast-feeding.
- Patient, in the opinion of the investigator, is unlikely to survive for ≥48 hours from the time of screening.
- Patient has any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the patient by their participation in the study.
- Patient with alanine aminotransferase (ALT) or aspartate transaminase (AST) > 3x upper limit of normal (ULN) and/or total bilirubin > 2xULN at baseline
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 |
|---|---|---|
| Standard of Care (SOC) + ANG-3777Also: BB3, Hepatocyte growth factor mimeticStandard of Care (SOC) + ANG-3777 | Drug | ANG-3777 + SOC |
| Standard Of Care (SOC) + PlaceboStandard Of Care + Placebo | Drug | Standard of Care + Placebo |
Primary outcome
Proportion of patients alive, without the need for mechanical ventilation and free of the need for RRT (on an ongoing basis) at Day 28
Time frame: From the time of randomization until (Day 1) until death or until Day28, whichever comes first
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 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.
John Neylan, MD study director
Angion Biomedica
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of COVID-19 and Pneumonia, run by Angion Biomedica Corp at 10 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 15 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Brazil. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
Results are not available in the source record.
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?
Proportion of patients alive, without the need for mechanical ventilation and free of the need for RRT (on an ongoing basis) at Day 28 (time frame: From the time of randomization until (Day 1) until death or until Day28, whichever comes first). 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 15 Apr 2021.