COVID-19Phase 2NCT04432298
Study of the Efficacy and Safety of Intravenous Pamrevlumab, in Hospitalized Participants With Acute COVID-19 Disease
A Phase 2 study testing Pamrevlumab in people with COVID-19, run by Kyntra Bio at 4 sites in United States.
Trial summary
This study evaluates the efficacy and safety of intravenous (IV) infusions of pamrevlumab when compared with placebo in participants who are hospitalized with acute COVID-19 disease. Read more about this study
- Who is it for?
- Ages 40 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Pamrevlumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 4 sitesUnited States
- Study dates
- 20 Jun 2020to 22 Mar 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Confirmed SARS-CoV-2 infection
- Respiratory compromise requiring hospitalization for COVID-19 disease as evidenced by at least one (or more) of the following criteria:
- Interstitial pneumonia on chest x-ray or high-resolution computed tomography (findings of consolidation or ground glass opacities), OR
- Peripheral capillary oxygen saturation < 94% on room air, OR
- Requiring non-invasive supplemental oxygen (such as, nasal cannula, face mask) to maintain SpO2
- Not requiring mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO) use at time of randomization
- Not participating in another clinical trial for the treatment of COVID-19 disease through Day 28
Who cannot join
- Female participants who are pregnant or nursing
- Participation in a clinical trial with another investigational drug for COVID-19 disease
- Anticipated discharge from the hospital or transfer to another hospital or long-term care facility which is not a study site within 72 hours of randomization
- History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Research Center
Detroit, Michigan, 48202
Research Center
Greensboro, North Carolina, 27403
Research Center
Philadelphia, Pennsylvania, 19107
Research Center
Philadelphia, Pennsylvania, 19140
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of the Efficacy and Safety of Intravenous Pamrevlumab, a Monoclonal Antibody Against Connective Tissue Growth Factor (CTGF), in Hospitalized Patients With Acute COVID-19 Disease
This study evaluates the efficacy and safety of intravenous (IV) infusions of pamrevlumab when compared with placebo in participants who are hospitalized with acute COVID-19 disease.
Read the detailed description
This is a randomized, double-blind, placebo-controlled, phase 2, proof-of-concept study to evaluate the efficacy and safety of IV pamrevlumab, a monoclonal antibody, against connective-tissue growth factor (CTGF), in participants hospitalized with acute COVID-19 disease.
All concomitant medications, including approved and non-approved treatments for COVID-19 (such as, hydroxychloroquine or interleukin 6 [IL-6] inhibitors), as well as supplemental oxygenation needs, will be collected and recorded. In addition, the following will be collected and recorded: documentation of Severe Acute Respiratory Syndrome coronavirus (SARS-Cov-2) infection, documentation of any other infection(s) prior to or during hospitalization, and whether or not aggressive care is withheld or withdrawn, including the reason for withholding or withdrawal of care (such as a Do Not Resuscitate/Do Not Intubate [DNR/DNI] order or a resource limitation).
- Conditions
- COVID-19
- Being tested
- Pamrevlumab, Placebo
- Keywords
- Severe Acute Respiratory Syndrome coronavirus, SARS-COV-2 infection
- Medical subject headings
- COVID-19, Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PamrevlumabDrug
Also called FG-3019
Sterile liquid for injection
PlaceboDrug
Sterile liquid for injection
| Study group | Role | What they receive |
|---|---|---|
| Pamrevlumab | Experimental | Pamrevlumab: 35 milligrams/kilogram (mg/kg) on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks Receives: Drug: Pamrevlumab |
| Placebo | Experimental | Pamrevlumab-matching placebo on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Alive Who Never Received Mechanical Ventilation and/or Extracorporeal Membrane Oxygenation (ECMO) at Day 28
Measured: Day 28
Secondary outcomes (11)
Number of Participants Alive, Discharged Home, and Not on Supplemental Oxygen at Day 28
Measured: Day 28
Number of Participants Alive Who Never Received Mechanical Ventilation and/or ECMO at Day 14
Measured: Day 14
Time to Recovery as Based on a Modified 8-Point Ordinal Scale
Recovery was defined as the first day on which the participant satisfied 1 of the following 3 categories from the 8-point ordinal scale: (1) hospitalized, not requiring supplemental oxygen; (2) Not hospitalized (discharged), but with limitation on activities and/or requiring home supplemental oxygen; (3) Not hospitalized (discharged), with no limitations on activities and not requiring supplemental oxygen).
Measured: Day 28
Days in Intensive Care Unit/Critical Care Unit (ICU/CCU) (Either on or Off Mechanical Ventilation and/or ECMO)
Days in ICU/CCU was calculated as Event end date/time - Event start data/time + 1. Participants who died in ICU/CCU before Day 28, days in ICU/CCU is calculated up to the death date. Days in ICU/CCU were censored after Day 28.
Measured: up to Day 28
Days on Mechanical Ventilation and/or ECMO
Days on Mechanical Ventilation and/or ECMO was calculated as Event end date/time - Event start data/time. Participants who died on MV/ECMO before Day 28, days on MV/ECMO is calculated up to the death date. Days on MV/ECMO are censored after Day 28.
Measured: up to Day 28
Time to Mechanical Ventilation/ECMO or All-cause Mortality
Time (number of days) from randomization to mechanical ventilation/ECMO or all-cause mortality by Day 28. Participants without the event are not included in the calculation.
Measured: up to Day 28
Number of Participants With All-cause Mortality
Measured: up to Day 28
Changes in Pressure of Arterial Oxygen to Fractional Inspired Oxygen Concentration (PaO2/FiO2) Ratio, Both as Categorical and Continuous Variables
Measured: up to Day 28
Time to Death From Any Cause
Time (number of days) from randomization to death from any cause by Day 28. Participants without the event are not included in the calculation.
Measured: up to Day 28
Change in Resting Peripheral Oxygen Saturation (SpO2) Adjusted by FiO2
Measured: up to Day 28
Change in (Non-invasive) Oxygen Supplementation Requirements
Measured: up to 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 Jun 2020
- Primary completion22 Mar 2021
- Study completion22 Mar 2021
Why it stopped: The study was terminated by Sponsor due to low enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Model description
- Proof-of-concept
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyntra Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04432298
- Sponsor's protocol ID
- FGCL-3019-098
- Status last verified
- Jun 2022
- First submitted
- 12 Jun 2020
- Last updated
- 18 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of the Efficacy and Safety of Intravenous Pamrevlumab, a Monoclonal Antibody Against Connective Tissue Growth Factor (CTGF), in Hospitalized Patients With Acute COVID-19 Disease
- ClinicalTrials.gov ID
- NCT04432298
- Acronym / sponsor ID
- FGCL-3019-098
- Conditions
- COVID-19
- Keywords
- Severe Acute Respiratory Syndrome coronavirus, SARS-COV-2 infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated by Sponsor due to low enrollment.
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Kyntra BioIndustry (pharma, biotech, devices)
- Study start
- 20 Jun 2020 (actual)
- Primary completion
- 22 Mar 2021 (actual)
- Study completion
- 22 Mar 2021 (actual)
- First posted
- 16 Jun 2020 (actual)
- Results
- Posted 18 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the efficacy and safety of intravenous (IV) infusions of pamrevlumab when compared with placebo in participants who are hospitalized with acute COVID-19 disease.
Detailed description
This is a randomized, double-blind, placebo-controlled, phase 2, proof-of-concept study to evaluate the efficacy and safety of IV pamrevlumab, a monoclonal antibody, against connective-tissue growth factor (CTGF), in participants hospitalized with acute COVID-19 disease.
All concomitant medications, including approved and non-approved treatments for COVID-19 (such as, hydroxychloroquine or interleukin 6 [IL-6] inhibitors), as well as supplemental oxygenation needs, will be collected and recorded. In addition, the following will be collected and recorded: documentation of Severe Acute Respiratory Syndrome coronavirus (SARS-Cov-2) infection, documentation of any other infection(s) prior to or during hospitalization, and whether or not aggressive care is withheld or withdrawn, including the reason for withholding or withdrawal of care (such as a Do Not Resuscitate/Do Not Intubate [DNR/DNI] order or a resource limitation).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Proof-of-concept
| Arm | Type | Receives |
|---|---|---|
| Pamrevlumab | Experimental | Drug: PamrevlumabPamrevlumab: 35 milligrams/kilogram (mg/kg) on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks |
| Placebo | Experimental | Drug: PlaceboPamrevlumab-matching placebo on Days 1, 7, 14 and 28 for a total of 4 infusions over 4 weeks |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Confirmed SARS-CoV-2 infection
- Respiratory compromise requiring hospitalization for COVID-19 disease as evidenced by at least one (or more) of the following criteria:
- Not requiring mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO) use at time of randomization
- Not participating in another clinical trial for the treatment of COVID-19 disease through Day 28
Key exclusion criteria (4 listed)
- Female participants who are pregnant or nursing
- Participation in a clinical trial with another investigational drug for COVID-19 disease
- Anticipated discharge from the hospital or transfer to another hospital or long-term care facility which is not a study site within 72 hours of randomization
- History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies
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 |
|---|---|---|
| PamrevlumabAlso: FG-3019Sterile liquid for injection | Drug | Pamrevlumab |
| PlaceboSterile liquid for injection | Drug | Placebo |
Primary outcome
Number of Participants Alive Who Never Received Mechanical Ventilation and/or Extracorporeal Membrane Oxygenation (ECMO) at Day 28
Time frame: Day 28
11 secondary outcomes
Number of Participants Alive, Discharged Home, and Not on Supplemental Oxygen at Day 28
Time frame: Day 28
Number of Participants Alive Who Never Received Mechanical Ventilation and/or ECMO at Day 14
Time frame: Day 14
Time to Recovery as Based on a Modified 8-Point Ordinal Scale
Time frame: Day 28
Days in Intensive Care Unit/Critical Care Unit (ICU/CCU) (Either on or Off Mechanical Ventilation and/or ECMO)
Time frame: up to Day 28
Days on Mechanical Ventilation and/or ECMO
Time frame: up to Day 28
Time to Mechanical Ventilation/ECMO or All-cause Mortality
Time frame: up to Day 28
Number of Participants With All-cause Mortality
Time frame: up to Day 28
Changes in Pressure of Arterial Oxygen to Fractional Inspired Oxygen Concentration (PaO2/FiO2) Ratio, Both as Categorical and Continuous Variables
Time frame: up to Day 28
Time to Death From Any Cause
Time frame: up to Day 28
Change in Resting Peripheral Oxygen Saturation (SpO2) Adjusted by FiO2
Time frame: up to Day 28
Change in (Non-invasive) Oxygen Supplementation Requirements
Time frame: up to Day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pamrevlumab in people with COVID-19, run by Kyntra Bio at 4 sites 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?
The sponsor lists 7 inclusion and 4 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: stopped early, as of the sponsor's last update on 18 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 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?
Yes. Results are posted in the registry (first posted 18 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Alive Who Never Received Mechanical Ventilation and/or Extracorporeal Membrane Oxygenation (ECMO) at Day 28 (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 18 Jul 2022.