COVID-19Phase 1NCT04464395
Study of CPI-006 as Immunotherapy for Hospitalized COVID-19 Patients
A Phase 1 study testing CPI-006 in people with COVID-19, run by Corvus Pharmaceuticals, Inc. at 3 sites in United States.
Trial summary
This Phase 1 single-dose, dose-escalation study is an open label trial evaluating the safety of CPI-006, a humanized monoclonal antibody targeting the CD73 cell-surface ectonucleotidase, as immunotherapy for stable hospitalized mild or moderately symptomatic COVID-19 patients with a parallel non-randomized Control Arm… 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?
- CPI-006
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Jul 2020to 9 Jul 2021
- Phase
- Phase 1
- 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
- Nasal swab test positive by reverse transcriptase PCR for SARS CoV-2 within past 7 days, and onset of COVID-19 symptoms no more than 10 days prior to the positive test
- Hospitalized and have stable mild to moderate symptoms of COVID-19
- Blood oxygen saturation of a minimum of 92% on either no oxygen or up to 5L/min supplemental oxygen
- Patients with cancer must be in remission or have stable, controlled disease and may be actively receiving drugs or biologics not deemed by the investigator to likely affect immune response.
- Women must not be of child bearing potential or agree to use contraceptive guidance for 6 weeks
Who cannot join
- Patients receiving previous invasive mechanical ventilation or non-invasive ventilation (CPAP, BiPAP) for COVID-19 illness
- Patients hospitalized >7 days prior to receiving study intervention
- Other diseases or conditions that are not controlled
- On drugs or biologics that are immunosuppressive, cytotoxic or immunomodulatory
- Patients with autoimmune disease must be controlled on non immunosuppressive or immune modifying agents
- Have received cytotoxic, immunosuppressive or immunomodulatory agents within past 3 months (other than for treatment of COVID-19).
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- Patients receiving experimental therapies that are immunosuppressive
- Patients receiving non-immuno-suppressive experimental therapies within 7 days prior to receiving CPI-006
- Patients receiving convalescent plasma within 24 hours prior to receiving CPI-006
- Patients receiving experimental anti-SARS CoV-2 monoclonal antibodies within past 30 days
Trial locations and contacts
3 sites in 1 country.
United States3 sites
El Centro Regional Medical Center
El Centro, California, 92243
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Temple University Hospital
Philadelphia, Pennsylvania, 19140
About this study
Official title: Immunotherapy of COVID-19 With B-Cell Activating CPI-006 Monoclonal Antibody
This Phase 1 single-dose, dose-escalation study is an open label trial evaluating the safety of CPI-006, a humanized monoclonal antibody targeting the CD73 cell-surface ectonucleotidase, as immunotherapy for stable hospitalized mild or moderately symptomatic COVID-19 patients with a parallel non-randomized Control Arm for treatment with standard of care only.
- Conditions
- COVID-19
- Being tested
- CPI-006, Standard of Care
- Keywords
- SARS CoV-2, Coronavirus, Covid
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPI-006Drug
Participants will receive a single dose of CPI-006 at one of four dose levels (0.3 mg/kg, 1.0 mg/kg, 3.0 mg/kg, or 5.0 mg/kg) along with standard of care.
Standard of CareOther
Participants will receive standard of care treatment only.
| Study group | Role | What they receive |
|---|---|---|
| CPI-006 Dose Escalation | Experimental | CPI-006 + Standard of Care Receives: Drug: CPI-006 |
| Control Arm | Other | Standard of Care Only Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events to Determine Single Dose of CPI-006 That is Safe in Patients with COVID-19
Incidence of adverse events (including serious adverse events and dose limiting toxicities).
Measured: Up to 30 days after dose of CPI-006.
Immunoglobulin Anti-SARS CoV-2 Levels
Measure changes in serum or plasma immunoglobulin anti-SARS CoV-2 levels.
Measured: Baseline and Day 28.
Secondary outcomes (5)
Negative Nasal Swab Polymerase Chain Reaction (PCR) SARS CoV-2 Viral Tests
Time to two consecutive negative nasal swab PCR SARS CoV-2 viral tests.
Measured: Baseline to two consecutive negative nasal swab PCR SARS CoV-2 viral tests (separated by at least 48 hours).
Duration of symptoms
Duration of COVID-19 related symptoms.
Measured: Up to 24 weeks after dose of CPI-006.
Time to discharge
Time to discharge from hospital.
Measured: Up to 24 weeks after dose of CPI-006.
Rate of medical procedures
Rate of medical procedures during hospitalization.
Measured: Up to 24 weeks after dose of CPI-006.
Difference in changes in serum/plasma immunoglobulin anti-SARS CoV-2 levels
Difference between Active Arm and Control Arm patients in terms of changes in serum or plasma immunoglobulin anti-SARS CoV-2 levels.
Measured: Baseline and visits through Day 28.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start1 Jul 2020
- Primary completion1 Mar 2021
- Study completion9 Jul 2021
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corvus Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- S. Mahabhashyam, MD. MPH, Study chair, Corvus Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04464395
- Sponsor's protocol ID
- CPI-006-002
- Status last verified
- Jul 2021
- First submitted
- 7 Jul 2020
- Last updated
- 21 Jul 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 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunotherapy of COVID-19 With B-Cell Activating CPI-006 Monoclonal Antibody
- ClinicalTrials.gov ID
- NCT04464395
- Acronym / sponsor ID
- CPI-006-002
- Conditions
- COVID-19
- Keywords
- SARS CoV-2, Coronavirus, Covid
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Corvus Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 9 Jul 2021 (actual)
- First posted
- 9 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.
This Phase 1 single-dose, dose-escalation study is an open label trial evaluating the safety of CPI-006, a humanized monoclonal antibody targeting the CD73 cell-surface ectonucleotidase, as immunotherapy for stable hospitalized mild or moderately symptomatic COVID-19 patients with a parallel non-randomized Control Arm for treatment with standard of care only.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPI-006 Dose Escalation | Experimental | Drug: CPI-006CPI-006 + Standard of Care |
| Control Arm | Other | Other: Standard of CareStandard of Care Only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Nasal swab test positive by reverse transcriptase PCR for SARS CoV-2 within past 7 days, and onset of COVID-19 symptoms no more than 10 days prior to the positive test
- Hospitalized and have stable mild to moderate symptoms of COVID-19
- Blood oxygen saturation of a minimum of 92% on either no oxygen or up to 5L/min supplemental oxygen
- Patients with cancer must be in remission or have stable, controlled disease and may be actively receiving drugs or biologics not deemed by the investigator to likely affect immune response.
- Women must not be of child bearing potential or agree to use contraceptive guidance for 6 weeks
Key exclusion criteria (10 listed)
- Patients receiving previous invasive mechanical ventilation or non-invasive ventilation (CPAP, BiPAP) for COVID-19 illness
- Patients hospitalized >7 days prior to receiving study intervention
- Other diseases or conditions that are not controlled
- On drugs or biologics that are immunosuppressive, cytotoxic or immunomodulatory
- Patients with autoimmune disease must be controlled on non immunosuppressive or immune modifying agents
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 |
|---|---|---|
| CPI-006Participants will receive a single dose of CPI-006 at one of four dose levels (0.3 mg/kg, 1.0 mg/kg, 3.0 mg/kg, or 5.0 mg/kg) along with standard of care. | Drug | CPI-006 Dose Escalation |
| Standard of CareParticipants will receive standard of care treatment only. | Other | Control Arm |
Primary outcome
Incidence of Treatment-Emergent Adverse Events to Determine Single Dose of CPI-006 That is Safe in Patients with COVID-19
Time frame: Up to 30 days after dose of CPI-006.
Incidence of adverse events (including serious adverse events and dose limiting toxicities).
Immunoglobulin Anti-SARS CoV-2 Levels
Time frame: Baseline and Day 28.
Measure changes in serum or plasma immunoglobulin anti-SARS CoV-2 levels.
5 secondary outcomes
Negative Nasal Swab Polymerase Chain Reaction (PCR) SARS CoV-2 Viral Tests
Time frame: Baseline to two consecutive negative nasal swab PCR SARS CoV-2 viral tests (separated by at least 48 hours).
Duration of symptoms
Time frame: Up to 24 weeks after dose of CPI-006.
Time to discharge
Time frame: Up to 24 weeks after dose of CPI-006.
Rate of medical procedures
Time frame: Up to 24 weeks after dose of CPI-006.
Difference in changes in serum/plasma immunoglobulin anti-SARS CoV-2 levels
Time frame: Baseline and visits through Day 28.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 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.
S. Mahabhashyam, MD. MPH study chair
Corvus Pharmaceuticals
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CPI-006 in people with COVID-19, run by Corvus Pharmaceuticals, Inc. at 3 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 5 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: finished, as of the sponsor's last update on 21 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 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.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Treatment-Emergent Adverse Events to Determine Single Dose of CPI-006 That is Safe in Patients with COVID-19 (time frame: Up to 30 days after dose of CPI-006.). The study lists 2 primary outcomes in all. 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 21 Jul 2021.