Study of CPI-006 as Immunotherapy for Hospitalized COVID-19 Patients

Study Overview
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Brief Summary
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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.

Official Title
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Immunotherapy of COVID-19 With B-Cell Activating CPI-006 Monoclonal Antibody

Conditions
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COVID-19

Intervention / Treatment
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* Drug: CPI-006
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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). 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CPI-006 Dose Escalation<br>CPI-006 + Standard of Care | Drug: CPI-006<br>* 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.<br>|
| Other: Control Arm<br>Standard of Care Only | Other: Standard of Care<br>* Participants will receive standard of care treatment only.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | Baseline and Day 28. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Up to 24 weeks after dose of CPI-006. | 
| Time to discharge | Time to discharge from hospital. | Up to 24 weeks after dose of CPI-006. | 
| Rate of medical procedures | Rate of medical procedures during hospitalization. | 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. | Baseline and visits through Day 28. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SARS CoV-2, Coronavirus, Covid