Study of CPI-006 as Immunotherapy for Hospitalized COVID-19 Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04464395|
Recruitment Status : Completed
First Posted : July 9, 2020
Last Update Posted : July 21, 2021
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Drug: CPI-006 Other: Standard of Care||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Immunotherapy of COVID-19 With B-Cell Activating CPI-006 Monoclonal Antibody|
|Actual Study Start Date :||July 1, 2020|
|Actual Primary Completion Date :||March 1, 2021|
|Actual Study Completion Date :||July 9, 2021|
Experimental: CPI-006 Dose Escalation
CPI-006 + Standard of Care
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 Care Only
Other: Standard of Care
Participants will receive standard of care treatment only.
- 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.
- 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). ]Time to two consecutive negative nasal swab PCR SARS CoV-2 viral tests.
- Duration of symptoms [ Time Frame: Up to 24 weeks after dose of CPI-006. ]Duration of COVID-19 related symptoms.
- Time to discharge [ Time Frame: Up to 24 weeks after dose of CPI-006. ]Time to discharge from hospital.
- Rate of medical procedures [ Time Frame: Up to 24 weeks after dose of CPI-006. ]Rate of medical procedures during hospitalization.
- Difference in changes in serum/plasma immunoglobulin anti-SARS CoV-2 levels [ Time Frame: Baseline and visits through Day 28. ]Difference between Active Arm and Control Arm patients in terms of changes in serum or plasma immunoglobulin anti-SARS CoV-2 levels.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04464395
|United States, California|
|El Centro Regional Medical Center|
|El Centro, California, United States, 92243|
|United States, New York|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
|United States, Pennsylvania|
|Temple University Hospital|
|Philadelphia, Pennsylvania, United States, 19140|
|Study Chair:||S. Mahabhashyam, MD. MPH||Corvus Pharmaceuticals|