Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:32 PM
Ignite Modification Date:
2025-12-24 @ 1:32 PM
NCT ID:
NCT04464395
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04464395
Study Brief:
Protocol Section:
NCT04464395