COVID-19
Conditions
Interventions
INO 4800 Dose
Placebo
Sponsors
Inovio Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Working or residing in an environment with high risk of exposure to SARS-CoV-2 for whom exposure may be relatively prolonged or for whom personal protective equipment (PPE) may be inconsistently used, especially in confined settings. Phase 2 only: Screening laboratory results within normal limits for testing laboratory or are deemed not clinically significant by the Investigator. Be post-menopausal or be surgically sterile or have a partner who is sterile or use medically effective contraception with a failure rate of < 1% per year when used consistently and correctly from Screening until 3 months following last dose (Phase 2) or until last dose (Phase 3).
Exclusion criteria
Exclusion criteria: Acute febrile illness with temperature higher than or equal to 100.4°F (38.0°C) or acute onset of upper or lower respiratory tract symptoms. Positive serologic or molecular (Reverse transcription polymerase chain reaction (RT-PCR)) test for SARS-CoV-2 at Screening (this criterion applies to all Phase 2 participants and only applies after approximately 402 participants positive for SARS-CoV-2 serologic test are randomized in the Phase 3 segment of the study). Pregnant or breastfeeding or intending to become pregnant or intending to father children within the projected duration of the trial starting from the Screening visit until 3 months following the last dose (Phase 2) or until last dose (Phase 3). Known history of uncontrolled HIV based on a CD4 count less than 200 cells per cubic millimeter (/mm^3) or a detectable viral load within the past 3 months. Is currently participating or has participated in a study with an investigational product within 30 days preceding Day 0. Previous or planned receipt of an investigational (including Emergency Use Authorization (EUA) or local equivalent authorization) or licensed vaccine for prevention or treatment of COVID-19, middle east respiratory syndrome (MERS), or severe acute respiratory syndrome (SARS) (documented receipt of placebo in previous trial would be permissible for trial eligibility). Respiratory diseases (e.g., asthma, chronic obstructive pulmonary disease) requiring significant changes in therapy or hospitalization for worsening disease during the 6 weeks prior to enrolment. Immunosuppression as a result of underlying illness or treatment. Lack of acceptable sites available for ID injection and EP. Blood donation or transfusion within 1 month prior to Day 0. Reported alcohol or substance abuse or dependence, or illicit drug use (excluding marijuana use). Any illness or condition that in the opinion of the investigator may affect the safety of the participant or the evaluation of any study endpoint.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 2: Change From Baseline in Antigen-specific Cellular Immune Response Measured by Interferon-gamma (IFN-?) Enzyme-linked Immunospot (ELISpot) Assay;Phase 2: Change From Baseline in Neutralizing Antibody Response Measured by a Pseudovirus-based Neutralization Assay;Phase 3: Percentage of Participants, (SARS-CoV-2 seronegative at baseline), With Virologically-confirmed COVID-19 Disease | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase 2 and 3: Percentage of Participants With Solicited and Unsolicited Injection Site Reactions;Phase 2 and 3: Percentage of Participants With Solicited and Unsolicited Systemic Adverse Events (AEs);Phase 2 and 3: Percentage of Participants With Serious Adverse Events (SAEs);Phase 2 and 3: Percentage of Participants With Adverse Events of Special Interest (AESIs);Phase 3: Percentage of Participants With Death From All Causes;Phase 3: Percentage of Participants, (SARS-CoV-2 seronegative at baseline), With Non-Severe COVID-19 Disease;Phase 3: Percentage of Participants, (SARS-CoV-2 seronegative at baseline), With Severe COVID-19 Disease;Phase 3: Percentage of Participants, (SARS-CoV-2 seronegative at baseline), With Death From COVID-19 Disease;Phase 3: Percentage of Participants, (SARS-CoV-2 seropositive at baseline), With Virologically-Confirmed SARS-CoV-2 COVID-19 Disease ;Phase 3: Change From Baseline in Antigen-specific Cellular Immune Response Measured by IFN-gamma ELISpot Assay;Phase 3: Change From Baseline in Neutralizing Antibody Response Measured by a Pseudovirus-based Neutralization Assay | — |
Countries
Rwanda, Tunisia
Contacts
Public ContactInovio Call Center
Inovio
Outcome results
None listed