COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04642638

Dr. Ning Jiang

Not reported

2020-11-24

Terminated

RCT

Randomized

Sequential assignment

Blind label

multi-center

Prevention

key 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). key

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 (e.g., cough, shortness of breath, sore throat). 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 human immunodeficiency virus (hiv) based on clusters of differentiation (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.

4

Inovio Pharmaceuticals

18

100

Colombia;Mexico;United States

Close contacts to covid patients

N/A

1307

Phase 2: Change From Baseline in Antigen-specific Cellular Immune Response Measured by Interferon-gamma (IFN-γ) 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

None

Phase 2/Phase 3

[{"arm_notes": "1mg;1 EP using the CELLECTRA\u00ae 2000", "treatment_id": 653, "treatment_name": "Ino-4800", "treatment_type": "Dna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "1mg;2 EP using the CELLECTRA\u00ae 2000", "treatment_id": 653, "treatment_name": "Ino-4800", "treatment_type": "Dna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "1mg;1 or 2 EP using the CELLECTRA\u00ae 2000", "treatment_id": 653, "treatment_name": "Ino-4800", "treatment_type": "Dna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "two ID injections of placebo followed by EP using the CELLECTRA\u00ae 2000 device on Day 0 and Day 28.", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]