Changes to trial information |
Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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Intervention |
Intervention List |
12/10/2021 |
This is the device used along with the intervention; the group is assigned to the intervention, not the device. |
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Experimental Group, Device CELLECTRA 2000, Once on Day 0 and Day 28., Day 0 and Day 28, Electroporation (EP) using the CELLECTRA® 2000 device will be administered following ID delivery of INO-4800 on Day 0 and Day 28., 0, |
Section Name
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Field Name
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Date
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Old Value
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Updated Value
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Intervention |
Intervention List |
12/10/2021 |
This is the device used along with the intervention; the group is assigned to the intervention, not the device. |
Experimental Group, Device CELLECTRA 2000, Once on Day 0 and Day 28., Day 0 and Day 28, EP using the CELLECTRA® 2000 device will be administered following ID delivery of sterile saline sodium citrate (SSC) buffer (SSC-0001) on Day 0 and Day 28., 2372, |
Experimental Group, Device CELLECTRA 2000, Once on Day 0 and Day 28., Day 0 and Day 28, EP using the CELLECTRA® 2000 device will be administered following ID delivery of sterile saline sodium citrate (SSC) buffer (SSC-0001) on Day 0 and Day 28., 0, |
Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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Trial Information |
Anticipated trial start date |
12/10/2021 |
Anticipated start of trial pending ethics approval. |
01 Nov 2020 |
01 Dec 2021 |
Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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Trial Information |
Actual trial start date |
12/10/2021 |
Trial was started in the US but is pending ethics approval for PACTR. |
20 Nov 2020 |
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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Intervention |
Intervention List |
13/10/2021 |
Update intervention name. |
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Experimental Group, INO 4800 Dose , Once on Day 0 and Day 28., Day 0 and Day 28, INO-4800 will be administered intradermal injection on Day 0 and Day 28. Electroporation (EP) using the CELLECTRA® 2000 device will be administered following ID delivery of INO-4800 on Day 0 and Day 28. , 4744, |
Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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Intervention |
Intervention List |
13/10/2021 |
Update intervention. |
Control Group, Placebo , Once on Day 0 and Day 28., Day 0 and Day 28, Sterile saline sodium citrate (SSC) buffer (SSC-0001) will be administered ID on Day 0 and Day 28.
, 2372, Placebo |
Control Group, Placebo , Once on Day 0 and Day 28., Day 0 and Day 28, Sterile saline sodium citrate (SSC) buffer (SSC-0001) will be administered ID on Day 0 and Day 28. EP using the CELLECTRA® 2000 device will be administered following ID delivery of sterile saline sodium citrate (SSC) buffer (SSC-0001) on Day 0 and Day 28.
, 2372, Placebo |
Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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Trial Information |
Actual trial start date |
31/01/2022 |
Updated start date |
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30 Nov 2020 |
Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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Trial Information |
Recruitment status |
31/01/2022 |
Study has started |
Active, not recruiting |
Recruiting |
Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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Trial Information |
Anticipated date of last follow up |
07/06/2022 |
Updated per amendment |
31 Jan 2023 |
28 Feb 2023 |
Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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Trial Information |
Recruitment status |
07/06/2022 |
Updated per amendment |
Recruiting |
Active, not recruiting |
Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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Trial Information |
Recruitment status |
07/06/2022 |
Updated status due to study changes. |
Active, not recruiting |
Recruiting |
Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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Trial Information |
Recruitment status |
07/06/2022 |
Updated status due to study changes. |
Recruiting |
Active, not recruiting |
Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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Eligibility |
Exclusion criteria |
07/06/2022 |
added missing text |
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 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 |
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.
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Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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Outcome |
OutCome List |
07/06/2022 |
Updates to outcome measure text |
Secondary Outcome, Phase 3: Percentage of Participants, (SARS-CoV-2 seronegative at baseline), With Virologically-Confirmed SARS-CoV-2 COVID-19 Disease, From 14 days after completion of the 2-dose regimen up to 12 months post-dose 2 Day 42 up to Day 393 |
Secondary Outcome, Phase 3: Percentage of Participants, (SARS-CoV-2 seropositive at baseline), With Virologically-Confirmed SARS-CoV-2 COVID-19 Disease
, From 14 days after completion of the 2-dose regimen up to 12 months post-dose 2 Day 42 up to Day 393 |
Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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Trial Information |
Recruitment status |
07/06/2022 |
Study status update |
Active, not recruiting |
Recruiting |
Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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Trial Information |
Recruitment status |
07/06/2022 |
Study status update |
Recruiting |
Active, not recruiting |
Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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Trial Information |
Recruitment status |
10/06/2022 |
Study cancelled in these countries |
Active, not recruiting |
Withdrawn |
Section Name
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Field Name
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Date
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Reason
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Old Value
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Updated Value
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Trial Information |
Final no of participants |
10/06/2022 |
Study withdrawn |
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0 |