Covid-19 Living Data

Trial NCT04642638
Publication Mammen Jr M, medRxiv, 2021
Dates: 2020-11-30 to 2021-02-05
Funding: Public/non profit (The US Department of Defense, Joint Program Executive Office)
Conflict of interest: Yes

Methods
	RCT
	Location : Multicenter / USA Follow-up duration (months): 13
	INO-4800 1.0 mg (n = 151) Placebo 1 (n = 50) INO-4800 2.0 mg (n = ) Placebo 2 (n = ) [INO-4800 2.0 mg and Placebo 2 arms combined = 200]
Inclusion criteria	Healthy adults aged 18 years or older able and willing to comply with all study procedures individuals 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 may be inconsistently used use of medically effective contraception with a failure rate of < 1% per year when used consistently, post-menopausal, or surgically sterile or have a partner who is sterile.
Exclusion criteria	Acute febrile illness with temperature higher than 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 [RTPCR]) test for SARS-CoV-2 at Screening 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 known history of uncontrolled HIV based on a CD4 count less than 200 cells/mm3 or a detectable viral load within the past 3 months currently participating or has participated in a study with an investigational product within 30 days preceding Day 0 previous receipt of an investigational vaccine for prevention or treatment of COVID-19, MERS, or 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 enrollment immunosuppression as a result of underlying illness or treatment lack of acceptable sites for ID injection and EP.
Interventions
	Intervention 2 intradermal doses of 1mg, 28 days apart 2 x 2 intradermal doses of 1mg, 28 days apart
	Control 2 intradermal doses of 1mg, 28 days apart2 x 2 intradermal doses of 1mg, 28 days apart
Participants
	Randomized 401 participants
	Characteristics of participants Type of participants: Healthy volunteers N=401 0 males Children: 0 Pregnant women: 0 Immunocompromized patients: 0 Mean age: NR Age range: NR
	Description of participants Healthy adult volunteers SARS-CoV-2 seronegative at high risk of infection at 16 locations in the USA.
Primary outcome
	In the register Change From Baseline in Antigen-specific Cellular Immune Response Measured by Interferon-gamma (IFN-γ) Enzyme-linked Immunospot (ELISpot) Assay ; Change From Baseline in Neutralizing Antibody Response Measured by a Pseudovirus-based Neutralization Assay [ Time Frame: Baseline up to Day 393 ]
	In the report The primary endpoints for the Phase 2 segment were immunologic in nature and comprised antigen-specific cellular immune responses measured by IFN-γ ELISpot assay and neutralizing antibody responses as measured by a pseudovirus-based neutralization assay.
Documents available	Protocol NR Statistical plan * Data-sharing stated: Yes, Anonymous IPD may be shared following or during the publication of summary data. Archival data may be accessed for up to 10 years following the end of the study. Data accessibility: Data dictionaries and all collected IPD will be stripped of identifiers and may be made available upon request. Corresponding author – Inovio Pharmaceuticals, 660W Germantown Pike, Suite #110, Plymouth Meeting, PA, 19462, USA. laurent.humeau@inovio.com
Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review	Some concerns
General comment	In addition to the pre-print article, the prospective trial registry was used in data extraction and assessment of risk of bias. Neither protocol nor statistical analysis plan was available. There were no substantive differences between the registry and the pre-print article in population, procedures, interventions or outcomes and the trial achieved its pre-stated sample size. The study reports preliminary findings from a trial in which follow up is ongoing.