Covid-19 Living Data

Trial IRCT20150303021315N23 ; NCT04944368
Publication Tabarsi P, CMI, 2022

Funding: Private (CinnaGen Company)
Conflict of interest: Yes

Methods
	RCT
	Location : Single center / Iran Follow-up duration (months): 6.6
	SpikoGen (n = 311) Placebo (n = 89)
Inclusion criteria	Healthy adults (or adults with stable medical conditions) aged 18 years and above including patients who had recovered from previous SARS-CoV-2 infection.
Exclusion criteria	Women who were pregnant or lactating (or who planned to be pregnant within the trial) active infection with clinical symptoms of SARS-CoV-2 during screening or contact with a confirmed COVID-19 case within the last 14 days participants who could get a COVID-19 vaccine within 2 months after the study enrollment date based on the national COVID-19 immunization program in Iran any progressive or severe neurological disorder, seizures, or a history of Guillain-Barre syndrome receiving immunosuppressive medications the history of severe adverse reactions (e.g., anaphylaxis) to any components of the vaccine being studied administration of any other research product within 30 days before screening or intention to participate in another clinical study at the time of this study previous vaccination with any type of SARS-CoV-2 vaccine previous vaccination with any other authorized vaccine within 28 days before screening (or the intention to receive such a vaccine within 14 days after the second vaccination) suffering from a known bleeding disorder who may have problems with intramuscular injection administration of (or the intention to receive) any blood, plasma, or immunoglobulin products within 90 days before screening donation of more than or equal to 450 milliliters of blood or blood products within the 28 days before screening any special circumstances that, in the researcher’s view, may increase the risk of participating in the study or interfere with the evaluation of the objectives of the study.
Interventions
	Intervention 2 IM doses of 25 mcg SpikoGen, 21 days apart
	Control 2 IM doses of placebo, 21 days apart
Participants
	Randomized 400 participants
	Characteristics of participants Type of participants: Adults N=400 215 males Children: 0 Pregnant women: 0 Immunocompromized patients: 0 Mean age: Age range: NR
	Description of participants Healthy adults or those with stable medical conditions, with or without prior COVID-19 infection, at a single center in Iran.
Primary outcome
	In the register 1) Incidence of solicited adverse events [Time Frame: For 7 days after each dose]: Injection site pain, erythema, swelling, and induration, axillary swelling or tenderness ipsilateral to the side of injection, fever (oral temperature), headache, fatigue, myalgia, arthralgia, nausea, vomiting, and chills, as reported by the study participants on electronic diaries, and as defined using system organ classes and preferred terms of the Medical Dictionary for Regulatory Activities (MedDRA). 2) Incidence of unsolicited adverse events [Time Frame: For 28 days after each dose]: As reported by the study participants on electronic diaries, and as defined using system organ classes and preferred terms of the Medical Dictionary for Regulatory Activities (MedDRA). 3) Percentage of participants with seroconversion for S1 binding IgG antibodies after the first injection [Time Frame: 21 days after the first dose (on the day of the second dose)]: As measured by ELISA. 4) Percentage of participants with seroconversion for S1 binding IgG antibodies after the second injection [Time Frame: 14 days after the second dose]: As measured by ELISA. 5) Change in geometric mean concentration (GMC) for S1 binding IgG antibodies from baseline to 21 days after the first injection [Time Frame: On the day of the first dose and 21 days after the first dose (on the day of the second dose)]: As measured by ELISA. 6) Change in geometric mean concentration (GMC) for S1 binding IgG antibodies from baseline to 14 days after the second injection [Time Frame: On the day of the first dose and 14 days after the second dose]: As measured by ELISA.
	In the report 1) The primary safety outcomes were the incidence of local and systemic solicited adverse events for 7 days after each dose and the incidence of unsolicited adverse events up to 28 days after the second dose. 2) The primary immunogenicity outcomes were seroconversion rate against S1 protein and the geometric mean concentration (GMC) of S1 IgG in the two groups on days 21 and 35.
Documents available	Protocol NR Statistical plan * Data-sharing stated: Yes Data accessibility: Anonymous participant data will be available upon a reasonable request to the corresponding author. Saghar Barati - Barati.S@orchidpharmed.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 published article, the trial registries and supplementary appendices were used in data extraction and assessment of risk of bias. Neither protocol nor statistical analysis plan was available. here were no important differences between registry and published report in population, procedures, interventions or outcomes. The trial (n = 400) achieved its target sample size (n = 400).