Covid-19 Living Data

Trial IRCT20150303021315N24 ; NCT05005559
Publication Tabarsi P, Clin Microbiol Infect, 2022
Dates: 2021-08-07 to 2021-09-30
Funding: Private (CinnaGen Co)
Conflict of interest: Yes

Methods
	RCT
	Location : Single center / Iran Follow-up duration (months): 6.7
	25 mcg SpikoGen (n = 12657) Placebo (n = 4219)
Inclusion criteria	Immunocompetent adults aged 18-50 years with stable medical conditions (not being hospitalized within 3 months before the screening visit)
Exclusion criteria	Pregnant or lactating women Active infection with clinical signs of SARS-CoV-2 during screening or contact with a confirmed COVID-19 case within the last 14 days Any progressive or severe neurological disorder, seizures, or a history of Guillain-Barre syndrome History of Down syndrome, Chronic Obstructive pulmonary diseases, Cystic fibrosis, Pulmonary artery hypertension, BMI greater than 40 kg/m2 End stage renal diseases, participants with uncontrolled asthma, hypertension, or diabetes mellitus Receiving immunosuppressive medications Participants who could get a COVID-19 vaccine within 2 months after the study enrollment based on the national COVID-19 immunization program in Iran (at the time of protocol approval, Iran FDA believed that authorized COVID-19 vaccines will be available in Iran in the near future and people who had a priority for injection could get the vaccine. We thought patients with risk factors for severe COVID-19 and those who might get the vaccine based on their professions or conditions including healthcare workers should not be enrolled.) History of severe adverse reactions (e.g., anaphylaxis) to any components of the vaccine under study 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 vaccines 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 and 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 ml of blood or blood products in the 28 days before screening Special circumstances that, in the researcher’s view, may increase the risk of participating in the study or interfere with the evaluation of the initial objectives of the trial.
Interventions
	Intervention 2 IM doses of 25 mcg SpikoGen, 21 days apart
	Control 2 IM doses of placebo, 21 days apart
Participants
	Randomized 16876 participants
	Characteristics of participants Type of participants: Adults with stable co-morbidities N=16876 9551 males Children: 0 Pregnant women: 0 Immunocompromized patients: 0 Mean age: Age range: NR
	Description of participants Immunocompetent adults with stable medical conditions at a single center in Iran.
Primary outcome
	In the register 1) Evaluation of COVID-19 incidence 14 days after the second dose - Participants must have at least two of the following systemic symptoms: fever (38 ° C), chills, myalgia, headache, sore throat, nausea, vomiting, diarrhea, nasal discharge, new olfactory disorder, "or" the participant must have experienced at least one of the following respiratory signs and symptoms: cough, shortness of breath, clinical or radiographic evidence of pneumonia "and" at least one positive PCR test for SARS-CoV-2 ; 2) Evaluation of severe COVID-19 incidence 14 days after the second dose - If the patient has any of the following symptoms, is classified as severe type of COVID-19: respiratory rate ≥30 per minute. Heart rate ≥125 per minute. Oxygen saturation ≤93% in ambient air. Respiratory failure or acute respiratory distress syndrome (ARDS) or (requires high-flow oxygen or non-invasive or mechanical ventilation or ECMO) Evidence of shock (systolic blood pressure <90 mm Hg, diastolic blood pressure <60 mm Hg) or the need for vasopressors). Acute renal, hepatic or neurological dysfunction. Hospitalization in the intensive care unit or death.
	In the report Occurrence of symptomatic COVID-19 starting from 14 days after the second dose. Primary events were defined as participants with at least one positive Polymerase chain reaction (PCR) test and any two or more of fever, chills, myalgia, headache, sore throat, nausea, vomiting, diarrhea, rhinorrhea, new-onset anosmia or ageusia or at least one positive PCR test and any one or more of the following respiratory signs and symptoms: cough, shortness of breath, and clinical or radiographic evidence of pneumonia starting 2 weeks after the second dose.
Documents available	Protocol NR Statistical plan * Data-sharing stated: NR Data accessibility: Saghar Barati - E-mail address: 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. One primary outcome in the article reflect that in the registry (symptomatic COVID-19). The second primary outcome in the registry (severe COVID-19) is described as secondary in the article. The trial (n = 16876) achieved its target sample size (n = 16876).