Covid-19 Living Data

Trial NCT04445194
Publication Yang S, Lancet, 2021
Dates: 22/06/2020 to 2020-07-03
Funding: Mixed (Nat’l Program on Key Research Project of China; Nat’l Science & Technology Major Projects of Drug Discovery, Strategic Priority Research Program of the Chinese Academy of Sciences; Anhui Zhifei Longcom Biopharmaceutical.)
Conflict of interest: Yes

Methods
	RCT
	Location : Multicenter / China Follow-up duration (months): 12
	•Placebo (aluminum hydroxide adjuvant) days 0, 30, 60 (n=10) •ZF2001 25 mcg per 0.5 mL days 0, 30, 60 (n=20) •ZF2001 50 mcg per 0.5 mL days 0, 30, 60 (n=20)
Inclusion criteria	Eligible participants were healthy men and nonpregnant women, 18 to 59 years of age. Healthy status, assessed during the screening period, was based on medical history and clinical laboratory findings, vital signs, and physical examination.
Exclusion criteria	A history of SARS or COVID-19, or were tested positive for SARS-CoV-2 exposure (by real-time PCR assay or enzyme-linked immunosorbent assay [ELISA]), or contacted with confirmed COVID-19 patients history of seizures or mental illness allergy to any ingredient in the vaccine acute febrile disease in 24 hours and digestive diseases in 7 days before enrollment congenital or acquired immune diseases serious chronic disease abnormal chest CT image positive test of HBV, HCV, HIV and syphilis tumor patients receipt of any blood products in the past 3 months receipt of any research medicines or vaccine in the past 3 month and being unable to comply with the study schedule
Interventions
	Intervention 3 IM doses of ZF2001 25 mcg 30 days apart 3 IM doses of ZF2001 50 mcg 30 days apart
	Control 3 IM doses of Adjuvant 30 days apart
Participants
	Randomized 50 participants
	Characteristics of participants Type of participants: Healthy volunteers N=50 30 males Children: 0 Pregnant women: 0 Immunocompromized patients: 0 Mean age: Age range: 21-58
	Description of participants Healthy SARS-CoV-2 infection-free adults aged 18-59 at 2 centers in China
Primary outcome
	In the register The number of adverse events after intramuscular injection
	In the report For the phase 1 trial, the primary outcome was the safety of the COVID-19 vaccine;Safety outcomes were the occurrence of adverse events between the first injection to 30 days after the final injection, including all adverse events, adverse events related to vaccination, adverse events at grade 3 and worse, and adverse events leading to withdrawal of participants.
Documents available	Protocol Yes. In English Statistical plan Yes Data-sharing stated: Yes, The data will be made available immediately after publication and finalisation of the complete clinical study report, for at least 6 months. Data accessibility: George F. Gao, CAS Key Laboratory of Pathogenic Microbiology and Immunology, Institute of Microbiology, Chinese Academy of Sciences, Beijing 10010, China. gaof@im.ac.cn
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, protocol, statistical analysis plan and supplementary material were used in data extraction and assessment of risk of bias. There were no substantive differences between the registry and the published article. The studyy achieved the pre-stated sample sizes. This trial was update on 15th April, 2021 after publication of the study report.