Covid-19 Living Data

Trial NCT04510207, ChiCTR2000034780
Publication Al Kaabi N, JAMA, 2021
Dates: 2020-07-16 to 2020-12-20
Funding: Mixed (National Key Research and Development Project of China)
Conflict of interest: Yes

Methods
	RCT
	Location : Multicenter / United Arab Emirates, Bahrain Follow-up duration (months): 5
	Inactivated SARS-CoV-2 vaccine WIV04 (n=13,470) Inactivated SARS-CoV-2 vaccine HB02 (n=13,470) Placebo (alum adjuvant) (n=13,471)
Inclusion criteria	Age range: healthy people aged 18+ years old General good health as established by medical history and physical examination Women of childbearing age are not pregnant (negative urine pregnancy test), are not breastfeeding, do not have pregnancy plan within the three months after enrollment, and have already taken effective contraceptive measures two weeks before enrollment Participants are able and willing to complete the whole research procedure in about 14 months Participants have the ability to understand the research procedures, to sign the informed consent voluntarily after explanation, and can comply with the requirements of the clinical research program
Exclusion criteria	History of SARS-CoV, SARS-CoV-2 or MERS virus infection (identified through self-report or on-site inquiry) Those with fever (axillary temperature >37.0 °C), dry cough, fatigue, nasal obstruction, runny nose, sore throat, myalgia, diarrhea, shortness of breath, and dyspnea within 14 days before inoculation Axillary temperature ≥37.0 °C (or ear or forehead temperature ≥37.0 °C) before inoculation Those who have experienced severe allergic reactions (such as acute anaphylaxis, urticaria, eczema, dyspnea, neurovascular edema, or abdominal pain), or those who are allergic to the known gradients of COVID-19 inactivated vaccine Those with history or family history of convulsion, epilepsy, encephalopathy, or mental illness Those with congenital malformation, developmental disorder, genetic defect, or severe malnutrition, etc. Those with confirmed or suspected serious respiratory diseases, serious cardiovascular disease, severe liver or renal diseases, malignant tumors, uncontrolled hypertension (systolic blood pressure ≥150 mmHg, diastolic blood pressure ≥90 mmHg), diabetes complications, malignant tumors, or various acute or chronic diseases (acute attack stage) Those diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, or other autoimmune diseases Those with a history of abnormal coagulation (such as lack of coagulation factors or coagulation diseases) Those receiving anti-TB treatment Those receiving immune-enhancement or inhibitor treatment (p.o. or gtt.) over 14 days within 3 months (continuous oral or infusion for more than 14 days) Those receiving live-attenuated vaccines within one month before inoculation or other vaccines within 14 days before inoculation Those receiving blood products within 3 months before inoculation Those receiving other study drugs within 6 months before inoculation Those under other conditions not suitable for the clinical trial (evaluated by researchers)
Interventions
	Intervention 2 IM doses of 5 mcg, 21 days apart
	Control 2 IM doses of adjuvant, 21 days apart
Participants
	Randomized 40411 participants
	Characteristics of participants Type of participants: Healthy adults N=40411 22744 males Children: 0 Pregnant women: 0 Immunocompromized patients: 0 Mean age: NR Age range: NR
	Description of participants Healthy adults free of known COVID-19 or HIV infection at 3 centres in United Arab Emirates and Bahrain
Primary outcome
	In the register The incidence of COVID-19 cases after two-doses of vaccination - Time Frame: From 14 days after the second dose to 6 month after the second dose (NCT); Protective efficacy against COVID 19 14 days after the full course of vaccination (ChiCTR)
	In the report Laboratory-confirmed symptomatic COVID-19 cases that occurred at least 14 days after receipt of the second vaccine dose
Documents available	Protocol Yes. In English Statistical plan Yes Data-sharing stated: Yes, When available: beginning date: 12-20-2022, end date: 12-31-2027 Data accessibility: Data types: Deidentified participant data; How to access data: data can be accessed by writing to the sponsor and principal investigator with reasonable request: Dr. Xiaoming Yang (yangxiaoming@sinopharm.com); Who can access the data: Researchers whose proposed use of the data has been approved; Mechanisms of data availability: With investigator support, approval of the proposal and signed data access agreement
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 (ChiCTR posted 2020-07-18, recruitment start 2020-07-16, considered a prospective registration as explicitly reported as such and allowing for a delay between submission and final registration; NCT 2020-08-12), protocol, statistical analysis plan, and supplementary materials were used in data extraction and risk of bias assessment. There is no important change from the protocol in the population, procedures, interventions, or outcomes. At the time of the interim analysis (data set lock December 20, 2020, recruitment and randomization (n = 40411) had not yet reached the pre-specified target sample size ( n= 44488). Data collection for final analysis is pending.