Evidence map›Paper›PMID 35191746›Full record

Trial reportAntimicrobial agents and chemotherapy2022

Efficacy and Safety of SARS-CoV-2 Neutralizing Antibody JS016 in Hospitalized Chinese Patients with COVID-19: a Phase 2/3, Multicenter, Randomized, Open-Label, Controlled Trial.

Run Dong, Li Jiang, Ting Yang, Changsong Wang, Yi Zhang, Xu Chen, Jianfeng Xie, Yuanbin Guo, Li Weng, Yan Kang and 4 more

Open access · hybridAbstract readClinical Trial, Phase IIClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Antimicrobial agents and chemotherapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
0.8field-weighted citation impact, top 29% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  1. SARS-CoV-2-neutralising monoclonal antibodies to prevent COVID-19.The Cochrane database of systematic reviews · 2022
    Pooled it
  2. Review
  3. Review
  4. Article
  5. Review
  6. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 6 institutions in 1 country.

Run Dong *Medical Intensive Care Unit, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences, Beijing, People's Republic of China.
Li Jiang *Department of Critical Care Medicine, Xuanwu Hospital, Capital Medical University, Beijing, People's Republic of China.
Ting Yang *Medical Intensive Care Unit, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences, Beijing, People's Republic of China.
Changsong WangIntensive Care Unit, Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, People's Republic of China.
Yi ZhangDepartment of Critical Care Medicine, West China Hospital, Sichuan University, Chengdu, Sichuan, People's Republic of China.
Xu ChenIntensive Care Unit, The First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, People's Republic of China.
Jianfeng XieDepartment of Critical Care Medicine, Zhongda Hospital, Southeast University, Nanjing, Jiangsu, People's Republic of China.
Yuanbin GuoIntensive Care Unit, Shijiazhuang People's Hospital, Shijiangzhuang, Hebei, People's Republic of China.
Li WengMedical Intensive Care Unit, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences, Beijing, People's Republic of China.ORCID 0000-0003-0403-0752
Yan KangDepartment of Critical Care Medicine, West China Hospital, Sichuan University, Chengdu, Sichuan, People's Republic of China.
Kaijiang YuIntensive Care Unit, The First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, People's Republic of China.
Haibo QiuDepartment of Critical Care Medicine, Zhongda Hospital, Southeast University, Nanjing, Jiangsu, People's Republic of China.
Bin DuMedical Intensive Care Unit, State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences, Beijing, People's Republic of China.ORCID 0000-0001-6237-2895
China Critical Care Clinical Trials Group (CCCCTG)
Chinese Academy of Medical Sciences & Peking Union Medical College · CNHarbin Medical University · CNSichuan University · CNZhongda Hospital Southeast University · CNCapital Medical University · CNFirst Hospital of Shijiazhuang · CN

Funding

Beijing Medical and Health Foundation B17245-043Ministry of Science and Technology of the People's Republic of China (MOST) 2021YFC0863100
6 · The paper itself

Abstract

Recombinant human severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) monoclonal antibody JS016 showed neutralizing and therapeutic effects in preclinical studies. The clinical efficacy and safety of the therapy needed to be evaluated. In this phase 2/3, multicenter, randomized, open-label, controlled trial, hospitalized patients with moderate or severe coronavirus disease 2019 (COVID-19) were randomly assigned in a 1:1 ratio to receive standard care or standard care plus a single intravenous infusion of JS016. The primary outcome was a six-level ordinal scale of clinical status on day 28 since randomization. Secondary outcomes include adverse events, 28-day mortality, ventilator-free days within 28 days, length of hospital stay, and negative conversion rate of SARS-CoV-2 nucleic acid on day 14. A total of 199 patients were randomized, and 197 (99 in the JS016 group and 98 in the control group) were analyzed. Most patients, 95 (96%) in the JS016 group and 97 (99%) in the control group were in the best category on day 28 since randomization. The odds ratio of being in a better clinical status was 0.31 (95% confidence interval [CI], 0.03 to 3.19;

Indexed as

COVID-19 Drug TreatmentAntibodies, Monoclonal, HumanizedAntibodies, NeutralizingChinaHumansSARS-CoV-2Treatment OutcomeAntibodies, Monoclonal, HumanizedAntibodies, NeutralizingetesevimabCOVID-19JS016neutralizing antibodiesSARS-CoV-2

Identifiers

PMID35191746
PMCPMC8923168
OpenAlexW4212798376

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.