Evidence map›Paper›PMID 34491805›Full record

Trial reportAntimicrobial agents and chemotherapy2021

Safety, Tolerability, Pharmacokinetics, and Immunogenicity of a Monoclonal Antibody (SCTA01) Targeting SARS-CoV-2 in Healthy Adults: a Randomized, Double-Blind, Placebo-Controlled, Phase I Study.

Yinjuan Li, Lu Qi, Haihong Bai, Chunyun Sun, Shuping Xu, Yu Wang, Chunyu Han, Yan Li, Long Liu, Xiaoqiang Cheng and 10 more

Abstract readClinical Trial, Phase IRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Antimicrobial agents and chemotherapy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
–field-weighted citation impact
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

12 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Review
  6. Review
  7. Article
  8. Immune-based therapeutic approaches in COVID-19.Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie · 2022
    Review
  9. Review
  10. Article
  11. Review
  12. 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

20 authors.

Yinjuan Li *Department of Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.
Lu Qi *Department of Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.
Haihong Bai *Department of Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.
Chunyun SunSinocelltech Ltd., Beijing, China.
Shuping XuSinocelltech Ltd., Beijing, China.
Yu WangDepartment of Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.
Chunyu HanDepartment of Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.
Yan LiDepartment of Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.
Long LiuDepartment of Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.
Xiaoqiang ChengDepartment of Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.
Ju LiuDepartment of Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.
Chunpu LeiDepartment of Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.
Yuanxu TongDepartment of Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.
Mingli SunDepartment of Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.
Lixin YanSinocelltech Ltd., Beijing, China.
Weiqiu ChenSinocelltech Ltd., Beijing, China.
Xisheng LiuSinocelltech Ltd., Beijing, China.
Qing LiuSinocelltech Ltd., Beijing, China.
Liangzhi XieSinocelltech Ltd., Beijing, China.
Xinghe WangDepartment of Phase I Clinical Trial Center, Beijing Shijitan Hospital, Capital Medical University, Beijing, China.ORCID 0000-0002-4197-8545

Funding

Beijing Municipal Science and Technology Project Z201100005420017National Science and Technology Major Project 2018ZX09711003
6 · The paper itself

Abstract

SCTA01 is a novel monoclonal antibody with promising prophylactic and therapeutic potential for COVID-19. This study aimed to evaluate the safety, tolerability, pharmacokinetics (PK) and immunogenicity of SCTA01 in healthy adults. This was a randomized, double-blind, placebo-controlled, dose escalation phase I clinical trial. Healthy adults were randomly assigned to cohort 1 (

Indexed as

COVID-19SARS-CoV-2AdultAntibodies, MonoclonalAntibodies, ViralDouble-Blind MethodHumansAntibodies, MonoclonalAntibodies, ViralCOVID-19monoclonal antibodypharmacokineticssafetySARS-CoV-2

Identifiers

PMID34491805
PMCPMC8522782

What OpenQuestion holds

Textmetadata
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.