Evidence map›Paper›PMID 40520909›Full record

ArticleContemporary clinical trials communications2025

Efficacy and safety of SARS-CoV-2 neutralizing antibody, SCTA01, in high-risk outpatients diagnosed with COVID-19: A Phase II clinical trial.

Jorge Diaz, Allex Fonseca, Lixin Yan, Dongfang Liu, Liangzhi Xie

Registry-linked trialAbstract read
In one paragraph

Article in Contemporary clinical trials communications, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04709328 (An Adaptive, Randomized, Double-blinded, Placebo-controlled Phase II/III Trial of Monoclonal Antibody SCTA01 Against SARS-CoV-2 in High-Risk Outpatients With COVID-19), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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.

NCT04709328 phase2 / phase3not yet recruitingnot on this map

An Adaptive, Randomized, Double-blinded, Placebo-controlled Phase II/III Trial of Monoclonal Antibody SCTA01 Against SARS-CoV-2 in High-Risk Outpatients With COVID-19 (MAOP3 Trial)

TypeinterventionalSponsorSinocelltech Ltd.Ran2021 to 2022Enrolled690ConditionsCOVID-19, SARS-CoV-2ArmsSCTA01, Placebo
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

5 authors.

Jorge DiazDoral Medical Research, LLC, Florida, USA.
Allex FonsecaCecor - Centro Oncologico de Roraima, Roraima, Brazil.
Lixin YanBeijing Engineering Research Center of Protein and Antibody, Sinocelltech Ltd., Beijing, China.
Dongfang LiuBeijing Engineering Research Center of Protein and Antibody, Sinocelltech Ltd., Beijing, China.
Liangzhi XieBeijing Engineering Research Center of Protein and Antibody, Sinocelltech Ltd., Beijing, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background/Objective: The neutralizing monoclonal antibody against SARS-CoV-2 is regarded as one of the most effective therapies for COVID-19. Methods: The primary endpoint was the proportion of patients who experienced COVID-19-related hospitalization (defined as at least 24 h of acute care) or death (all causes) by Day 29. Results: 109 patients were randomly assigned to and received SCTA01 750 mg (n = 25), 1500 mg (n = 29), 3000 mg (n = 30), or placebo (n = 25). Only two experienced COVID-19-related hospitalization by Day 29, one from the 750 mg group and the other from the 3000 mg group. Statistical analysis revealed no significant differences in viral load reduction ( Conclusions: There was no significant difference in clinical outcome between SCTA01 and placebo in the treatment of high-risk outpatients diagnosed with COVID-19, and it was well tolerated. CLINICAL TRIAL: The trial was registered at ClinicalTrial.gov (NCT04709328).

Indexed as

COVID-19Neutralizing antibodySARS-CoV-2

Identifiers

PMID40520909
PMCPMC12166818

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Registered trials

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.