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Active, Not Recruiting

NCT Number: NCT06142201

A Real-World Study of JT001 for COVID-19

Real-world disease outcomes and safety in patients with mild to moderate COVID-19 treated with JT001

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking university first hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years old.
  • The novel coronavirus infection (COVID-19) meets at least one of the following five criteria:
  • Diagnosis of novel coronavirus infection; 2) Diagnosed with novel coronavirus pneumonia; 3) The novel coronavirus nucleic acid test is positive; 4) Test positive for novel coronavirus antigen; 5) Culture positive for novel coronavirus.
  • Patients who have not developed severe COVID-19 or died within 28 days of COVID-19 diagnosis, or who have developed severe COVID-19 or died within 28 days of COVID-19 diagnosis, were treated with deuterimodivir hydrobromide tablets or were not treated with anti-novel coronavirus before disease progression.

Exclusion criteria

· Patients who have not developed severe COVID-19 or died within 28 days of COVID-19 diagnosis, or those who have developed severe COVID-19 or died within 28 days of COVID-19 diagnosis, received the following anti-novel coronavirus treatments before disease progression, including: Nematavir tablet/Ritonavir tablet, Azvudine tablet, Monoravir capsule, Zenotavir tablet/Ritonavir tablet, Leritvir tablet, Ambavirzumab/Romisivir injection, human immunoglobulin for COVID-19 or convalescent plasma for COVID-19 survivors.

Treatment and study plan

JT001

Drug

oral administration

Other names: DeuremidevirHydrobromideTablets

Primary outcomes

  1. Incidence of COVID-19 disease progression (severe COVID-19 or all-cause death) by day 28

    Time frame: Within 28 days

    Incidence of COVID-19 disease progression (severe COVID-19 or death from any cause) at day 28 from COVID-19 diagnosis. According to the diagnosis of severe COVID-19 and indicators meeting the diagnostic definition of severe COVID-19, the evaluation and analysis were performed.

Secondary outcomes

  1. Incidence of the following COVID-19 disease progression events by day 28

    Time frame: Within 28 days

    Severe COVID-19 or all-cause death in patients with high-risk factors,Elderly patients (≥65 years) with severe COVID-19 or all-cause death,All enrolled patients had severe COVID-19,All enrolled patients died from all causes,COVID-19 related hospitalizations in non-hospitalized patients,Hospitalized patients with severe COVID-19 or all-cause death.

  2. Incidence of severe Covid-19-related events up to day 28

    Time frame: Within 28 days

    Incidence of severe Covid-19-related events up to day 28,Respiratory rate ≥30 times/min, Oxygen saturation (SpO2) ≤93% ,Partial oxygen pressure (PaO2)/Oxygen concentration (FiO2) ≤300mmHg,Lung imaging showed significant lesion progression > 50% within 24 to 48 hours,Mechanical ventilation o Respiratory failure and mechanical ventilation,Shock,Stay in ICU,Organ failure and admission to ICU.

  3. The incidence of all aes and abnormal laboratory changes on day 28, etc

    Time frame: Within 28 days

    The incidence of all aes and abnormal laboratory changes on day 28, etc

Other outcomes

  1. Changes of SARS-CoV-2 through Day 28

    Time frame: Within 28 days

    Percentage of patients who achieve SARS-CoV-2 nucleic acid negative through Day 28，Change of SARS-CoV-2 viral load from baseline to Day 28

Sponsors and collaborators

Lead sponsor

Shanghai Vinnerna Biosciences Co., Ltd.

Industry

Registry information

Official study title

A Real-world Study：Disease Outcome and Safety of JT001 in Patients With Coronavirus Disease 2019 (COVID-19)

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 21, 2023
Registry last updated
Aug 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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