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A study to evaluating the efficacy and safety of KFX in the treatment of severe novel coronavirus pneumonia (COVID-19) patients

A study to evaluating the efficacy and safety of KFX in the treatment of severe novel coronavirus pneumonia (COVID-19) patients

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300067485
Enrollment
Unknown
Registered
2023-01-09
Start date
2023-01-09
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

coronavirus pneumonia (COVID-19)

Interventions

KFX:Best treatment+Kangfuxin liquid20ml,tid
palcebo:Best treatment+placebo20ml,tid

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
14 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1) Age 20-80, male or female; 2) positive SARS-CoV-2 test result within 3 weeks; 3) HRCT meeting the manifestations of viral pneumonia (judged by the investigator) and meeting any of the following criteria: Shortness of breath, respiratory rate (RR) =30 times/min; At rest, SpO2 50% within 24~48 hours; PaO2/FiO2 <=300mmHg(1mmHg=0.133kPa) 4)The patient must be able to fully understand the informed consent form and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1)Patients who have known allergies to any of the components used in the formulation of the interventions; 2)Patients with a history of asthma or ongoing asthma attacks; 3)Patients with critical novel coronavirus pneumonia (COVID-19); 4)Female who is pregnant or breast-feeding or plan to be pregnant within this study period; 5)The investigator considers it inappropriate to participate in the study .

Design outcomes

Primary

MeasureTime frame
Interval and proportion of randomization to clinical improvement;

Secondary

MeasureTime frame
Proportion of subjects whose disease progressed to critical illness at day 14 and 28;All-cause mortality of subjects at day 28;the time interval between randomization and discharge; the ratio of NIAID - OS score from baseline to improve two or more subjects at day 28;Proportion of subjects with HRCT showing significant absorption of lung inflammation during treatment and/or at EOT;the rate of AE ,SAE;Changes in vital signs, physical examination, laboratory examination, 12-lead electrocardiogram, etc;

Countries

China

Contacts

Public ContactWei min Li

West China Hospital, Sichuan University

weimi003@yahoo.com18980606625

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026