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Multicenter real-world study to evaluate the antiviral effectiveness of small molecule agents for the treatment of COVID-19

Multicenter real-world study to evaluate the antiviral effectiveness of small molecule agents for the treatment of COVID-19

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300076420
Enrollment
Unknown
Registered
2023-10-08
Start date
2023-07-21
Completion date
Unknown
Last updated
2023-10-09

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

Conditions

COVID-19

Interventions

Nirmatrelvir/ritonavir group:N/A
Azvudine group:N/A
Deuremidevir Hydrobromide(VV116) group:N/A
Simnotrelvir/ritonavir (Xiannuoxin) group:N/A
Leritrelvir (Leruiling) group:N/A
Molnupiravir group:N/A
The untreated small-molecule drug (blank control) group:N/A

Sponsors

Beijing Youan Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: (1) All patients admitted due to COVID-19 should be included in the study screening. (2) Patients aged over 18 years who are confirmed to have SARS-CoV-2 infection by rapid antigen testing or RT-PCR test upon admission. (3) Patients who receive antiviral treatments such as Paxlovid, Molnupiravir, deute-rimevir hydrobromide, Xuenuoxin, Lairuitewei, and Azvudine during hospitalization, or have not received any antiviral drugs. (4) If the patient has received antiviral treatment within 24 hours before admission, the specific drug should be recorded and the original treatment plan should be continued. (5) Within 24 hours before admission or 48 hours after admission, the first COVID-19 RT-PCR test (including Ct value) was performed, and the Ct value is less than 35.

Exclusion criteria

Exclusion criteria: (1) The patient has only one RT-PCR test during hospitalization. (2) The patient has underlying disease status with high-risk progression factors or virus clearance delay, but cannot receive antiviral treatment due to special reasons. (e.g. organ transplant patients cannot receive antiviral drugs due to strong DDI between some immunosuppressive drugs and Lopinavir/Ritonavir; hemodialysis patients have not received antiviral treatment because they are not included in the treatment population according to the current drug instructions). (3) The patient enters other clinical studies of antiviral drugs for COVID-19 after admission. (4) The patient has received monoclonal antibody drugs for COVID-19 or entered clinical trials related to monoclonal antibody drugs within 3 months before admission. (5) The patient undergoes tracheal intubation within 24 hours after admission and cannot orally take COVID-19 antiviral drugs. (6) The patient has received antiviral treatment within 24 hours before admission, but changed the antiviral treatment plan after admission. (7) The patient has received antiviral treatment for more than 24 hours before admission (e.g. Paxlovid used for =3 times, Azvudine used for =2 times, Remdesivir used for =4 times). (8) The patient receives a two-drug combined antiviral treatment plan for COVID-19 during hospitalization.

Design outcomes

Primary

MeasureTime frame
Negative conversion time;

Secondary

MeasureTime frame
In-hospital mortality rate;ICU occupancy rate;

Countries

China

Contacts

Public ContactZhongjie Hu

Beijing Youan Hospital, Capital Medical University

yfcyt@139.com+86 135 0136 6613

Outcome results

None listed

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