Time to Initiated Antitumor Therapy for Tumor Patients With COVID19 Infection

Recruiting

• Conditions: COVID-19; Tumor

• Registration Number: NCT06006845
• Lead Sponsor: The Seventh Affiliated Hospital of Sun Yat-sen University

Brief Summary

The goal of this observational study is to study the safety of initiation of antitumor therapy early after nucleic acid test turn negativity in tumor patients infected with COVID-19. The main questions aims to answer are:

* Whether initiation of antitumor therapy early after nucleic acid test turn negativity in tumor patients infected with COVID-19 increases adverse events related to antitumor therapy.

* Whether initiation of antitumor therapy early after nucleic acid test turn negativity in tumor patients infected with COVID-19 increases risk of re-infection of COVID-19.

* How initiation of antitumor therapy early after nucleic acid test turn negativity in tumor patients infected with COVID-19 affects QoL of tumor patients

Participants will be asked to answer the question about:

* the severity and duration of COVID-19 symptoms

* the date of diagnosis of COVID-19

* the date of negative nucleic acid test

* the QoL of life before infection with COVID-19, during infection of COVID-19, after nucleic acid test negativity and receiving antitumor therapy

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-01
• Primary Completion: 2023-02-01
• Status Verified: 2023-08
• Study First Submitted: 2023-08-22
• Study First Submitted QC: 2023-08-22
• Last Update Submitted: 2023-08-22
• Study First Posted: 2023-08-23
• Last Update Posted: 2023-08-23
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Tumor patients diagnosed with COVID-19 infection at our center from December 1, 2022 to May 31.
• COVID-19 was confirmed by antigen testing or nucleic acid testing.
• Tumor was confirmed by pathology.
• Patients received systemic antitumor therapy after infected with COVID-19.

Exclusion Criteria

• COVID-19 was not confirmed by antigen testing or nucleic acid testing
• Tumor was not confirmed by pathology
• Patients did not receive systemic antitumor therapy
• Patients died before receiving systemic antitumor therapy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Re-infection of COVID-19	28 days after antitumor therapy	Antigen testing or nucleic acid testing positive for COVID-19
Incidence of adverse events after antitumor therapy	28 days after antitumor therapy	Incidence of adverse events after antitumor therapy, including hematologic toxicity,gastrointestinal adverse event, hepatobiliary adverse events, etc.

Secondary Outcome Measures

Name	Time	Method
Clinical manifestations of COVID-19 in tumor patients	Until nucleic acid testing turn negative	Symptoms and lab abnormality of COVID-19 in tumor patients

Trial Locations

Locations (1)

Seventh Affiliated Hospital, Sun Yat-sen University; 🇨🇳 Shenzhen, Guangdong, China