Real-world Experience With the Available Outpatient COVID-19 Therapies in Patients With Cancer: an Ambispective Cohort Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07241975

Enrollment

112

Registered

2025-11-21

Start date

2022-08-23

Completion date

2024-12-31

Last updated

2025-11-21

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

Conditions

Cancer Patients in Treatment Active Who Receive Early Out-patient Therapy Against SARS-CoV-2

Brief summary

The real-life efficacy of early antiviral therapies in cancer patients with COVID-19 is largely uncharacterized. From these unresolved issues, it is therefore necessary to fill these knowledge gaps by assessing the efficacy and safety of these therapies in combination with anti-cancer therapies.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Patients ≥ 18 years diagnosed with and/or treated for solid tumors at the department of Oncologia of the Fondazione IRCCS Policlinico San Matteo 2. Prospective patients (or their or legal guardians) who have the ability to understand and be willing to sign a written informed consent document 3. Retrospective patients who have signed the institutional document allowing the use of their data for research on their disease

Exclusion criteria

* Patients who are unable to understand informed consent document

Design outcomes

Primary

Measure	Time frame
evaluate the rate of hospitalization for COVID-19 disease within 14 days in the patients with cancer using COVID-19 early therapies as per indication.	Data will be collected at T0 = start of COVID-19 therapy T1 = seven days after T0 T2 = 2 weeks after T0 T3 = one month after T0 T4 = + 3 months after T0 T5 = + 6 months after T0 T6 = + 12 months after T0

Secondary

Measure	Time frame
To evaluate the time to COVID 19 symptoms resolution	Data will be collected at T0 = start of COVID-19 therapy T1 = seven days after T0 T2 = 2 weeks after T0 T3 = one month after T0 T4 = + 3 months after T0 T5 = + 6 months after T0 T6 = + 12 months after T0
To evaluate the time to nasal swab viral clearance	Data will be collected at T0 = start of COVID-19 therapy T1 = seven days after T0 T2 = 2 weeks after T0 T3 = one month after T0 T4 = + 3 months after T0 T5 = + 6 months after T0 T6 = + 12 months after T0
To evaluate the mortality rate for COVID-19 disease	Data will be collected at T0 = start of COVID-19 therapy T1 = seven days after T0 T2 = 2 weeks after T0 T3 = one month after T0 T4 = + 3 months after T0 T5 = + 6 months after T0 T6 = + 12 months after T0
To evaluate the incidence of drug-related adverse events	Data will be collected at T0 = start of COVID-19 therapy T1 = seven days after T0 T2 = 2 weeks after T0 T3 = one month after T0 T4 = + 3 months after T0 T5 = + 6 months after T0 T6 = + 12 months after T0
To evaluate the incidence of long COVID symptoms according to WHO case definition	Data will be collected at T0 = start of COVID-19 therapy T1 = seven days after T0 T2 = 2 weeks after T0 T3 = one month after T0 T4 = + 3 months after T0 T5 = + 6 months after T0 T6 = + 12 months after T0
To evaluate the time of the re-start of the oncological treatment	Data will be collected at T0 = start of COVID-19 therapy T1 = seven days after T0 T2 = 2 weeks after T0 T3 = one month after T0 T4 = + 3 months after T0 T5 = + 6 months after T0 T6 = + 12 months after T0

Countries

Italy

Outcome results