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OpenTrials
Completed

NCT Number: NCT07241975

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione IRCCS Policlinico San Matteo, SC Oncologia

Pavia, 27100, Italy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients ≥ 18 years diagnosed with and/or treated for solid tumors at the department of Oncologia of the Fondazione IRCCS Policlinico San Matteo
  • Prospective patients (or their or legal guardians) who have the ability to understand and be willing to sign a written informed consent document
  • 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

Treatment and study plan

Primary outcomes

  1. 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.

    Time frame: 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 outcomes

  1. To evaluate the mortality rate for COVID-19 disease

    Time frame: 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

  2. To evaluate the time to COVID 19 symptoms resolution

    Time frame: 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

  3. To evaluate the time to nasal swab viral clearance

    Time frame: 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

  4. To evaluate the time of the re-start of the oncological treatment

    Time frame: 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

  5. To evaluate the incidence of drug-related adverse events

    Time frame: 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

  6. To evaluate the incidence of long COVID symptoms according to WHO case definition

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Nov 21, 2025
Registry last updated
Nov 21, 2025

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.