Cancer Patients in Treatment Active Who Receive Early Out-patient Therapy Against SARS-CoV-2NCT07241975
Real-world Experience With the Available Outpatient COVID-19 Therapies in Patients With Cancer: an Ambispective Cohort Study
An observational study of Cancer Patients in Treatment Active Who Receive Early Out-patient Therapy Against SARS-CoV-2, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Patients in Treatment Active Who Receive Early Out-patient Therapy Against SARS-CoV-2
- How many people
- 112 participants
- Where
- 1 siteItaly
- Study dates
- 23 Aug 2022to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with solid tumors on active treatment who have COVID-19 infection and receive an early therapy are eligible. Patients admitted from January 2022 to December 2023 are candidate for the study. At the closure of the enrollment, we plan a further follow-up of 12 months.
Who may be able to join
- 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
Who cannot join
- Patients who are unable to understand informed consent document
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione IRCCS Policlinico San Matteo, SC Oncologia
Pavia, Pavia, 27100
About this 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (6)
To evaluate the mortality rate for COVID-19 disease
Measured: 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 COVID 19 symptoms resolution
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start23 Aug 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer Patients in Treatment Active Who Receive Early Out-patient Therapy Against SARS-CoV-2Studies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angioletta Lasagna, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07241975
- Sponsor's protocol ID
- CO_TER
- Status last verified
- Feb 2025
- First submitted
- 17 Nov 2025
- Last updated
- 21 Nov 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Experience With the Available Outpatient COVID-19 Therapies in Patients With Cancer: an Ambispective Cohort Study
- ClinicalTrials.gov ID
- NCT07241975
- Acronym / sponsor ID
- CO_TER
- Conditions
- Cancer Patients in Treatment Active Who Receive Early Out-patient Therapy Against SARS-CoV-2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 23 Aug 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with solid tumors on active treatment who have COVID-19 infection and receive an early therapy are eligible. Patients admitted from January 2022 to December 2023 are candidate for the study. At the closure of the enrollment, we plan a further follow-up of 12 months.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Patients who are unable to understand informed consent document
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
6 secondary outcomes
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer Patients in Treatment Active Who Receive Early Out-patient Therapy Against SARS-CoV-2, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.