Cancer & COVID 19Phase 2ONCOVIDNCT04341207
Epidemiology of SARS-CoV-2 and Mortality to Covid19 Disease in French Cancer Patients
A Phase 2 study testing Hydroxychloroquine and Azithromycin in people with Cancer & COVID 19, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
Trial summary
To determine the prevalence and the 3-months incidence of SARS-CoV-2 in cancer patients (Part A). To evaluate the Covid-19 disease-specific mortality rate in cancer patients treated by hydroxychloroquine and azithromycin (Part B). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer & COVID 19
- What is being tested?
- Hydroxychloroquine and Azithromycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 3 Apr 2020to Apr 2022
- Phase
- Phase 2
- 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
Who may be able to join
- All types of locally advanced and metastatic malignancy
- Male/female participants
- Age>18 y.o.
- Signed informed consent for participation in the study
- No restriction on Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) Performance Status
- Subject should not have received a prior systemic anti-viral treatment for Covid19 disease.
Who cannot join
- Patients with known hypersensitivity to hydroxychloroquine or chloroquine, azithromycin, erythromycin, or any other macrolide, ketolide or any of the excipients of the hydroxychloroquine and/or azithromycin-based specialty used.
- Severe hepatic impairment and patients with severe cholestasis.
- Patients with renal insufficiency with creatinine clearance < 40 mL/min.
- Combinations of drugs contraindicated in accordance with the approvals of the specialties used.
- Patients currently treated with Tamoxifen
- Patients already treated by hydroxychloroquine or azithromycin for Covid19 disease or currently treated with other antiviral drugs against coronavirus.
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- Patients with known contra-indication to treatment with the study drug, including retinopathy, G6PD deficiency, QT prolongation and severe hepato-cellular insufficiency.
- Patients post allogeneic hematopoietic stem cell transplantation are eligible to the Part B treatments but the potential toxic effects of hydroxychloroquin and azithromycin on hematopoietic stem cells should be taken into consideration by prescribers.
- Pregnant or breastfeeding women. Women of childbearing potential (WOCBP, as defined in appendix 2) should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Gustave Roussy
Villejuif, Val De Marne, 94800
Lisa DEROSA, MD, 0142114211 ext. +33, lisa.derosa@gustaveroussy.fr
Stefan MICHIELS, MD, 0142114211 ext. +33, stefan.michiels@gustaveroussy.fr
About this study
Official title: COVID 19 - Epidemiology of SARS-CoV-2 and Mortality to Covid19 Disease Upon Hydroxychloroquine and Azithromycin Therapy in French Cancer Patients
To determine the prevalence and the 3-months incidence of SARS-CoV-2 in cancer patients (Part A).
To evaluate the Covid-19 disease-specific mortality rate in cancer patients treated by hydroxychloroquine and azithromycin (Part B).
- Conditions
- Cancer & COVID 19
- Being tested
- Hydroxychloroquine, Azithromycin
- Medical subject headings
- Neoplasms, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxychloroquine 200 mg 3 times a day for 10 days
AzithromycinDrug
Azithromycin 500 mg on day 1 followed by 250 mg/day for 4 days
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Advanced Cancer Patients with SARS-CoV-2 positive test \& Covid19 symptoms Receives: Drug: Hydroxychloroquine; Drug: Azithromycin |
| Cohort 2 | No intervention | Advanced Cancer Patients with SARS-CoV-2 negative test \& Covid19 symptoms. Patients with a chest CT-scan compatible with Covid19 disease shall be treated in part B. |
| Cohort 3 | No intervention | Advanced Cancer Patients with SARS-CoV-2 positive or negative test \& no Covid19 symptoms |
| Cohort 4 | Experimental | Advanced Cancer Patients with SARS-CoV-2 positive test AND chest CT-scan compatible with Covid19 disease \& no Covid19 symptoms \& Pretreated or with frail conditions following the HCSP definition Receives: Drug: Hydroxychloroquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence and the 3-months incidence of SARS-CoV-2 in cancer patients
Measured: Up to 3 months
Covid-19 disease-specific mortality rate in cancer patients treated by hydroxychloroquine and azithromycin
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2020
- Study start3 Apr 2020
- Primary completionApr 2022 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer & COVID 19Studies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04341207
- Sponsor's protocol ID
- 2020-001250-21
- Other IDs
- 2020/3078
- Acronym
- ONCOVID
- Status last verified
- Apr 2020
- First submitted
- 8 Apr 2020
- Last updated
- 10 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID 19 - Epidemiology of SARS-CoV-2 and Mortality to Covid19 Disease Upon Hydroxychloroquine and Azithromycin Therapy in French Cancer Patients
- ClinicalTrials.gov ID
- NCT04341207
- Acronym / sponsor ID
- ONCOVID / 2020-001250-21
- Conditions
- Cancer & COVID 19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- 3 Apr 2020 (actual)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 10 Apr 2020 (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.
To determine the prevalence and the 3-months incidence of SARS-CoV-2 in cancer patients (Part A).
To evaluate the Covid-19 disease-specific mortality rate in cancer patients treated by hydroxychloroquine and azithromycin (Part B).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Hydroxychloroquine, Drug: AzithromycinAdvanced Cancer Patients with SARS-CoV-2 positive test \& Covid19 symptoms |
| Cohort 2 | No intervention | –Advanced Cancer Patients with SARS-CoV-2 negative test \& Covid19 symptoms. Patients with a chest CT-scan compatible with Covid19 disease shall be treated in part B. |
| Cohort 3 | No intervention | –Advanced Cancer Patients with SARS-CoV-2 positive or negative test \& no Covid19 symptoms |
| Cohort 4 | Experimental | Drug: HydroxychloroquineAdvanced Cancer Patients with SARS-CoV-2 positive test AND chest CT-scan compatible with Covid19 disease \& no Covid19 symptoms \& Pretreated or with frail conditions following the HCSP definition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- All types of locally advanced and metastatic malignancy
- Male/female participants
- Age>18 y.o.
- Signed informed consent for participation in the study
- No restriction on Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) Performance Status
Key exclusion criteria (9 listed)
- Patients with known hypersensitivity to hydroxychloroquine or chloroquine, azithromycin, erythromycin, or any other macrolide, ketolide or any of the excipients of the hydroxychloroquine and/or azithromycin-based specialty used.
- Severe hepatic impairment and patients with severe cholestasis.
- Patients with renal insufficiency with creatinine clearance < 40 mL/min.
- Combinations of drugs contraindicated in accordance with the approvals of the specialties used.
- Patients currently treated with Tamoxifen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydroxychloroquineHydroxychloroquine 200 mg 3 times a day for 10 days | Drug | Cohort 1, Cohort 4 |
| AzithromycinAzithromycin 500 mg on day 1 followed by 250 mg/day for 4 days | Drug | Cohort 1 |
Primary outcome
Prevalence and the 3-months incidence of SARS-CoV-2 in cancer patients
Time frame: Up to 3 months
Covid-19 disease-specific mortality rate in cancer patients treated by hydroxychloroquine and azithromycin
Time frame: Up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2020.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hydroxychloroquine and Azithromycin in people with Cancer & COVID 19, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
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 6 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 10 Apr 2020. 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 France. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lisa DEROSA, MD (0142114211 ext. +33, lisa.derosa@gustaveroussy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence and the 3-months incidence of SARS-CoV-2 in cancer patients (time frame: Up to 3 months). The study lists 2 primary outcomes in all. 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 10 Apr 2020.