COVID-19Phase 2NCT04381988
A Study of Hydroxychloroquine vs Placebo to Prevent COVID-19 Infection in Patients Receiving Radiotherapy
A Phase 2 study testing Hydroxychloroquine and Radiation therapy in people with COVID-19 and Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial summary
The researchers are doing this study to find out whether the study drug hydroxychloroquine can prevent infection with the COVID-19 virus, compared with placebo, in people who are receiving radiation therapy for their cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Hydroxychloroquine and Radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 7 sitesUnited States
- Study dates
- 7 May 2020to 21 Apr 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age ≥ 18
- ECOG 0-3
- For patients who have not started radiation at the time of screening: patients are required to have a plan in place for a minimum of 10 radiation treatments with or without concurrent systemic therapy
- For patients who have already started radiation at the time of screening: patients must complete enrollment such that they are able to receive at least 10 radiation treatments with hydroxychloroquine.
- Disease Site
- Mandatory inclusion criteria:
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- No COVID-19 symptoms within 14 days of enrollment:
- (Temp >38C in addition to sore throat, cough, wheezing, chest tightness, shortness of breath, body aches, chills, diarrhea, and anosmia)
- If symptoms are present within 14 days of enrollment, patients with a negative COVID-19 PCR or COVID-19 serology assay are eligible for inclusion.
- No close contact with confirmed COVID-19 person
- Close contact defined as:
- Within 6 feet for prolonged period
- Cohabitating
- Optional laboratory criteria (Recommended if available)
- Negative pre-treatment SARS-CoV-2 rapid antigen test result (within 1 week of enrollment)
- Negative pre-treatment SARS-CoV-2 PCR test result (within 1 week of enrollment) using MSKCC laboratory or outside laboratory assay
- Negative pre-treatment Standard Q COVID-19 IgM/IgG rapid serology result (within 1 week of enrollment)
- Blood serum for SARS-CoV-2 serology tests (being validated by MSKCC)
- Disease site meets following criteria:
- Head and Neck / High-Risk Skin Cancer
- Lung Cancer
- Breast Cancer
- Prostate Cancer
- Central Nervous System Tumors
- Gastrointestinal System Cancer
- Gynecologic cancer
- Other disease sites permitted at PI discretion
Who cannot join
- Previous positive test for SARS-CoV-2
- Previous positive serology test for SARS-CoV-2
- Recent Chest CT meeting CT exclusion criteria
- Live in a skilled nursing facility with COVID-19 symptoms (Temp >38 C in addition to sore throat, cough, wheezing, chest tightness, shortness of breath, body aches or chills, diarrhea, anosmia)
- Known hypersensitivity to hydroxychloroquine or 4-aminoquinoline derivatives
- Pre-existing retinopathy
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- Known chronic kidney disease, stage 4 or 5, or receiving dialysis
- Breast Feeding
- Tamoxifen
- Absolute neutrophil Count <1,000/ml at registration
- Concurrent use of any other quinine derivative
- Antiarrhythmic medications: amiodarone, sotalol, dofetilide, procainamide, quinidine, flecainide
- Glucose-6-phosphate dehydrogenase deficiency
- Pre-treatment corrected QT interval (QTc) ≥470 milliseconds**
- Prisoners
- Inability to participate
- Psoriasis
- History of suicidal ideation
- CT Criteria for Enrollment Exclusion (Optional - only for patients who received a diagnostic CT as part of standard of care or a thoracic CT as part of radiation simulation): All patients with COVID-19 typical radiographic findings on CT Chest as defined by the RSNA will be excluded. Patients with any NEW COVID-19 indeterminate radiographic findings on CT Chest that are concerning for COVID-19 will be excluded. COVID-19 indeterminate features are permitted if they can be demonstrated as STABLE on prior (>14 calendar days) CT Chest or PET/CT. If no prior comparison is available AND any intermediate or typical feature is present, the patient is not eligible.
- COVID-19 Atypical Features
- Isolated lobar or segmental consolidation without GGO
- Discrete small nodules (centrilobular, "tree-in-bud")
- Lung cavitation
- Smooth interlobular septal thickening with pleural effusion
- COVID-19 Indeterminate Features
- Multifocal, diffuse, perihilar, or unilateral GGO with or without consolidation lacking a specific distribution and are non-rounded or non-peripheral
- Few very small GGO with a non-rounded and non-peripheral distribution
- COVID-19 Typical Features
- Peripheral, bilateral GGO with or without consolidation or visible intralobular lines ("crazy paving")
- Multifocal GGO of rounded morphology with or without consolidation or visible intralobular lines ("crazy paving")
- Reverse Halo sign or other findings of organizing pneumonia ** If pre-treatment QTC can be decreased to <470, the patient can be re-considered for trial.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Memoral Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Commack (All Protocol Activities)
Commack, New York, 11725
Memoral Sloan Kettering Westchester (All protocol activities)
Harrison, New York, 10604
Memoral Sloan Kettering Monmouth (All protocol activities)
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen (All protocol Activities)
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Memorial Sloan Kettering Nassau (All Protocol Activities)
Uniondale, New York, 11553
About this study
Official title: A Phase II Randomized Double-Blind Placebo-Controlled Clinical Trial Of Hydroxychloroquine For Prophylaxis Against Covid-19 In Patients Receiving Radiotherapy (COVID)
The researchers are doing this study to find out whether the study drug hydroxychloroquine can prevent infection with the COVID-19 virus, compared with placebo, in people who are receiving radiation therapy for their cancer. The placebo used in this study is a tablet that looks the same as the study drug and is taken in the same way, but it does not contain any active ingredients.
- Being tested
- Hydroxychloroquine, Placebo, Radiation therapy
- Keywords
- Hydroxychloroquine, Radiotherapy, 20-176
- Medical subject headings
- COVID-19, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
400mg daily
PlaceboOther
400mg daily
Radiation therapyRadiation
Standard radiation therapy will be prescribed and administered as per the patient's radiation oncologist.
| Study group | Role | What they receive |
|---|---|---|
| Hydroxychloroquine | Experimental | Every patient on trial must be scheduled to receive at least 10 radiation treatments prior to initiation of hydroxychloroquine 400mg daily. Receives: Drug: Hydroxychloroquine; Radiation: Radiation therapy |
| Placebo | Placebo comparator | Every patient on trial must be scheduled to receive at least 10 radiation treatments prior to initiation of placebo 400mg daily. Receives: Other: Placebo; Radiation: Radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Incidence of SARS-CoV-2 Infection
Any patients who are enrolled and subsequently test positive for SARS-CoV-2 by RT-PCR (outside RT-PCR test results allowed) at any point during the 9 weeks following enrollment will be an event that is considered in the 9-week SARS-CoV-2 infection rate primary endpoint.
Measured: within 9 weeks from randomization
Secondary outcomes (1)
Cumulative Incidence of Severe COVID-19 or Death
Patients who are positive for SARS-CoV-2 (as defined above) who develop a new oxygen requirement attributable to COVID-19, tachypnea (RR > 20), or those who require hospitalization due to COVID-19 will be considered to have severe COVID-19.
Measured: within 12 weeks of randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2020
- Study start7 May 2020
- Primary completion21 Apr 2021
- Study completion21 Apr 2021
Why it stopped: The study was terminated based results of other studies and use of the new vaccine.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized (1:1), double-blind, placebo-controlled phase II clinical trial.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nancy Lee, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04381988
- Sponsor's protocol ID
- 20-176
- Status last verified
- Apr 2021
- First submitted
- 8 May 2020
- Last updated
- 27 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized Double-Blind Placebo-Controlled Clinical Trial Of Hydroxychloroquine For Prophylaxis Against Covid-19 In Patients Receiving Radiotherapy (COVID)
- ClinicalTrials.gov ID
- NCT04381988
- Acronym / sponsor ID
- 20-176
- Keywords
- Hydroxychloroquine, Radiotherapy, 20-176
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated based results of other studies and use of the new vaccine.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 7 May 2020 (actual)
- Primary completion
- 21 Apr 2021 (actual)
- Study completion
- 21 Apr 2021 (actual)
- First posted
- 11 May 2020 (actual)
- Results
- Posted 27 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The researchers are doing this study to find out whether the study drug hydroxychloroquine can prevent infection with the COVID-19 virus, compared with placebo, in people who are receiving radiation therapy for their cancer. The placebo used in this study is a tablet that looks the same as the study drug and is taken in the same way, but it does not contain any active ingredients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- This is a randomized (1:1), double-blind, placebo-controlled phase II clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Hydroxychloroquine | Experimental | Drug: Hydroxychloroquine, Radiation: Radiation therapyEvery patient on trial must be scheduled to receive at least 10 radiation treatments prior to initiation of hydroxychloroquine 400mg daily. |
| Placebo | Placebo comparator | Other: Placebo, Radiation: Radiation therapyEvery patient on trial must be scheduled to receive at least 10 radiation treatments prior to initiation of placebo 400mg daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Age ≥ 18
- ECOG 0-3
- For patients who have not started radiation at the time of screening: patients are required to have a plan in place for a minimum of 10 radiation treatments with or without concurrent systemic therapy
- For patients who have already started radiation at the time of screening: patients must complete enrollment such that they are able to receive at least 10 radiation treatments with hydroxychloroquine.
- Disease Site
Key exclusion criteria (31 listed)
- Previous positive test for SARS-CoV-2
- Previous positive serology test for SARS-CoV-2
- Recent Chest CT meeting CT exclusion criteria
- Live in a skilled nursing facility with COVID-19 symptoms (Temp >38 C in addition to sore throat, cough, wheezing, chest tightness, shortness of breath, body aches or chills, diarrhea, anosmia)
- Known hypersensitivity to hydroxychloroquine or 4-aminoquinoline derivatives
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 |
|---|---|---|
| Hydroxychloroquine400mg daily | Drug | Hydroxychloroquine |
| Placebo400mg daily | Other | Placebo |
| Radiation therapyStandard radiation therapy will be prescribed and administered as per the patient's radiation oncologist. | Radiation | Hydroxychloroquine, Placebo |
Primary outcome
Cumulative Incidence of SARS-CoV-2 Infection
Time frame: within 9 weeks from randomization
Any patients who are enrolled and subsequently test positive for SARS-CoV-2 by RT-PCR (outside RT-PCR test results allowed) at any point during the 9 weeks following enrollment will be an event that is considered in the 9-week SARS-CoV-2 infection rate primary endpoint.
1 secondary outcome
Cumulative Incidence of Severe COVID-19 or Death
Time frame: within 12 weeks of randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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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.
Nancy Lee, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites 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 Radiation therapy in people with COVID-19 and Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
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 27 inclusion and 31 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: stopped early, as of the sponsor's last update on 27 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 27 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cumulative Incidence of SARS-CoV-2 Infection (time frame: within 9 weeks from randomization). 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 27 Oct 2021.