COVID19Phase 2HYACINTHENCT04392128
Study Evaluating the Efficacy of Hydroxychloroquine and Azithromycine in Patients With COVID-19 and Hematological Malignancies (HYACINTHE)
A Phase 2 study testing Hydroxychloroquine Sulfate 200 MG [Plaquenil] and Azithromycin 250 MG Oral Capsule in people with COVID19 and Hematologic Malignancy, run by Institut de cancérologie Strasbourg Europe at 1 site in France.
Trial summary
The primary objective of this phase 2, multicentric, placebo-controlled double-blind, randomized study is to evaluate the efficacy of the combination of hydroxychloroquine and azithromycine on the viral load drop at day 5 among patients with COVID-19 and hematological malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID19, Hematologic Malignancy
- What is being tested?
- Hydroxychloroquine Sulfate 200 MG [Plaquenil] and Azithromycin 250 MG Oral Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 2 Sep 2020to 2 Sep 2020
- 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
- 18 years or older patients
- Patient with hematologic malignancy who received or not hematopoietic stem cell transplantation
- Non severe Covid-19 disease
- PCR-confirmed COVID-19 disease by a nasopharyngeal swab
- Life-expectancy related to the hematologic malignancy of at least 1 month
- Men or women of child-bearing potential accepting to use effective contraception during and until 8 months after the end of the study treatment
Who cannot join
- Patients with severe form of COVID-19 infection defined as the presence of crackles observed during clinical exam, associated with less than 94% oxygen saturation or patients with respiratory insufficiency on oxygen therapy or mechanical ventilation
- Previous treatment with hydroxychloroquine or azithromycine for Covid-19 infection
- QTc interval greater than 480 ms
- Hypersensibility to hydroxychloroquine or azithromycine
- Retinopathy
- TGO or TGP geater than 5 x the normal upper limit
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- Creatinine clearance lower than 30 ml/min
- Concomitant treatment that may lead to prolongation of the QT space
- Concomitant treatment with dihydroergotamine, ergotamine, cisapride or colchicine
- Known G6PD deficiency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised, Double-blind, Placebo-controlled Phase 2 Study Evaluating the Efficacy of Hydroxychloroquine and Azithromycine in Patients With COVID-19 and Hematological Malignancies
The primary objective of this phase 2, multicentric, placebo-controlled double-blind, randomized study is to evaluate the efficacy of the combination of hydroxychloroquine and azithromycine on the viral load drop at day 5 among patients with COVID-19 and hematological malignancies.
Read the detailed description
The study will evaluate the effect of the combination of hydroxychloroquine and azithromycine versus placebo among 114 patients with COVID-19 and hematologic malignancy.
After randomization in 1:1 ratio, patients will receive either the study treatment or placebo :
- Patients enrolled in the experimental arm will receive hydroxychloroquine (200mgx3 tablets per day during 10 days) and azithromycine (500 mg at day 1 then 250mg per day during 4 days)
- Patients enrolled in the control arm will receive a placebo of hydroxychloroquine (3 tablets per day during 10 days) and a placebo of azithromycine (2 capsules at day 1, then 1 capsule per day during 4 days)
- Conditions
- COVID19, Hematologic Malignancy
- Being tested
- Hydroxychloroquine Sulfate 200 MG [Plaquenil], Azithromycin 250 MG Oral Capsule, Placebo oral tablet, Placebo oral capsule
- Keywords
- SARS-CoV-2, Hematologic malignancy
- Medical subject headings
- COVID-19, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxychloroquine Sulfate 200 MG [Plaquenil]Drug
Hydroxychloroquine is an anti-malarial drug also used as anti-inflammatory treatment for systemic lupus erythematosus and rheumatic disorders. HCQ also inhibits pH-dependant replication stages of diverse types of viruses including flavivirus, retrovirus and coronaviruses.
Azithromycin 250 MG Oral CapsuleDrug
Azithromycin is amacrolide antibiotic.
Placebo oral tabletDrug
Placebo of Hydroxychloroquine Sulfate 200 MG [Plaquenil].
Placebo oral capsuleDrug
Placebo of Azithromycin capsules.
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Patients enrolled in the experimental arm will receive hydroxychloroquine (200mgx3 tablets per day during 10 days) and azithromycine (500 mg at day 1 (2 capsules taken at the same time) then 250mg per day (1 capsule per day) during 4 days). Receives: Drug: Hydroxychloroquine Sulfate 200 MG [Plaquenil]; Drug: Azithromycin 250 MG Oral Capsule |
| Control arm | Placebo comparator | Patients enrolled in the control arm will receive a placebo of hydroxychloroquine (3 tablets per day during 10 days) and a placebo of azithromycine (2 capsules taken at the same time at day 1, then 1 capsule per day during 4 days) Receives: Drug: Placebo oral tablet; Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the efficacy of hydroxychloroquine and azithromyncine on the viral load drop at day 5.
Locally evaluated rate of viral response. Favorable response is defined as (1) complete response : negative PCR (absence of detectable signal with a minimum of 40 cycles) or (2) major response : detectable signal but with an increased number of cycles > or egal to 10 compared to initial PCR. Response failure is defined as (1) minor response : detectable signal but with an increased number of cycles < 10 compared to initial PCR or (2) stabilisation or worsening of the viral load.
Measured: 5 days of treatment
Secondary outcomes (12)
Clinical evolution
Duration of fever - duration of respiratory symptoms (cough, dyspnea) - duration of other COVID-19 related symptoms (digestive symptoms, ageusia, anosmia)
Measured: up to 3 months
Proportion of patients progressing to a severe form
Less or equal to 94% oxygen saturation - need to initiate oxygenotherapy - occurrence of respiratory distress - patient transfer in intensive care unit - need of mechanical ventilation - occurrence of non-respiratory organ failure - occurrence of septic shock
Measured: up to 3 months
Mortality
Date and cause of death
Measured: up to 1 and 3 months
Evaluation of viral load drop
SARS-CoV-2 viral load by PCR on nasopharyngeal swab at day 10 (if positive at day 5) : rate of negativation and comparison of number of cycles with previous samples
Measured: at day 10
Tolerance of study treatment
Frequence and causality of all-grade cardiac adverse events - frequence and causality of grade > 1 adverse events for other adverse events - frequence and causality of serious adverse events (CTCAE v5)
Measured: up to 3 months
Evaluation of the seroconversion
Collection of serum to realize serological tests
Measured: at inclusion, day 10, day 30 and day 90 after treatment
NK immunological study
Phenotypic and functional study of NK lymphocytes at inclusion, Retrospective analysis on frozen cells.
Measured: at day 10 and day 30 after treatment
Hospitalisation duration
Duration of hospitalisation (conventional, intensive care, reanimation)
Measured: up to 3 months
Impact of the study treatment on the treatment of the hematological disease
Patient follow-up during 3 months : hematological status and associated therapy
Measured: up to 3 months
Monitoring of the QT space
ECG (using connected machine to allow monitoring at home)
Measured: at inclusion, day 2, day 5, day 10
Dosage of residual concentration of azithromycine and hydroxychloroquine.
Dosage of residual concentration of azithromycine and hydroxychloroquine.
Measured: at day 5 and day 10
T immunological study
Phenotypic and functional study of T lymphocytes at inclusion, Retrospective analysis on frozen cells.
Measured: at day 10 and day 30 after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study start2 Sep 2020
- Primary completion2 Sep 2020
- Study completion2 Sep 2020
Why it stopped: competent authority decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID19Studies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de cancérologie Strasbourg Europe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04392128
- Sponsor's protocol ID
- 2020-005
- Other IDs
- 2020-002002-45
- Acronym
- HYACINTHE
- Status last verified
- Sep 2020
- First submitted
- 15 May 2020
- Last updated
- 4 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Double-blind, Placebo-controlled Phase 2 Study Evaluating the Efficacy of Hydroxychloroquine and Azithromycine in Patients With COVID-19 and Hematological Malignancies
- ClinicalTrials.gov ID
- NCT04392128
- Acronym / sponsor ID
- HYACINTHE / 2020-005
- Conditions
- COVID19, Hematologic Malignancy
- Keywords
- SARS-CoV-2, Hematologic malignancy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: competent authority decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Institut de cancérologie Strasbourg EuropeUniversity, hospital or other
- Study start
- 2 Sep 2020 (actual)
- Primary completion
- 2 Sep 2020 (actual)
- Study completion
- 2 Sep 2020 (actual)
- First posted
- 18 May 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.
The primary objective of this phase 2, multicentric, placebo-controlled double-blind, randomized study is to evaluate the efficacy of the combination of hydroxychloroquine and azithromycine on the viral load drop at day 5 among patients with COVID-19 and hematological malignancies.
Detailed description
The study will evaluate the effect of the combination of hydroxychloroquine and azithromycine versus placebo among 114 patients with COVID-19 and hematologic malignancy.
After randomization in 1:1 ratio, patients will receive either the study treatment or placebo :
- Patients enrolled in the experimental arm will receive hydroxychloroquine (200mgx3 tablets per day during 10 days) and azithromycine (500 mg at day 1 then 250mg per day during 4 days)
- Patients enrolled in the control arm will receive a placebo of hydroxychloroquine (3 tablets per day during 10 days) and a placebo of azithromycine (2 capsules at day 1, then 1 capsule per day during 4 days)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Drug: Hydroxychloroquine Sulfate 200 MG [Plaquenil], Drug: Azithromycin 250 MG Oral CapsulePatients enrolled in the experimental arm will receive hydroxychloroquine (200mgx3 tablets per day during 10 days) and azithromycine (500 mg at day 1 (2 capsules taken at the same time) then 250mg per day (1 capsule per day) during 4 days). |
| Control arm | Placebo comparator | Drug: Placebo oral tablet, Drug: Placebo oral capsulePatients enrolled in the control arm will receive a placebo of hydroxychloroquine (3 tablets per day during 10 days) and a placebo of azithromycine (2 capsules taken at the same time at day 1, then 1 capsule per day during 4 days) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years or older patients
- Patient with hematologic malignancy who received or not hematopoietic stem cell transplantation
- Non severe Covid-19 disease
- PCR-confirmed COVID-19 disease by a nasopharyngeal swab
- Life-expectancy related to the hematologic malignancy of at least 1 month
Key exclusion criteria (10 listed)
- Patients with severe form of COVID-19 infection defined as the presence of crackles observed during clinical exam, associated with less than 94% oxygen saturation or patients with respiratory insufficiency on oxygen therapy or mechanical ventilation
- Previous treatment with hydroxychloroquine or azithromycine for Covid-19 infection
- QTc interval greater than 480 ms
- Hypersensibility to hydroxychloroquine or azithromycine
- Retinopathy
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 |
|---|---|---|
| Hydroxychloroquine Sulfate 200 MG [Plaquenil]Hydroxychloroquine is an anti-malarial drug also used as anti-inflammatory treatment for systemic lupus erythematosus and rheumatic disorders. HCQ also inhibits pH-dependant replication stages of diverse types of viruses including flavivirus, retrovirus and coronaviruses. | Drug | Treatment arm |
| Azithromycin 250 MG Oral CapsuleAzithromycin is amacrolide antibiotic. | Drug | Treatment arm |
| Placebo oral tabletPlacebo of Hydroxychloroquine Sulfate 200 MG [Plaquenil]. | Drug | Control arm |
| Placebo oral capsulePlacebo of Azithromycin capsules. | Drug | Control arm |
Primary outcome
Evaluation of the efficacy of hydroxychloroquine and azithromyncine on the viral load drop at day 5.
Time frame: 5 days of treatment
Locally evaluated rate of viral response. Favorable response is defined as (1) complete response : negative PCR (absence of detectable signal with a minimum of 40 cycles) or (2) major response : detectable signal but with an increased number of cycles > or egal to 10 compared to initial PCR. Response failure is defined as (1) minor response : detectable signal but with an increased number of cycles < 10 compared to initial PCR or (2) stabilisation or worsening of the viral load.
12 secondary outcomes
Clinical evolution
Time frame: up to 3 months
Proportion of patients progressing to a severe form
Time frame: up to 3 months
Mortality
Time frame: up to 1 and 3 months
Evaluation of viral load drop
Time frame: at day 10
Tolerance of study treatment
Time frame: up to 3 months
Evaluation of the seroconversion
Time frame: at inclusion, day 10, day 30 and day 90 after treatment
NK immunological study
Time frame: at day 10 and day 30 after treatment
Hospitalisation duration
Time frame: up to 3 months
Impact of the study treatment on the treatment of the hematological disease
Time frame: up to 3 months
Monitoring of the QT space
Time frame: at inclusion, day 2, day 5, day 10
Dosage of residual concentration of azithromycine and hydroxychloroquine.
Time frame: at day 5 and day 10
T immunological study
Time frame: at day 10 and day 30 after treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2020.
- Individual participant dataSharing planned: No
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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.
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?
A Phase 2 study testing Hydroxychloroquine Sulfate 200 MG [Plaquenil] and Azithromycin 250 MG Oral Capsule in people with COVID19 and Hematologic Malignancy, run by Institut de cancérologie Strasbourg Europe 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 10 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: withdrawn, as of the sponsor's last update on 4 Sep 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. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Evaluation of the efficacy of hydroxychloroquine and azithromyncine on the viral load drop at day 5. (time frame: 5 days of treatment). 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 4 Sep 2020.