Covid-19Phase 3MG-COVIDNCT04371406
Efficacy of Azithromycin-associated Hydroxychloroquine Therapy Given in General Practice in Early-stage Disease in COVID-19 Patients
A Phase 3 study testing Hydroxychloroquine and Azithromycin and Azinc in people with Covid-19, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
Hydroxychloroquine, a derivative of chloroquine (an antimalarial drug) with a weak immunosuppressive effect, is prescribed by some teams alone or in combination with azithromycin. No randomized controlled trials have demonstrated its efficacy, particularly in primary care in the early stages of the disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Covid-19
- What is being tested?
- Hydroxychloroquine and Azithromycin and Azinc
- 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
- No sites listed yet
- Study dates
- Apr 2020to Sep 2020
- Phase
- Phase 3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult aged 18 to 75 years old
- Taken into primary health care for suspicion of early-stage COVID-19 infection (maximum 5 days of evolution). The patient must have presented within the previous 5 days at least one of the following criteria: fever (≥38°C), cough, anosmia, agueusia, diarrhea, headache, myalgia.
- Criteria for randomization at D2 :
- Positive PCR on deep nasopharyngeal swab.
- Kalemia ≥ 3.5 mmol/L
- Normal magnesium and calcium levels (according to laboratory standards)
- QTc ≤ 460ms for women or QTc ≤ 450ms for men
- Beta-hCG negative
Who cannot join
- Comorbidity(ies) or clinical condition of the patient requiring immediate oxygen therapy, hospitalization and/or ventilatory assistance
- Concomitant treatment contraindicated, not recommended, or with precautions for use in combination with hydroxychloroquine or azithromycin:
- drug likely to induce torsades de pointe or at increased risk of ventricular arrhythmia, and in particular citalopram, escitalopram, hydroxyzine, domperidone, piperazine, class IA and III antiarrhythmics, tricyclic antidepressants, antipsychotics and certain anti-infectives (macrolides, fluoroquinolones).
- Alkaloids of ergot of rye, colchicine, cisapride
- proconvulsant or epileptogenic threshold lowering drugs: imipraminic antidepressants, selective serotonin reuptake inhibitors, neuroleptics (phenothiazines and butyrophenones) and tramadol.
- Known history of contraindications or increased risk of treatment with hydroxychloroquine or azithromycin (retinopathy,renal failure, significant liver failure, severe cholestasis, porphyria, known G6PD deficit, hypomagnesemia and hypokalemia, diabetes, myasthenia gravis, Heart diseases (heart failure, infarction, arrhythmia, congenital QTc prolongation, abnormalities that interfere with QTc measurement such as Left Bundle Branch Block, Right Bundle Branch Block, Pace maker with ventricular pacing), epilepsy, allergy to hydroxychloroquine, chloroquine, azithromycin, erythromycin, any other macrolide, ketolide or any of the excipients of Plaquenil® or Zithromax® or any of the components of Azinc form and vitality®.
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- Ongoing treatment with hydroxychloroquine or azithromycin, regardless of the indication.
- Taking other antiviral targeted therapy used in COVID-19 disease
- Women who are pregnant or breastfeeding or planning to become pregnant within 8 months of discontinuing hydroxychloroquine therapy.
- No National Health Insurrance (sécurité sociale, CMU or AME) coverage.
- Major under guardianship or curatorship
- Participation in another therapeutic clinical trial for COVID-19
- Refusal to participate in the study and/or lack of signature of a consent
About this study
Official title: Efficacy of Azithromycin-associated Hydroxychloroquine Therapy Given in General Practice in Early-stage Disease in COVID-19 Patients: Randomized Controlled Trial: MG-COVID
Hydroxychloroquine, a derivative of chloroquine (an antimalarial drug) with a weak immunosuppressive effect, is prescribed by some teams alone or in combination with azithromycin. No randomized controlled trials have demonstrated its efficacy, particularly in primary care in the early stages of the disease. However, currently available data suggest better efficacy if treatment is given early in the disease, before symptoms worsen. To date, the majority of COVID-19 patients treated in outpatient care, particularly in general practice, represent the majority of COVID-19 patients.
It is essential to evaluate, in primary care, the efficacy and safety of hydroxychloroquine combined with azithromycin in Covid-19 patients in order to be able to implement this therapeutic strategy as soon as the first symptoms appear. We realize a randomized, controlled, open superiority trial, in 2 parallel groups (ratio 1:1).The main objective is to assess the efficacy of Hydroxychloroquine combined with azithromycin in COVID-19 patients in primary care, in add-on to standard of care, on unfavorable outcome defined by the onset of at least one of the following between D0 and D14: hospitalization, death or percutaneous O² saturation ≤ 92% in ambient air.
Read the detailed description
Randomized, controlled, open superiority trial, in 2 parallel groups (ratio 1:1).
Eligible consecutive patient will be offered to take part in the trial during a visit to thier GP for COVID symptoms. After verification of eligibility criteria and written informed consent, a nasopharyngeal swab, an ECG and a blood sampled (kalaemia, magnesemia and calcemia) will be performed.
Patient with SARS-CoV-2 PCR positive result and still fulfilling eligibility criteria will be randomized on day2 (D2) through a web-based allocation system, following a computer generated allocation list, stratified on center and existence of any comorbidity, to experimental or control group. Patients without confirmation of SARS-CoV-2 infection on PCR will not continue the trial. Both groups patients will have a paper-based diary to record their daily symptoms and drug intake. A clinical follow-up will be done by the GP at D5, D8, D14 and D28.The main analysis population will be in intention to treat. An intermediate efficacy analysis is planned when 50% of patients have reached D14.
Two hundred consecutive patients (from pre-identified centers) will be included in an ancillary virological study to assess evolution of viral load at D8 and D14. For these patients all nasopharyngeal swab will be sent to a centralised lab at Pitié-Salpêtrière Hospital.
- Conditions
- Covid-19
- Being tested
- Hydroxychloroquine and Azithromycin, Azinc
- Keywords
- Covid-19, hydroxychloroquine, primary care, azithromycin
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxychloroquine and AzithromycinDrug
Hydroxychloroquine sulfate (PLAQUENIL®), 200mg x 3 /d, for 10 days AND Azithromycin (ZITHROMAX®), 500mg on D1 and then 250mg/d for the next 4 days, in addition to standard of care
AzincDietary supplement
Dietetary supplement, Azinc form and vitality®, 2 capsules per day, for 10 days, in addition to standard of care
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Hydroxychloroquine sulfate (PLAQUENIL®), 200mg x 3 /d, for 10 days AND Azithromycin (ZITHROMAX®), 500mg on D1 and then 250mg/d for the next 4 days, in addition to standard of care Receives: Drug: Hydroxychloroquine and Azithromycin |
| Control Arm | Sham comparator | Dietetary supplement, Azinc form and vitality®, 2 capsules per day, for 10 days, in addition to standard of care Receives: Dietary Supplement: Azinc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients with occurrence of an unfavorable outcome between randomization and day 14
Unfavorable outcome defined by the onset of at least one of the following between randomization and day 14: hospitalization, death or percutaneous O² saturation ≤ 92% in ambient air
Measured: between randomization and day14
Primary outcome of ancillary virological study : evolution of viral load between day 0 and day 14
Ancillary virological study : evolution of viral load between day 0 and day 14, measured by the threshold cycle,Ct, with PCR on naso-pharyngeal swab
Measured: between day 0 and day 14
Secondary outcomes (24)
The all-cause mortality rate at day 14
Measured: day 14
The all-cause mortality rate at day 28
Measured: day 28
Rate of patients with occurrence of an unfavorable outcome between randomization and day 28
Unfavorable outcome defined by the onset of at least one of the following between randomization and day 28: hospitalization, death or percutaneous O² saturation ≤ 92% in ambient air
Measured: between randomization and day 28
The rate of use of mechanical ventilation at day 14
Measured: day 14
The rate of use of mechanical ventilation at day 28
Measured: day 28
The Intensive Care Unit admission rate at day 14
Measured: day 14
The Intensive Care Unit admission rate at day 28
Measured: day 28
Number of days of hospitalization for any cause between day 0 and day 14
Measured: between randomization and day 14
Number of days of hospitalization for any cause between day 0 and day 28
Measured: between randomization and day 28
The time to resolution of all COVID symptoms at day 14
Time to resolution of all COVID-19 symptoms : no COVID symptom for at least 48 hours without symptomatic treatment in previous 24 hours
Measured: day 14
The time to resolution of all COVID symptoms atday 28
Time to resolution of all COVID-19 symptoms : no COVID symptom for at least 48 hours without symptomatic treatment in previous 24 hours
Measured: day 28
The rate of use of oxygen therapy at day 14
Measured: between randomization and day 14
The rate of use of oxygen therapy at day 28
Measured: between randomization and day 28
The rate of use of secondary antibiotic therapy (after day 2) at day 14
Measured: between randomization and day 14
The rate of use of secondary antibiotic therapy (after day 2) at day 28
Measured: between randomization and day 28
Clinical status at day 14
Clinical status on a 7-point ordinal scale :
- Not hospitalized, no limitations on activities
- Not hospitalized, limitation on activities;
- Hospitalized, not requiring supplemental oxygen;
- Hospitalized, requiring supplemental oxygen;
- Hospitalized, on non-invasive ventilation or high flow oxygen devices;
- Hospitalized, on invasive mechanical ventilation or ECMO;
- Death.
Measured: day 14
Clinical status at day 28
Clinical status on a 7-point ordinal scale :
- Not hospitalized, no limitations on activities
- Not hospitalized, limitation on activities;
- Hospitalized, not requiring supplemental oxygen;
- Hospitalized, requiring supplemental oxygen;
- Hospitalized, on non-invasive ventilation or high flow oxygen devices;
- Hospitalized, on invasive mechanical ventilation or ECMO;
- Death.
Measured: day 28
number of serious adverse events at day 14
Measured: day 14
number serious adverse events at day 28
Measured: day 28
number of adverse events at day 14
Measured: day 14
number of adverse events at day 28
Measured: day 28
The rate of patients with treatment withdrawal
Measured: day 14
Ancillary virological study : rate of patients with negative viral load at day 8
Ancillary virological study : rate of patients with negative viral load at PCR on naso pharyngeal swab at day 8
Measured: day 8
Ancillary virological study : rate of patients with negative viral load at day 14
Ancillary virological study : rate of patients with negative viral load at PCR on naso pharyngeal swab at day 14
Measured: day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study startApr 2020 (estimated)
- Primary completionAug 2020 (estimated)
- Study completionSep 2020 (estimated)
Why it stopped: Regulatory approvals have not been obtained
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid-19Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julie CHASTANG, Dr, Principal investigator, Department of General Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04371406
- Sponsor's protocol ID
- APHP200447
- Other IDs
- 2020-001702-35
- Acronym
- MG-COVID
- Status last verified
- Apr 2020
- First submitted
- 29 Apr 2020
- Last updated
- 27 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Azithromycin-associated Hydroxychloroquine Therapy Given in General Practice in Early-stage Disease in COVID-19 Patients: Randomized Controlled Trial: MG-COVID
- ClinicalTrials.gov ID
- NCT04371406
- Acronym / sponsor ID
- MG-COVID / APHP200447
- Conditions
- Covid-19
- Keywords
- Covid-19, hydroxychloroquine, primary care, azithromycin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Regulatory approvals have not been obtained
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Apr 2020 (estimated)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 1 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.
Hydroxychloroquine, a derivative of chloroquine (an antimalarial drug) with a weak immunosuppressive effect, is prescribed by some teams alone or in combination with azithromycin. No randomized controlled trials have demonstrated its efficacy, particularly in primary care in the early stages of the disease. However, currently available data suggest better efficacy if treatment is given early in the disease, before symptoms worsen. To date, the majority of COVID-19 patients treated in outpatient care, particularly in general practice, represent the majority of COVID-19 patients.
It is essential to evaluate, in primary care, the efficacy and safety of hydroxychloroquine combined with azithromycin in Covid-19 patients in order to be able to implement this therapeutic strategy as soon as the first symptoms appear. We realize a randomized, controlled, open superiority trial, in 2 parallel groups (ratio 1:1).The main objective is to assess the efficacy of Hydroxychloroquine combined with azithromycin in COVID-19 patients in primary care, in add-on to standard of care, on unfavorable outcome defined by the onset of at least one of the following between D0 and D14: hospitalization, death or percutaneous O² saturation ≤ 92% in ambient air.
Detailed description
Randomized, controlled, open superiority trial, in 2 parallel groups (ratio 1:1).
Eligible consecutive patient will be offered to take part in the trial during a visit to thier GP for COVID symptoms. After verification of eligibility criteria and written informed consent, a nasopharyngeal swab, an ECG and a blood sampled (kalaemia, magnesemia and calcemia) will be performed.
Patient with SARS-CoV-2 PCR positive result and still fulfilling eligibility criteria will be randomized on day2 (D2) through a web-based allocation system, following a computer generated allocation list, stratified on center and existence of any comorbidity, to experimental or control group. Patients without confirmation of SARS-CoV-2 infection on PCR will not continue the trial. Both groups patients will have a paper-based diary to record their daily symptoms and drug intake. A clinical follow-up will be done by the GP at D5, D8, D14 and D28.The main analysis population will be in intention to treat. An intermediate efficacy analysis is planned when 50% of patients have reached D14.
Two hundred consecutive patients (from pre-identified centers) will be included in an ancillary virological study to assess evolution of viral load at D8 and D14. For these patients all nasopharyngeal swab will be sent to a centralised lab at Pitié-Salpêtrière Hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Drug: Hydroxychloroquine and AzithromycinHydroxychloroquine sulfate (PLAQUENIL®), 200mg x 3 /d, for 10 days AND Azithromycin (ZITHROMAX®), 500mg on D1 and then 250mg/d for the next 4 days, in addition to standard of care |
| Control Arm | Sham comparator | Dietary Supplement: AzincDietetary supplement, Azinc form and vitality®, 2 capsules per day, for 10 days, in addition to standard of care |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adult aged 18 to 75 years old
- Taken into primary health care for suspicion of early-stage COVID-19 infection (maximum 5 days of evolution). The patient must have presented within the previous 5 days at least one of the following criteria: fever (≥38°C), cough, anosmia, agueusia, diarrhea, headache, myalgia.
- Positive PCR on deep nasopharyngeal swab.
- Kalemia ≥ 3.5 mmol/L
- Normal magnesium and calcium levels (according to laboratory standards)
Key exclusion criteria (13 listed)
- Comorbidity(ies) or clinical condition of the patient requiring immediate oxygen therapy, hospitalization and/or ventilatory assistance
- Concomitant treatment contraindicated, not recommended, or with precautions for use in combination with hydroxychloroquine or azithromycin:
- Known history of contraindications or increased risk of treatment with hydroxychloroquine or azithromycin (retinopathy,renal failure, significant liver failure, severe cholestasis, porphyria, known G6PD deficit, hypomagnesemia and hypokalemia, diabetes, myasthenia gravis, Heart diseases (heart failure, infarction, arrhythmia, congenital QTc prolongation, abnormalities that interfere with QTc measurement such as Left Bundle Branch Block, Right Bundle Branch Block, Pace maker with ventricular pacing), epilepsy, allergy to hydroxychloroquine, chloroquine, azithromycin, erythromycin, any other macrolide, ketolide or any of the excipients of Plaquenil® or Zithromax® or any of the components of Azinc form and vitality®.
- Ongoing treatment with hydroxychloroquine or azithromycin, regardless of the indication.
- Taking other antiviral targeted therapy used in COVID-19 disease
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 and AzithromycinHydroxychloroquine sulfate (PLAQUENIL®), 200mg x 3 /d, for 10 days AND Azithromycin (ZITHROMAX®), 500mg on D1 and then 250mg/d for the next 4 days, in addition to standard of care | Drug | Experimental Arm |
| AzincDietetary supplement, Azinc form and vitality®, 2 capsules per day, for 10 days, in addition to standard of care | Dietary supplement | Control Arm |
Primary outcome
Rate of patients with occurrence of an unfavorable outcome between randomization and day 14
Time frame: between randomization and day14
Unfavorable outcome defined by the onset of at least one of the following between randomization and day 14: hospitalization, death or percutaneous O² saturation ≤ 92% in ambient air
Primary outcome of ancillary virological study : evolution of viral load between day 0 and day 14
Time frame: between day 0 and day 14
Ancillary virological study : evolution of viral load between day 0 and day 14, measured by the threshold cycle,Ct, with PCR on naso-pharyngeal swab
24 secondary outcomes
The all-cause mortality rate at day 14
Time frame: day 14
The all-cause mortality rate at day 28
Time frame: day 28
Rate of patients with occurrence of an unfavorable outcome between randomization and day 28
Time frame: between randomization and day 28
The rate of use of mechanical ventilation at day 14
Time frame: day 14
The rate of use of mechanical ventilation at day 28
Time frame: day 28
The Intensive Care Unit admission rate at day 14
Time frame: day 14
The Intensive Care Unit admission rate at day 28
Time frame: day 28
Number of days of hospitalization for any cause between day 0 and day 14
Time frame: between randomization and day 14
Number of days of hospitalization for any cause between day 0 and day 28
Time frame: between randomization and day 28
The time to resolution of all COVID symptoms at day 14
Time frame: day 14
The time to resolution of all COVID symptoms atday 28
Time frame: day 28
The rate of use of oxygen therapy at day 14
Time frame: between randomization and day 14
The rate of use of oxygen therapy at day 28
Time frame: between randomization and day 28
The rate of use of secondary antibiotic therapy (after day 2) at day 14
Time frame: between randomization and day 14
The rate of use of secondary antibiotic therapy (after day 2) at day 28
Time frame: between randomization and day 28
Clinical status at day 14
Time frame: day 14
Clinical status at day 28
Time frame: day 28
number of serious adverse events at day 14
Time frame: day 14
number serious adverse events at day 28
Time frame: day 28
number of adverse events at day 14
Time frame: day 14
number of adverse events at day 28
Time frame: day 28
The rate of patients with treatment withdrawal
Time frame: day 14
Ancillary virological study : rate of patients with negative viral load at day 8
Time frame: day 8
Ancillary virological study : rate of patients with negative viral load at day 14
Time frame: day 14
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 27 Oct 2020.
- Individual participant dataSharing planned: Yes. Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
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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.
Julie CHASTANG, Dr principal investigator
Department of General Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hydroxychloroquine and Azithromycin and Azinc in people with Covid-19, run by Assistance Publique - Hôpitaux de Paris.
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 8 inclusion and 13 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 27 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Rate of patients with occurrence of an unfavorable outcome between randomization and day 14 (time frame: between randomization and day14). 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 27 Oct 2020.