A Phase 3 interventional study of Hydroxychloroquine and Azithromycin and Azinc in Covid-19, sponsored by Assistance Publique - Hôpitaux de Paris. Withdrawn. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-10-27.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 3, Interventional, and Treatment
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.
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
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Inclusion Criteria:
Criteria for randomization at D2 :
Exclusion criteria :
Concomitant treatment contraindicated, not recommended, or with precautions for use in combination with hydroxychloroquine or azithromycin:
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
Drug: Hydroxychloroquine and Azithromycin
Dietetary supplement, Azinc form and vitality®, 2 capsules per day, for 10 days, in addition to standard of care
Dietary Supplement: Azinc
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
Dietetary supplement, Azinc form and vitality®, 2 capsules per day, for 10 days, in addition to standard of care
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
Time frame: 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
Time frame: between day 0 and day 14
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
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
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 to resolution of all COVID-19 symptoms : no COVID symptom for at least 48 hours without symptomatic treatment in previous 24 hours
Time frame: 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
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
Clinical status on a 7-point ordinal scale : 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities; 3. Hospitalized, not requiring supplemental oxygen; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices; 6. Hospitalized, on invasive mechanical ventilation or ECMO; 7. Death.
Time frame: day 14
Clinical status at day 28
Clinical status on a 7-point ordinal scale : 1. Not hospitalized, no limitations on activities 2. Not hospitalized, limitation on activities; 3. Hospitalized, not requiring supplemental oxygen; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices; 6. Hospitalized, on invasive mechanical ventilation or ECMO; 7. Death.
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
Ancillary virological study : rate of patients with negative viral load at PCR on naso pharyngeal swab at day 8
Time frame: 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
Time frame: day 14
No study locations are listed for this record.
Plan to share: 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.
Supporting information: Study protocol, Sap, Icf
No publications or documents are linked to this record.
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Assistance Publique - Hôpitaux de Paris