Clinical trial: Efficacy of Azithromycin-associated Hydroxychloroquine Therapy Given in General Practice in Early-stage Disease in COVID-19 Patients (NCT04371406)

Eligibility criteria:
Inclusion Criteria:

          -  Inclusion criteria :

          -  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

        Exclusion criteria :

          -  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®.

          -  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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years

Patient description (medical language): The patient is a 38-year-old man with cough and body ache that started 3 days ago.  He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx.

Patient description (patient's own words): I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat.

Does the patient match the trial criteria? Entailment