Clinical trial: Hydroxychloroquine Azithromycin COVID-19 Pregnancy Trial (NCT04365231)

Eligibility criteria:
Inclusion Criteria:

          -  pregnant

          -  18 and over

          -  monofetal pregnancy between 22+0 and 41+0 weeks of gestation

          -  presenting a positive COVID-19 RT-PCR test result after nasopharyngeal swab for one or
             more minor symptoms: cough, body temperature >37,3 °C, shortness of breath, diarrhea,
             asthenia, anosmia, taste loss, myalgia

          -  presenting no contraindication to hydroxychloroquine and azithromycin

          -  informed consent signature

          -  affiliated to social security scheme

        Exclusion Criteria:

          -  allergic to hydroxychloroquine or chloroquine, or azithromycin

          -  contraindication to hydroxychloroquine: retinopathy, G6PD deficiency, long QT
             syndrome, any other heart rhythm abnormality on pre-recruitment electrocardiogram,
             hypokalemia, porphyria, psoriasis.

          -  contraindication to azithromycin: long QT syndrome, liver failure, myasthenia

          -  receiving simultaneous treatments contraindicated in case of hydroxychloroquine
             uptake: Citalopram (Seropram), escitalopram (Seroplex), hydroxyzin (Atarax),
             domperidone (Motilium), piperaquine (Eurartesim), disopyramide (Isorythm, Rythmodan),
             hydroquinidine chlorydrate (Serecor), amiodarone (Cordarone), dronedaron (Multaq),
             tricyclic antidepressant, anti-infectious drugs (macrolids, fluoroquinolones,
             trimethoprime-sulfamethoxazole (Bactrim).

          -  receiving simultaneous treatments contraindicated in case of azithromycin uptake:
             Cisapride, Colchicine, Dihydroergotamine, bromocriptine, cabergoline, lisurid,
             pergolide, atorvastatin, ciclosporin, digoxin, simvastatin, anti-vitamine K,
             macrolids, ketolide

          -  hypoxemic respiratory failure due to severe pneumonia (needing supplemental oxygen)

          -  maternal disorders: Type I or II diabetes, congenital cardiopathy, liver or kidney
             disease, liver failure, renal failure

          -  obstetrical disorders: insulin-dependent gestational diabetes, preterm delivery
             threat, preterm rupture of membranes, bleeding, pre-eclampsia, gestational
             hypertension, gestational cholestasis
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


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? Contradiction