Non-comparative Trial of the Combination of HCQ and AZI in the Treatment of ICU Patients
Condition: COVID-19
MeSH terms: COVID-19
Intervention: Hydroxychloroquine; Azithromycin
Intervention description: Hydroxychloroquine 400 mg BID, on day 1 and then 200 mg BID day 2 through 7 IV or po for 5 days. If the condition of the patient does not allow for oral therapy, HCQ can be given via a feeding or NG tube. Azithromycin can be given intravenously.; Azithromycin 500 mg, IV or po for 5 days
Intervention MeSH terms: Azithromycin; Hydroxychloroquine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This research is designed as an open-label,non-comparative prospective trial.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adults aged >18 years of age with lower respiratory infection with SARSCo2 documented
             by a positive RT-PCR in nasopharyngeal sample admitted to the University of New Mexico
             Hospital, with an oxygen saturation of less than 94%, on room air, or a respiratory
             rate >24 per minute, or HR>125 per minute of a PaO2/FIO2<150.

          2. Patient with life expectancy >48 hours.

          3. Pregnant women may be included if deemed necessary. There is insufficient information
             regarding the safety of hydroxychloroquine and azithromycin during pregnancy.
             Consequently, these medications are not recommended when pregnant or planning to
             become pregnant. However, investigators may prescribe hydroxychloroquine and
             azithromycin if deemed necessary.

          4. Azithromycin is excreted in human milk, therefore participants should not breast-feed
             whilst taking Azithromycin, because it may cause side effects including diarrhoea and
             infection to a baby. It is recommended to discard the milk during treatment and up
             until 2 days after discontinuation of treatment. Additionally, hydroxychloroquine
             should not be taken whilst breast-feeding. However, investigators may prescribe
             hydroxychloroquine and azithromycin if deemed necessary. Page 6 of 23 Version Date:
             04.16.2020

          5. Adults unable to consent will be included with the consent of their Legally Authorized
             Representative (LAR). Assent will be pursued from cognitively impaired participants if
             they are able to provide assent. Note that this does not preclude the enrollment of
             cognitively impaired participants that cannot provide assent, but would allow those
             that can the opportunity to do so.

        Exclusion Criteria:

          1. Prisoners

          2. Pre-/co-existing medical conditions, including any of the following:

             Known allergy to study drugs. Contraindication to treatment with study drugs,
             including retinopathy, and QTc prolongation defined by QTc>450 in males and >470 in
             females. Unless, it is the opinion of the treating physician(s) that the benefits to
             treat with medications outweigh the risks. Known chronic kidney disease, stage 4 or 5
             or receiving dialysis. Glucose-6-phosphate dehydrogenase (G6PD) deficiency.

          3. Weight <40 kg.

          4. Current use of: hydrocholoroquine or cardiac medicines of: flecainade, Tambocor;
             amiodarone Cordarone, Pacerone; digoxin or Digox, Digitek, Lanoxin; procainamide or
             Procan,Procanbid, propafenone, Rythmal.