This research is designed as an open-label,non-comparative prospective trial.
The objects of this research are as follows:
(1) To measure the duration of viral shedding in respiratory secretions of patients with
moderate or severe COVID-19 infection treated with the combination of Hydroxychloroquine and
azithromycin. (2) Evaluate the case fatality rate, the clinical response and length of stay
in hospitalized patients with moderate and severe COVID-19 infection. (3) To report the
safety of the drug combination in hospitalized patients with moderate and severe COVID-19
infection.
Drug: Hydroxychloroquine
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.
Drug: Azithromycin
Azithromycin 500 mg, IV or po for 5 days
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.
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, United States