The present study is a randomized, double-blind, controlled, clinical trial, with the approval of the ethics committee will be conducted on patients who have a positive test confirming COVID-19 in Shahid Modarres Medical Education Center and Hospital in Tehran. Patients will be randomly assigned to the two arms of the study and after completing the course of treatment and collecting and analyzing the necessary information from each patient, the results of the study will be published both on this site and in the form of an article in a reputable international journal.
Chloroquine has been a broadly-utilized anti-malaria agent which back in 2006, had been
proved to be a powerful wide-spectrum antiviral. Moreover, Chloroquine has the
characteristics of anti-inflammatory and immune-modulatory by inhibiting the production of
TNF-α along with IL-6. In the first half of February, a study illustrated puissant inhibition
of SARS-CoV-2 by Chloroquine, when taking two 500-mg tablets of it by mouth per day; similar
to some clinical studies in China through this outbreak. According to the news briefing of a
study, it was indicated that chloroquine phosphate actually outdo the control treatment in
inhibition of pneumonia exacerbation, improving lung imaging findings, and curtailing the
disease course. Another study evaluated the possible doses of CQ and HCQ to find the
optimized dose in treatment of COVID-19. They revealed that while within in-vitro settings
Hydroxychloroquine is more potent than chloroquine. As a conclusion, they suggested a 800 mg
daily dose of hydroxychloroquine, followed by an overall maintenance dose of 400 mg per day
divided in two separate doses, which was three-fold more potent compared to the 500 mg twice
daily administration of chloroquine in 5 days. The new study published in 16th March, pointed
out that hydroxychloroquine was notably effectual in eradicating SARS-CoV-2 from the
nasopharynx. Currently the evidence is quite inconclusive about the effectiveness or
comparative effectiveness of either HCQ or CQ. Moreover, CQ has recently become scarce and
even unavailable for ordering due to a huge demand for it, all because of a significant
interest gained as a potential medicinal alternative for the management of COVID-19. In spite
of all, the primary experience in China and France is propitious for the potential role of
chloroquine, or alternatively hydroxychloroquine, for managing COVID-19.
The reported clinical benefits of the combination of hydroxychloroquine and azithromycin for
patients with COVID-19 come either from media reports or nonrandomized trials with small
numbers of participants (<100 patients). The documented benefit of hydroxychloroquine with or
without azithromycin is very limited, especially in severe disease. While these medications,
individually or in combination, may prove efficacious, these benefits need to be established
with randomized clinical trials prior to widespread adoption of these treatments.
The present study is a randomized, double-blind, controlled, clinical trial, with the
approval of the ethics committee will be conducted on patients who have a positive test
confirming COVID-19 in Shahid Modarres Medical Education Center and Hospital in Tehran.
Patients will be randomly assigned to the two arms of the study and after completing the
course of treatment and collecting and analyzing the necessary information from each patient,
the results of the study will be published both on this site and in the form of an article in
a reputable international journal.
Drug: Hydroxychloroquine
This Drug will be used in all arms as mandated by our governmental guidelines.
Drug: Azithromycin
This will be drug only used in the intervention arm of our study, designed mainly to assess the additional efficacy and safety of Azithromycin in COVID-19 patients.
Inclusion Criteria:
- Age ≥ 18
- COVID-19 Confirmed Cases (Either RT-PCR or CT Scan Confirmed).
- Tympanic Temperature of ≥37.5 AND at least one of the following: Cough, Sputum
production, nasal discharge, myalgia, headache or fatigue) on admission.
- Time of onset of the symptoms should be acute ( Days ≤ 10).
- SpO2 ≤ 93%
- Respiratory Rate ≥ 22
Exclusion Criteria:
- Refusal to participate expressed by patient or legally authorized representative if
they are present.
- Patients with prolonged QT or PR intervals, Second or Third Degree heart block and
Arrhythmias.
- Patients using drugs with potential interaction with Azithromycin or
Hydroxychloroquine.
- Pregnant or lactating women.
- History of alcohol or drug addiction in the past 5 years.
- Blood ALT/AST levels > 5 times the upper limit of normal on laboratory results.
Shahid Modarres Hospital, Shahid Beheshti University of Medical Sciences and Health Services
Tehran, Iran, Islamic Republic of
Seyed Sina Naghibi Irvani, MD, MPH, MBA
09141182825
sina.irvani@gmail.com