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Hydroxychloroquine in comparison with hydroxychloroquine + azithromycin in patients with covid-19

Evaluation of the efficiency of hydroxychloroquine drug regimen in comparison with hydroxychloroquine + azithromycin in hospitalized patients with covid-19 in the intensive care unit

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200428047228N2
Enrollment
40
Registered
2020-06-10
Start date
2020-05-19
Completion date
Unknown
Last updated
2020-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19. U07.1 - COVID-19

Interventions

Intervention 1: Intervention group: hydroxychloroquine, 400 mg BD on the first day and 200 mg hydroxychloroquine BD daily on the second to seventh day and concurrent, Azithromycin at a dose of 500 mg

Sponsors

Quality Improvement of Intensive Care Research Center- Shahid Beheshti University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 100 Years

Inclusion criteria

Inclusion criteria: Diagnosis of COVID-19 based on either ground glass appearance in chest CT scan or positive RT-PCR test for COVID-19 Requiring hospitalization on the basis of level of consciousness,blood pressure, kidney and liver failure Patient's age between 16 and 100 years Signed informed consent form

Exclusion criteria

Exclusion criteria: Chronic liver and kidney failure HIV patients pregnancy and breast feeding QT interval more than 500 milliseconds

Design outcomes

Primary

MeasureTime frame
Length of stay in the intensive care unit. Timepoint: Once (when discharged from intensive care unit). Method of measurement: Hospital records.;In-hopital mortality. Timepoint: once. Method of measurement: Medical records.

Secondary

MeasureTime frame
Length of stay in hospital. Timepoint: Once at discharge. Method of measurement: Patient medical records.;Radiological Treatment Response (CT scan) , more than 50% reduction in the affected area. Timepoint: CT scan will be done twice (once at the time of admission and the second time 10 days after discharge). Assessment will be done comparing the second CT with the first one. Method of measurement: Patient CT scan.;Laboratory Treatment Response; return of blood cell count and CRP values to normal. Timepoint: Daily. Method of measurement: Laboratory kits.;Fever. Timepoint: Daily. Method of measurement: Patient medical records.;Dyspnea. Timepoint: Daily. Method of measurement: Patient medical records.;Oxygen saturation without supplemental oxygen. Measurement will be done after discontinuation of oxygen therapy for 5 minutes. Timepoint: 4 times a day while in the wards. Method of measurement: Observation.;Adverse drug reactions. Timepoint: Daily. Method of measurement: Adverse Drug Reaction forms.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Mohammad Fathi

Shahid Beheshti University of Medical Sciences

m.fathi@sbmu.ac.ir+98 21 2351 5366

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026