COVID-19 Clinical Trial
— AICOfficial title:
Efficacy and Safety of Azithromycin Compared to the Base Therapeutic Regiment of Hydroxychloroquine in Moderate to Severe COVID-19: A Randomized, Controlled, Double-Blind, Clinical Trial
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.
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | May 5, 2020 |
Est. primary completion date | May 3, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Iran, Islamic Republic of | Shahid Modarres Hospital, Shahid Beheshti University of Medical Sciences and Health Services | Tehran |
Lead Sponsor | Collaborator |
---|---|
Shahid Beheshti University of Medical Sciences |
Iran, Islamic Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to clinical improvement | Improvement of two points on a seven-category ordinal scale (recommended by the World Health Organization: Coronavirus disease (COVID-2019) R&D. Geneva: World Health Organization) or discharge from the hospital, whichever came first. | From date of randomization until 14 days later. | |
Secondary | Mortality | If the patient dies, we have reached an outcome. | From date of randomization until 14 days later. | |
Secondary | SpO2 Improvement | Pulse-oxymetry | Days 1, 2, 3, 4, 5, 6, 7 and 14. | |
Secondary | Incidence of new mechanical ventilation use | Incidence of new mechanical ventilation use (Rate) | From date of randomization until 14 days later. | |
Secondary | Duration of hospitalization | Duration of hospitalization (Days) | From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 14 days. | |
Secondary | Cumulative incidence of serious adverse events | With incidence of any serious adverse effects, the outcome has happened. | Days 1, 2, 3, 4, 5, 6, 7 and 14. |
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