A Phase 2 interventional study of Hydroxychloroquine and Lopinavir / Ritonavir in COVID-19, sponsored by Shahid Beheshti University of Medical Sciences. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-05.
Sponsored by Shahid Beheshti University of Medical Sciences · Phase 2, Interventional, and Treatment
The present study is a randomized clinical trial, with the approval of the ethics committee will be conducted on patients who have a positive test confirming COVID-19 in Loghman Hakim Medical Education Center in Tehran. Patients will be randomly assigned to the three 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.
According to previous studies, IFN-β has strong antiviral activity and also has an acceptable safety profile. Based on possible therapeutic effects, We decided to lead An Investigation into Beneficial Effects of Interferon Beta 1a, Compared to Interferon Beta 1b And The Base Therapeutic Regiment in Moderate to Severe COVID-19. In a 2003 study, SARS was treated with different human interferons and found that IFN-β was 5 to 10 times more effective than other types of interferons and the strongest antiviral drug possible against SARS-CoV.
The present study is a randomized clinical trial, with the approval of the ethics committee will be conducted on patients who have a positive test confirming COVID-19 in Loghman Hakim Medical Education Center in Tehran.
Patients will be allocated to three therapeutic arms (Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-β 1a group and Hydroxychloroquine + Lopinavir / Ritonavir + Interferon-β 1b group and the Base Therapeutic Regiment Group, i.e., Hydropinchloroquine + / Ritonavir. For this purpose, we will use the method of Balance Block Randomization for three groups.
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 60 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Shahid Beheshti University of Medical Sciences is the lead sponsor of 221 studies on the registry; 19 are open to participants now.
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Exclusion Criteria:
Drug: Hydroxychloroquine · Drug: Lopinavir / Ritonavir · Drug: Interferon Beta-1A
Drug: Hydroxychloroquine · Drug: Lopinavir / Ritonavir · Drug: Interferon Beta-1B
Drug: Hydroxychloroquine · Drug: Lopinavir / Ritonavir
This Drug will be used in all arms.
This Drug will be used in all arms.
This drug will be only used in Arm 1.
This drug will be only used in Arm 2.
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.
Time frame: From date of randomization until 14 days later.
Mortality
If the patient dies, we have reached an outcome.
Time frame: From date of randomization until 14 days later.
SpO2 Improvement
Pulse-oxymetry
Time frame: Days 1, 2, 3, 4, 5, 6, 7 and 14.
Incidence of new mechanical ventilation use
Incidence of new mechanical ventilation use
Time frame: From date of randomization until 14 days later.
Duration of hospitalization
Duration of hospitalization (days)
Time frame: 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.
Plan to share: Yes — One year after the publication of the results in a journal, Qualifying researchers who reach out to Dr. Seyed Sina Naghibi Irvani at "sina.irvani@sbmu.ac.ir" or "sina.irvani@gmail.com" and submit a proposal with a valuable research question can have access to data and supporting information.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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Shahid Beheshti University of Medical Sciences