A Phase 2 interventional study of High dose Interferon-beta 1a and Lopinavir/Ritonavir in Covid19, sponsored by Shahid Beheshti University of Medical Sciences. Status unknown. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-20.
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 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.
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 high-dose Interferon Beta 1a, Compared to low-dose Interferon Beta 1a (the base therapeutic regimen) in Moderate to Severe COVID-19.
Previous studies demonstrate that IFN-β 1a could be used against some coronaviruses including avium infectious, bronchitis virus, murine hepatitis virus, and SARS- CoV because they are susceptible in vitro or in vivo. In a current study, the efficacy of IFN-β 1a in COVID-19 patients were evaluated, and they found than IFN-β 1a reduced the disease symptoms.
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 100 is close to 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.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Lopinavir /Ritonavir +high dose Interferon-β 1a
Drug: High dose Interferon-beta 1a · Drug: Lopinavir/Ritonavir
Lopinavir /Ritonavir + Low dose Interferon-β 1a
Drug: Lopinavir/Ritonavir · Drug: Low dose Interferon-beta 1a
High dose IFN-β1a (Recigen) (Subcutaneous injections of 88μg (24,000 IU) on days 1, 3, 6)
Lopinavir/Ritonavir (Kaletra) \[IFN-β1a group\] (400mg/100 mg twice a day for 10 days
Low doseIFN-β1a (Recigen) (Subcutaneous injections of 44μg (12,000 IU) on days 1, 3, 6)
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
Time frame: From date of randomization until 14 days later
Duration of hospitalization
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
Cumulative incidence of serious adverse events
With the incidence of any serious adverse effects, the outcome has happened
Time frame: Days 1, 2, 3, 4, 5, 6, 7 and 14
No study locations are listed for this record.
Plan to share: Undecided
This study is status unknown, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Shahid Beheshti University of Medical Sciences