Covid19
Conditions
Keywords
COVID-19, Interferons, Ritonavir, Lopinavir, Interferon-beta, Antiviral Agents, Anti-Infective Agents, Immunologic Factors
Brief summary
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.
Detailed description
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.
Interventions
DRUGHigh dose Interferon-beta 1a
High dose IFN-β1a (Recigen) (Subcutaneous injections of 88μg (24,000 IU) on days 1, 3, 6)
DRUGLopinavir/Ritonavir
Lopinavir/Ritonavir (Kaletra) \[IFN-β1a group\] (400mg/100 mg twice a day for 10 days
DRUGLow dose Interferon-beta 1a
Low doseIFN-β1a (Recigen) (Subcutaneous injections of 44μg (12,000 IU) on days 1, 3, 6)
Sponsors
Shahid Beheshti University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
* Age ≥ 18 * COVID-19 Confirmed Cases (Either RT-PCR or CT Scan Confirmed) * at least one of the following: radiation contactless body temperature ≥37.5, cough, shortness of breath, nasal congestion/ discharge, myalgia/arthralgia, diarrhea/vomiting, headache or fatigue on admission. * Time of onset of the symptoms should be acute (Days ≤ 14) * NEWS2 ≥ 1 on admission (National Early Warning Score 2)
Exclusion criteria
* Refusal to participate expressed by patient or legally authorized representative if they are present * Patients using drugs with potential interaction with Lopinavir/Ritonavir or Interferon-β 1a * 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. * The patients who were intubated less than one hours after admission to the hospital
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to clinical improvement | From date of randomization until 14 days later | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | From date of randomization until 14 days later | If the patient dies, we have reached an outcome |
| SpO2 Improvement | Days 1, 2, 3, 4, 5, 6, 7 and 14 | Pulse-oxymetry |
| Incidence of new mechanical ventilation use | From date of randomization until 14 days later | — |
| Duration of hospitalization | 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 | Days 1, 2, 3, 4, 5, 6, 7 and 14 | With the incidence of any serious adverse effects, the outcome has happened |
Contacts
Primary ContactIlad Alavi Darazam, MD
Outcome results
None listed