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.
Drug: High dose Interferon-beta 1a
High dose IFN-β1a (Recigen) (Subcutaneous injections of 88μg (24,000 IU) on days 1, 3, 6)
Drug: Lopinavir/Ritonavir
Lopinavir/Ritonavir (Kaletra) [IFN-β1a group] (400mg/100 mg twice a day for 10 days
Drug: Low dose Interferon-beta 1a
Low doseIFN-β1a (Recigen) (Subcutaneous injections of 44μg (12,000 IU) on days 1, 3, 6)
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
Ilad Alavi Darazam, MD
+98-914-149-1958
ilad13@yahoo.com