the Investigation Into Beneficial Effects of High-dose Interferon Beta 1-a, Compared to Low-dose Interferon Beta 1-a in Moderate to Severe Covid-19

• Status: Not yet recruiting
• Trial end date: 2020-09-11
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Shahid Beheshti University of Medical Sciences
• Treatments: Interferon beta-1a; Interferon-beta; Interferons; Lopinavir; Ritonavir

Criteria

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