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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

Primary Purpose

Covid19

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

High dose Interferon-beta 1a

Lopinavir/Ritonavir

Low dose Interferon-beta 1a

About this trial

This is an interventional treatment trial for Covid19 focused on measuring COVID-19, Interferons, Ritonavir, Lopinavir, Interferon-beta, Antiviral Agents, Anti-Infective Agents, Immunologic Factors

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm1

Arm2

Arm Description

Lopinavir /Ritonavir +high dose Interferon-β 1a

Lopinavir /Ritonavir + Low dose Interferon-β 1a

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Mortality

If the patient dies, we have reached an outcome

SpO2 Improvement

Pulse-oxymetry

Incidence of new mechanical ventilation use

Duration of hospitalization

Cumulative incidence of serious adverse events

With the incidence of any serious adverse effects, the outcome has happened

Full Information

NCT ID

NCT04521400

First Posted

August 18, 2020

Last Updated

August 19, 2020

Sponsor

Shahid Beheshti University of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT04521400

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Unknown status

Study Start Date

August 20, 2020 (Anticipated)

Primary Completion Date

September 4, 2020 (Anticipated)

Study Completion Date

September 11, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shahid Beheshti University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid19

Keywords

COVID-19, Interferons, Ritonavir, Lopinavir, Interferon-beta, Antiviral Agents, Anti-Infective Agents, Immunologic Factors

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm1

Arm Type

Experimental

Arm Description

Lopinavir /Ritonavir +high dose Interferon-β 1a

Arm Title

Arm2

Arm Type

Experimental

Arm Description

Lopinavir /Ritonavir + Low dose Interferon-β 1a

Intervention Type

Drug

Intervention Name(s)

High dose Interferon-beta 1a

Intervention Description

High dose IFN-β1a (Recigen) (Subcutaneous injections of 88μg (24,000 IU) on days 1, 3, 6)

Intervention Type

Drug

Intervention Name(s)

Lopinavir/Ritonavir

Intervention Description

Lopinavir/Ritonavir (Kaletra) [IFN-β1a group] (400mg/100 mg twice a day for 10 days

Intervention Type

Drug

Intervention Name(s)

Low dose Interferon-beta 1a

Intervention Description

Low doseIFN-β1a (Recigen) (Subcutaneous injections of 44μg (12,000 IU) on days 1, 3, 6)

Primary Outcome Measure Information:

Title

Time to clinical improvement

Description

Time Frame

From date of randomization until 14 days later

Secondary Outcome Measure Information:

Title

Mortality

Description

If the patient dies, we have reached an outcome

Time Frame

From date of randomization until 14 days later

Title

SpO2 Improvement

Description

Pulse-oxymetry

Time Frame

Days 1, 2, 3, 4, 5, 6, 7 and 14

Title

Incidence of new mechanical ventilation use

Time Frame

From date of randomization until 14 days later

Title

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

Title

Cumulative incidence of serious adverse events

Description

With the incidence of any serious adverse effects, the outcome has happened

Time Frame

Days 1, 2, 3, 4, 5, 6, 7 and 14

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ilad Alavi Darazam, MD

Phone

+98-914-149-1958

ilad13@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ilad Alavi Darazam, M.D

Organizational Affiliation

Shahid Beheshti University of Medical Sciences

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Firouze Hatami, M.D

Organizational Affiliation

Shahid Beheshti University of Medical Sciences

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Mohammad Mahdi Rabiei, M.D

Organizational Affiliation

Shahid Beheshti University of Medical Sciences

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Omid Moradi

Organizational Affiliation

Shahid Beheshti University of Medical Sciences

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Behnam Rahimi, M.D

Organizational Affiliation

Shahid Beheshti University of Medical Sciences

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Shervin Shokouhi, M.D

Organizational Affiliation

Shahid Beheshti University of Medical Sciences

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Mohammad Reza Hajesmaeili, M.D

Organizational Affiliation

Shahid Beheshti University of Medical Sciences

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Minoosh Shabani, M.D

Organizational Affiliation

Shahid Beheshti University of Medical Sciences

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Seyed Sina Naghibi Irvani, M.D

Organizational Affiliation

Shahid Beheshti University of Medical Sciences

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

32132184

Citation

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Results Reference

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PubMed Identifier

32221306

Citation

Ou X, Liu Y, Lei X, Li P, Mi D, Ren L, Guo L, Guo R, Chen T, Hu J, Xiang Z, Mu Z, Chen X, Chen J, Hu K, Jin Q, Wang J, Qian Z. Characterization of spike glycoprotein of SARS-CoV-2 on virus entry and its immune cross-reactivity with SARS-CoV. Nat Commun. 2020 Mar 27;11(1):1620. doi: 10.1038/s41467-020-15562-9. Erratum In: Nat Commun. 2021 Apr 1;12(1):2144.

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Citation

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PubMed Identifier

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Citation

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Results Reference

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PubMed Identifier

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Citation

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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

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