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

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04521400
• Other study ID #: Interferon in COVID
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: August 20, 2020
• Est. completion date: September 11, 2020

Study information

• Verified date: August 2020
• Source: Shahid Beheshti University of Medical Sciences
• Contact: Ilad Alavi Darazam, MD
• Phone: +98-914-149-1958
• Email: ilad13[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 11, 2020
• Est. primary completion date: September 4, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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-ß 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

Related Conditions & MeSH terms

• Covid19

Intervention

Drug:
• High dose Interferon-beta 1a
High dose IFN-ß1a (Recigen) (Subcutaneous injections of 88µg (24,000 IU) on days 1, 3, 6)
• Lopinavir/Ritonavir
Lopinavir/Ritonavir (Kaletra) [IFN-ß1a group] (400mg/100 mg twice a day for 10 days
• Low dose Interferon-beta 1a
Low doseIFN-ß1a (Recigen) (Subcutaneous injections of 44µg (12,000 IU) on days 1, 3, 6)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shahid Beheshti University of Medical Sciences

References & Publications (7)

Dastan F, Nadji SA, Saffaei A, Marjani M, Moniri A, Jamaati H, Hashemian SM, Baghaei P, Abedini A, Varahram M, Yousefian S, Tabarsi P. Subcutaneous administration of interferon beta-1a for COVID-19: A non-controlled prospective trial. Int Immunopharmacol. 2020 Aug;85:106688. doi: 10.1016/j.intimp.2020.106688. Epub 2020 Jun 7. — View Citation

Hensley LE, Fritz LE, Jahrling PB, Karp CL, Huggins JW, Geisbert TW. Interferon-beta 1a and SARS coronavirus replication. Emerg Infect Dis. 2004 Feb;10(2):317-9. — View Citation

Hung IF, Lung KC, Tso EY, Liu R, Chung TW, Chu MY, Ng YY, Lo J, Chan J, Tam AR, Shum HP, Chan V, Wu AK, Sin KM, Leung WS, Law WL, Lung DC, Sin S, Yeung P, Yip CC, Zhang RR, Fung AY, Yan EY, Leung KH, Ip JD, Chu AW, Chan WM, Ng AC, Lee R, Fung K, Yeung A, Wu TC, Chan JW, Yan WW, Chan WM, Chan JF, Lie AK, Tsang OT, Cheng VC, Que TL, Lau CS, Chan KH, To KK, Yuen KY. Triple combination of interferon beta-1b, lopinavir-ritonavir, and ribavirin in the treatment of patients admitted to hospital with COVID-19: an open-label, randomised, phase 2 trial. Lancet. 2020 May 30;395(10238):1695-1704. doi: 10.1016/S0140-6736(20)31042-4. Epub 2020 May 10. — View 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. — View Citation

Wang BX, Fish EN. Global virus outbreaks: Interferons as 1st responders. Semin Immunol. 2019 Jun;43:101300. doi: 10.1016/j.smim.2019.101300. Review. — View Citation

Yan R, Zhang Y, Li Y, Xia L, Guo Y, Zhou Q. Structural basis for the recognition of SARS-CoV-2 by full-length human ACE2. Science. 2020 Mar 27;367(6485):1444-1448. doi: 10.1126/science.abb2762. Epub 2020 Mar 4. — View Citation

Zheng HY, Zhang M, Yang CX, Zhang N, Wang XC, Yang XP, Dong XQ, Zheng YT. Elevated exhaustion levels and reduced functional diversity of T cells in peripheral blood may predict severe progression in COVID-19 patients. Cell Mol Immunol. 2020 May;17(5):541-543. doi: 10.1038/s41423-020-0401-3. Epub 2020 Mar 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From date of randomization until 14 days later
Secondary	Mortality	If the patient dies, we have reached an outcome	From date of randomization until 14 days later
Secondary	SpO2 Improvement	Pulse-oxymetry	Days 1, 2, 3, 4, 5, 6, 7 and 14
Secondary	Incidence of new mechanical ventilation use		From date of randomization until 14 days later
Secondary	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
Secondary	Cumulative incidence of serious adverse events	With the incidence of any serious adverse effects, the outcome has happened	Days 1, 2, 3, 4, 5, 6, 7 and 14