NCT04521400

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2 covid19

Timeline
Completed

Started Aug 2020

Shorter than P25 for phase_2 covid19

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 20, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

August 20, 2020

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 4, 2020

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 11, 2020

Completed
Last Updated

August 20, 2020

Status Verified

August 1, 2020

Enrollment Period

15 days

First QC Date

August 18, 2020

Last Update Submit

August 19, 2020

Conditions

Covid19

Keywords

COVID-19InterferonsRitonavirLopinavirInterferon-betaAntiviral AgentsAnti-Infective AgentsImmunologic Factors

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Mortality

    From date of randomization until 14 days later

  • SpO2 Improvement

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

  • 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

Study Arms (2)

Arm1

EXPERIMENTAL

Lopinavir /Ritonavir +high dose Interferon-β 1a

Drug: High dose Interferon-beta 1aDrug: Lopinavir/Ritonavir

Arm2

EXPERIMENTAL

Lopinavir /Ritonavir + Low dose Interferon-β 1a

Drug: Lopinavir/RitonavirDrug: Low dose Interferon-beta 1a

Interventions

High dose Interferon-beta 1aDRUG

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

Arm1
Lopinavir/RitonavirDRUG

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

Arm1Arm2
Low dose Interferon-beta 1aDRUG

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

Arm2

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • 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.

    PMID: 32132184BACKGROUND

  • 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.

    PMID: 32221306BACKGROUND

  • 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. No abstract available.

    PMID: 32203186BACKGROUND

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

    PMID: 31771760BACKGROUND

  • 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.

    PMID: 32401715BACKGROUND

  • 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. doi: 10.3201/eid1002.030482.

    PMID: 15030704BACKGROUND

  • 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.

    PMID: 32544867BACKGROUND

  • Alavi Darazam I, Hatami F, Mahdi Rabiei M, Amin Pourhoseingholi M, Shabani M, Shokouhi S, Mardani M, Moradi O, Javandoust Gharehbagh F, Mirtalaee N, Negahban H, Amirdosara M, Zangi M, Hajiesmaeili M, Kazempour M, Shafigh N. An investigation into the beneficial effects of high-dose interferon beta 1-a, compared to low-dose interferon beta 1-a in severe COVID-19: The COVIFERON II randomized controlled trial. Int Immunopharmacol. 2021 Oct;99:107916. doi: 10.1016/j.intimp.2021.107916. Epub 2021 Jun 29.

    PMID: 34224994DERIVED

  • Alavi Darazam I, Hatami F, Rabiei MM, Pourhoseingholi MA, Moradi O, Shokouhi S, Hajesmaeili MR, Shabani M, Irvani SSN. An investigation into the beneficial effects of high-dose interferon beta 1-a, compared to low-dose interferon beta 1-a (the base therapeutic regimen) in moderate to severe COVID-19: A structured summary of a study protocol for a randomized controlled l trial. Trials. 2020 Oct 26;21(1):880. doi: 10.1186/s13063-020-04812-2.

    PMID: 33106183DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Interferon beta-1aLopinavir

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Interferon-betaInterferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Ilad Alavi Darazam, M.D

    Shahid Beheshti University of Medical Sciences

    STUDY CHAIR

  • Firouze Hatami, M.D

    Shahid Beheshti University of Medical Sciences

    PRINCIPAL INVESTIGATOR

  • Mohammad Mahdi Rabiei, M.D

    Shahid Beheshti University of Medical Sciences

    PRINCIPAL INVESTIGATOR

  • Omid Moradi

    Shahid Beheshti University of Medical Sciences

    PRINCIPAL INVESTIGATOR

  • Behnam Rahimi, M.D

    Shahid Beheshti University of Medical Sciences

    PRINCIPAL INVESTIGATOR

  • Shervin Shokouhi, M.D

    Shahid Beheshti University of Medical Sciences

    STUDY DIRECTOR

  • Mohammad Reza Hajesmaeili, M.D

    Shahid Beheshti University of Medical Sciences

    PRINCIPAL INVESTIGATOR

  • Minoosh Shabani, M.D

    Shahid Beheshti University of Medical Sciences

    PRINCIPAL INVESTIGATOR

  • Seyed Sina Naghibi Irvani, M.D

    Shahid Beheshti University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ilad Alavi Darazam, MD

CONTACT

+98-914-149-1958ilad13@yahoo.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Ilad Alavi Darazam, MD

Study Record Dates

First Submitted

August 18, 2020

First Posted

August 20, 2020

Study Start

August 20, 2020

Primary Completion

September 4, 2020

Study Completion

September 11, 2020

Last Updated

August 20, 2020

Record last verified: 2020-08