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Trial record 36 of 243 for:    "Viral Infectious Disease" | "Lopinavir"

MERS-CoV Infection tReated With A Combination of Lopinavir /Ritonavir and Interferon Beta-1b (MIRACLE)

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ClinicalTrials.gov Identifier: NCT02845843
Recruitment Status : Recruiting
First Posted : July 27, 2016
Last Update Posted : March 7, 2019
Sponsor:
Information provided by (Responsible Party):
King Abdullah International Medical Research Center

Brief Summary:
This is a placebo-controlled clinical trial to assess the feasibility, efficacy and safety of a combination of lopinavir/ritonavir and Interferon beta-1b in hospitalized patients with MERS.

Condition or disease Intervention/treatment Phase
Middle East Respiratory Syndrome Coronavirus (MERS-CoV) Drug: Combination of Lopinavir /Ritonavir and Interferon beta-1b Drug: Placebo Phase 2 Phase 3

Detailed Description:
The aim of this study is to investigate the feasibility , efficacy and safety of lopinavir /ritonavir and recombinant Interferon beta-1b combination given with optimal supportive care compared to placebo with optimal supportive care for patients with laboratory-confirmed MERS-CoV infection requiring hospital admission.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 194 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a recursive two-stage group sequential multicenter placebo-controlled double-blind randomized controlled trial. The trial is initially designed to include 2 two-stage components. The first two-stage component is designed to adjust sample size and determine futility stopping, but not efficacy stopping (n=34). The second two-stage component is designed to determine efficacy stopping and possibly readjustment of sample size.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: MERS-CoV Infection tReated With A Combination of Lopinavir /Ritonavir and Interferon Beta-1b: a Multicenter, Placebo-controlled, Double-blind Randomized Trial
Actual Study Start Date : July 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
Experimental: Combination of Lopinavir /Ritonavir and IntErferon Beta 1B
Lopinavir /Ritonavir 400mg +100 mg / ml twice daily for 14 days and Interferon beta-1b 0.25 mg subcutaneous every alternate day for 14 days
Drug: Combination of Lopinavir /Ritonavir and Interferon beta-1b
Lopinavir /Ritonavir 400mg +100 mg / ml twice daily for 14 days and Interferon beta-1b 0.25 mg subcutaneous every alternate day for 14 days

Placebo Comparator: Placebo
Same characteristics as Lopinavir /Ritonavir and Interferon beta-1b to maintain blinding
Drug: Placebo
Same characteristics as Lopinavir /Ritonavir and Interferon beta-1b to maintain blinding




Primary Outcome Measures :
  1. 90-day mortality [ Time Frame: 90-day ]

Secondary Outcome Measures :
  1. Organ support-free days (e.g., supplemental O2, ventilator, extracorporeal membrane oxygenation (ECMO), renal replacement and vasopressors) [ Time Frame: 28 days ]
  2. RT-PCR cycle threshold value in the lower respiratory samples [ Time Frame: At randomization and every 3 days afterwards, until 3 consecutive samples are negative or reaching a maximum of 90 days ]
  3. Sequential organ failure assessment (SOFA) scores [ Time Frame: Days 1, 3, 5, 7, 14, and 28 ]
  4. Length of stay in ICU [ Time Frame: Up to one year from enrollment ]
  5. Length of stay in hospital [ Time Frame: Up to one year from enrollment ]
  6. Duration of mechanical ventilation [ Time Frame: Up to one year from enrollment ]
  7. Hospital-acquired infections as assessed by the NHSN 2016 definitions [ Time Frame: Up to one year from enrollment ]
    Infections will be reported as per the NHSN 2016 definitions, as number of events per devise day or ICU day as appropriate.

  8. Serial chest radiograph findings [ Time Frame: 28 day ]
  9. Number of Patients with Adverse drug reactions related to the treatment [ Time Frame: From enrollment to 28 day ]
  10. Karnofsky Performance Scale [ Time Frame: 90-day ]
  11. ICU mortality [ Time Frame: Up to one year from enrollment ]
  12. Hospital mortality [ Time Frame: Up to one year from enrollment ]
  13. 28-day mortality [ Time Frame: 28-day ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria at eligibility assessment

  1. Adult (defined as ≥18 years of age);
  2. Laboratory confirmation of MERS-CoV infection by reverse-transcription polymerase chain reaction (RT-PCR) from any diagnostic sampling source; and
  3. New organ dysfunction that is judged to related to MERS including: hypoxia defined as requirement of supplemental oxygen to maintain oxygen saturations >90%, hypotension (systolic blood pressure<90 mmHg) or need for vasopressor/inotropic medication, renal impairment (increase of creatinine by 50% from baseline, glomerular filtration rate reduction by >25% from baseline or urine output of <0.5 ml/kg for 6 hours - Risk stage by RIFLE criteria), neurologic (reduction of Glasgow Coma Scale by 2 or more, i.e. 13 or lower of 15 points), thrombocytopenia (<150,000 platelets/mm3) or gastrointestinal symptoms that requires hospitalization (e.g. severe nausea, vomiting, diarrhea or/and abdominal pain).

Exclusion criteria at eligibility assessment

  1. Suicidal ideation based on history (contraindication to interferon (IFN)-β1b);
  2. Known allergy or hypersensitivity reaction to lopinavir/ritonavir or to recombinant IFN-β1b, including, but not limited to, toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, urticaria or angioedema;
  3. Elevated alanine aminotransferase (ALT) >5 fold the upper limit in the hospital's laboratory;
  4. Use of medications that are contraindicated with lopinavir/ritonavir and that cannot be replaced or stopped during the study period, such as CYP3A inhibitors;
  5. Pregnancy - eligible and consenting female participants in childbearing age will be tested for pregnancy before enrollment in the study;
  6. Known HIV infection, because of concerns about the development of resistance to lopinavir/ritonavir if used without combination with other anti-HIV drugs; or
  7. Patient likely to be transferred to a non-participating hospital within 72 hours.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02845843


Contacts
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Contact: Yaseen Arabi, MD +966-11-8011111 ext 18855 yaseenarabi@yahoo.com

Locations
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Saudi Arabia
Intensive Care Unit, King Abdulaziz Medical City, National Guard Health Affairs Recruiting
Riyadh, Saudi Arabia, 11426
Contact: Yaseen M Arabi, MD    +966(11)8011111 ext 18855    yaseenarabi@yahoo.com   
Principal Investigator: Yaseen M Arabi, MD         
King Abdullah International Medical Research Center Not yet recruiting
Riyadh, Saudi Arabia, 22490
Contact: Yaseen Arabi, MD, FCCP, FCCM    966-11-8011111 ext 18899    arabi@ngha.med.sa   
Sponsors and Collaborators
King Abdullah International Medical Research Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: King Abdullah International Medical Research Center
ClinicalTrials.gov Identifier: NCT02845843     History of Changes
Other Study ID Numbers: KingAbdullahIMRC
First Posted: July 27, 2016    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by King Abdullah International Medical Research Center:
Middle East Respiratory Syndrome Coronavirus
MERS-CoV
Clinical trial
Lopinavir
Ritonavir
Interferon beta
Additional relevant MeSH terms:
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RNA Virus Infections
Virus Diseases
Lopinavir
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
Interferons
Ritonavir
Interferon-beta
Interferon beta-1b
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic