Safety and Efficacy of Maraviroc and/or Favipiravir With Standard Therapy in Severe COVID-19 Adults

NCT04475991 | Terminated Phase 2 DMC

• 1 other identifier: DI/20/407/04/38
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

Phase 2, randomized, open-label study to evaluate the safety and efficacy of maraviroc, favipiravir, and both drugs administered along with currently used therapy in hospitalized patients with pulmonary SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2) infection (COVID-19)

Conditions

COVID-19

Keywords

COVID-19; CCR5; Cytokine storm; Maraviroc; Favipiravir; RdRP inhibitors

Outcome Measures

Primary Outcomes (1)

• Patients free of mechanical ventilation or death

  Percentage of patients free of mechanical ventilation or death

  28 days post start

Secondary Outcomes (5)

• Patients free of mechanical ventilation or death

  5 days post start

• Time of clinical improvement

  15 days post start

• Rate of change in phosphorylated CCR5

  Day 10-1

• Rate of change in peripheral blood levels of proinflammatory cytokines and chemokines

  Day 10-1

• Change in the trafficking and activation pattern of peripheral leukocytes

  Day 10-1

Study Arms (4)

Currently used therapy (CT) only

ACTIVE COMPARATOR

Treatment currently used at Hospital General de México "Dr. Eduardo Liceaga" for non-critical COVID patients: Enoxaparin, dexamethasone, and antibiotics if associated bacteremia is present.

Procedure: Curently used therapy for COVID-19 non-critical patients

Maraviroc+CT

EXPERIMENTAL

Maraviroc AND treatment currently used at Hospital General de México "Dr. Eduardo Liceaga" for non-critical COVID patients.

Drug: Maraviroc + Currently used therapy

Favipiravir+CT

EXPERIMENTAL

Favipiravir AND treatment currently used at Hospital General de México "Dr. Eduardo Liceaga" for non-critical COVID patients.

Drug: Favipiravir + Currently used therapy

Maraviroc+Favipiravir+CT

EXPERIMENTAL

Maraviroc AND Favipiravir AND treatment currently used at Hospital General de México "Dr. Eduardo Liceaga" for non-critical COVID patients

Drug: Maraviroc+Favipiravir+CT

Interventions

Maraviroc + Currently used therapy DRUG

Maraviroc tablets. 300 mg bid, given orally for a 10 day period AND CT (Enoxaparin, dexamethasone, and antibiotics if associated bacteremia is present, as per currently used at Hospital General de México "Dr. Eduardo Liceaga")

Also known as: MVC+CT

Maraviroc+CT

Curently used therapy for COVID-19 non-critical patients PROCEDURE

Enoxaparin, dexamethasone, and antibiotics if associated bacteremia is present, as per currently used at Hospital General de México "Dr. Eduardo Liceaga"

Also known as: CT only

Currently used therapy (CT) only

Favipiravir + Currently used therapy DRUG

Favipiravir tablets 200 mg. given orally for a 7 day period. 1600 mg bid on day 1 and 600 mg tid days 2-7 AND CT (Enoxaparin, dexamethasone, and antibiotics if associated bacteremia is present, as per currently used at Hospital General de México "Dr. Eduardo Liceaga").

Also known as: FPV+CT

Favipiravir+CT

Maraviroc+Favipiravir+CT DRUG

Maraviroc tablets. 300 mg bid, given orally for a 10 day period AND Favipiravir tablets 200 mg. given orally for the first 7 days. 1600 mg bid on day 1 and 600 mg tid days 2-7 AND CT (Enoxaparin, dexamethasone, and antibiotics if associated bacteremia is present, as per currently used at Hospital General de México "Dr. Eduardo Liceaga"")

Also known as: MVC+FPV+CT

Maraviroc+Favipiravir+CT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• With severe non-critical stage of COVID at the time of admission.
• Patients tested positive for SARS-CoV-2 confirmed by PCR (Polymerase Chain Reaction) or quick antigen test
• Within the first 12 days post appearance of symptoms
• With at least one of the following risk factors: Diabetes mellitus (DM), obesity (BMI\>30, hypertension, age \> 65 years.
• Respiratory rate 25-34/min and no signs of respiratory distress.
• With at least two of the following indicators of severity: SpO2 81-90%, PaFi 150-300 mmHg, FiO2\>60% , lung damage in thorax radiographic image =\> 25% as determined by RALE score (an equivalent to 2-4).
• Normal liver function (Considered up to a fivefold increase above the normal limits of hepatic transaminases)
• Signed informed consent

You may not qualify if:

• Pregnant or lactating women
• Patients already participating in another clinical study
• Oxygen saturation \< 70% (ambient)
• Clinical evidence of an infectious disease different from COVID at the time of admission
• Chronic kidney failure
• Coronary disease
• Glomerular filtration rate \< 30ml/min/1.73 m2 and known history of preexisting chronic renal failure (Chronic kidney disease stages 4-5)
• Known history of HCV, HBV and/or clinical signs of hepatic liver failure.
• Any type of cancer
• HIV and/or any anti retroviral treatment
• Inability to freely decide to participate
• Psychotropics treatment
• Erythromycin treatment
• Polydrug use (Defined as more than two addictions combined)
• With transplant background

Sponsors & Collaborators

• Hospital General de México Dr. Eduardo Liceaga: lead
• CCINSHAE. Secretaría de Salud. México: collaborator
• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran: collaborator
• Centro de Investigación en. Enfermedades Infecciosas, Mexico: collaborator

Study Sites (1)

Hospital General de México "Dr. Eduardo Liceaga"

Mexico City, Mexico City, 06720, Mexico

Location

MeSH Terms

Conditions

COVID-19; Cytokine Release Syndrome

Interventions

Maraviroc; favipiravir

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• María Luisa Hernández-Medel, MD

  Hospital General de México Dr. Eduardo Liceaga

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Model Details: 100 participants will be included and allocated in 4 groups of 25 each \[Currently used therapy (CT), Maraviroc+CT, Favipiravir+CT and Maraviroc+Favipiravir+CT\]. Subjects will be randomized using EPIDAT 4.2

Study Record Dates

• First Submitted: July 15, 2020
• First Posted: July 17, 2020
• Study Start: July 13, 2021
• Primary Completion: March 15, 2022
• Study Completion: March 25, 2022
• Last Updated: June 3, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Information will be shared upon completion of the study for collaborative purposes
• Access Criteria: Upon request

Locations

ME (1)