Effect of Pentoxifylline on Prognosis of Coronavirus Disease 2019 (COVID- 19) Infection

NCT04739345 | Completed DMC

• 1 other identifier: COVID-Pentoxifylline
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

Coronavirus disease 2019 (COVID-19) remains a threatening pandemic, due to its rapid transmission, uncertain risk factors for progression that lead to its lethality and yet unsatisfactory antiviral therapy or prophylaxis. The respiratory system remains the most frequently affected by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2), with patients either presenting mild illness as well as more severe complications such as acute respiratory distress syndrome (ARDS) that necessitates admission in Intensive Care Units (ICU). Unfortunately, the remaining patients progress to a second phase-called the inflammatory stage-featuring ARDS, thromboembolic events, and myocardial acute injury. These clinical exacerbation latter predicts poor prognosis associated with an exacerbation of the immune system cascade; a phenomenon known as "cytokine storm". In the context of COVID-19, the hyper inflammation diagnostic criteria are partly defined. Early studies of patients with COVID-19 established independent associations between biomarkers of inflammation, such as C-reactive protein, interleukin \[IL\]-6, ferritin and D-dimer, and severe disease states that require respiratory support or result in death. The aim of this study was to identify practical blood immune- inflammatory biomarker / ratio that could be used alternatively to IL-6 for predicting severity of coronavirus disease 2019 (COVID- 19) in clinical practice. Another aim is to unveil the association of the pro-inflammatory profile as categorized by the IL-6 levels in patients infected by SARS-COV-2, with disease severity and outcomes of COVID -19.

Conditions

Covid19; Corona Virus Infection; Cytokine Storm

Keywords

COVID-19; Cytokine Storm; Interleukin-6

Outcome Measures

Primary Outcomes (4)

• Change in patients' clinical status

  Change in clinical status will be assessed daily using six category ordinal scale. The categories were defined as follows: 1) patient discharged, 2) hospitalization not requiring supplemental oxygen, 3) hospitalization requiring supplemental low-flow oxygen, 4) hospitalization requiring high-flow supplemental oxygen, 5) hospitalization requiring invasive mechanical ventilation, 6) death.

  Two weeks

• Time to increase in oxygenation

  Time to increase in SpO2/FiO2 of 50 or greater compared to the baseline SpO2/FiO2

  48 hours

• Duration of hospitalization

  Length of hospital stay

  Two weeks

• In hospital mortality

  Death occurrence during hospitalization

  Two weeks

Secondary Outcomes (5)

• Incidence of non-invasive mechanical ventilation

  Two weeks

• Duration of non-invasive mechanical ventilation

  Two weeks

• Incidence of invasive mechanical ventilation

  Two weeks

• Duration of invasive mechanical ventilation

  Two weeks

• Occurrence of secondary infection

  Two weeks

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Non-severe patients should meet all following conditions: (1) Epidemiology history, (2) Fever or other respiratory symptoms, (3) Typical CT image abnormities of viral pneumonia, and (4) Positive result of RT-PCR for SARS-CoV-2 RNA.

Drug: Pentoxifylline

Group 2

PLACEBO COMPARATOR

Severe patients should meet at least one of the following conditions: (1) Shortness of breath, RR ≥ 30 times/min, (2) Oxygen saturation (Resting state) ≤ 93%, (3) PaO2/FiO2 ≤ 300 mmHg.

Drug: Pentoxifylline

Interventions

Pentoxifylline DRUG

400 mg of pentoxifylline orally TID with the standard COVID-19 protocol of the Egyptian Ministry of Health

Group 1; Group 2

Eligibility Criteria

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

You may qualify if:

• Age 18 to 65 years.
• COVID-19 hospitalized patients with pneumonia proved by chest X-ray or CT scan.
• Confirmed infection with COVID-19 virus using RT-PCR or strongly suspected to be infected with pending confirmation studies.
• Have acute respiratory distress syndrome (ARDS).
• Having either peripheral capillary oxygen saturation (SpO2) ≤ 94% ambient air, or a partial oxygen pressure (PaO2) to fraction of inspired oxygen (FiO2) ratio ≤ 300 mmHg.

You may not qualify if:

• Age greater than 85 years-old
• Creatinine clearance (CrCl) \< 10ml/min.
• Severe circulatory shock with a dose of norepinephrine higher than 1.0 μg/kg/min.
• Pregnant women.

Sponsors & Collaborators

• Ain Shams University: lead
• Misr International University: collaborator

Study Sites (1)

Teachers Hospital

Cairo, Please Select, 11314, Egypt

Location

MeSH Terms

Conditions

COVID-19; Coronavirus Infections; Cytokine Release Syndrome

Interventions

Pentoxifylline

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; 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)

Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Neven Sarhan, PhD

  Misr International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer at Faculty of Pharmacy

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: February 4, 2021
• Study Start: December 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: October 1, 2022
• Last Updated: February 9, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)