Efficacy of Pentoxifylline as Add on Therapy in COVID19 Patients

With potential antiviral effects on severe acute respiratory syndrome (SARS) and as a methyl-xanthine derived inhibitor of phosphodiesterase-4, pentoxifylline basically functions as a hemorrheologic agent for a better circulation and oxygenation and exerts unique effects on immune modulation, inflammation and oxidative stress. As the main regulator of cAMP metabolism, posphodiesterase-4 plays a key role in proinflammatory and immune cells. Pentoxifylline plays its anti-inflammatory role by reducing the production of proinflammatory cytokines such as TNF-a, IL-1 and IL-6. Given its unique impacts on immune modulation, homeostasis and fibrinolysis and its supportive effects on oxidative stress and organ failure, pentoxifylline can constitute a multipurpose and generally-safe adjuvant therapy for COVID-19 patients.

Study Overview

• Status: Withdrawn
• Conditions: COVID
• Intervention / Treatment: Drug: Placebo; Drug: Pentoxifylline

• Study Type: Interventional
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Mahmoud S Abdallah, PhD; Phone Number: 00201063340887; Email: Mahmoud.samy@fop.usc.edu.eg

Study Locations

• Egypt
  • Shibīn Al Kawm, Egypt
    • Faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Positive COVID-19 test
• Age >/= 18 y.o.

Exclusion Criteria:

• Allergic reaction to Pentoxifylline
• Ongoing anticoagulation
• History of GI bleeding
• History of Seizures
• Cardiac or other vascular stents
• History of severe renal disease
• History of intracranial hemorrhage.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control group; 100 patients will receive standard treatment plus placebo	Drug: Placebo; Placebo tablet
Experimental: Pentoxifylline group; 100 patients will receive standard treatment plus pentoxifylline 1200 mg/day	Drug: Pentoxifylline; Pentoxifylline 400 mg SR tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Outcome	Number of Participants need hospitalization	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Respiratory infection	Incidence of any acute respiratory infection	7 days
Serious Adverse Events	Absolute and relative frequencies of Serious Adverse Events	7 days

Collaborators and Investigators

• Sponsor: Sadat City University

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2022
• Primary Completion (Actual): December 30, 2022
• Study Completion (Actual): December 30, 2022

Study Registration Dates

• First Submitted: June 13, 2020
• First Submitted That Met QC Criteria: June 13, 2020
• First Posted (Actual): June 16, 2020

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: January 16, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Enzyme Inhibitors; Platelet Aggregation Inhibitors; Protective Agents; Antioxidants; Phosphodiesterase Inhibitors; Free Radical Scavengers; Radiation-Protective Agents; Pentoxifylline
• Other Study ID Numbers: RC-6-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No