Study Stopped
Institutional problems
Efficacy of Pentoxifylline as Add on Therapy in COVID19 Patients
1 other identifier
interventional
N/A
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Nov 2022
Shorter than P25 for phase_1
1 active site
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
June 13, 2020
CompletedFirst Posted
Study publicly available on registry
June 16, 2020
CompletedStudy Start
First participant enrolled
November 13, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2022
CompletedJanuary 18, 2023
January 1, 2023
2 months
June 13, 2020
January 16, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Primary Outcome
Number of Participants need hospitalization
7 days
Secondary Outcomes (2)
Respiratory infection
7 days
Serious Adverse Events
7 days
Study Arms (2)
Control group
PLACEBO COMPARATOR100 patients will receive standard treatment plus placebo
Pentoxifylline group
EXPERIMENTAL100 patients will receive standard treatment plus pentoxifylline 1200 mg/day
Interventions
Eligibility Criteria
You may qualify if:
- Positive COVID-19 test
- Age \>/= 18 y.o.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Medicine
Shibīn al Kawm, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of Clinical Pharmacy, PhD.
Study Record Dates
First Submitted
June 13, 2020
First Posted
June 16, 2020
Study Start
November 13, 2022
Primary Completion
December 30, 2022
Study Completion
December 30, 2022
Last Updated
January 18, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF