Efficacy of Pentoxifylline as Add on Therapy in COVID19 Patients

COVID Clinical Trial

Official title:

Efficacy of Pentoxifylline as Add on Therapy in COVID19 Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04433988
• Other study ID #: RC-6-2020
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: November 13, 2022
• Est. completion date: December 30, 2022

Study information

• Verified date: January 2023
• Source: Sadat City University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID

Intervention

Drug:
• Pentoxifylline
Pentoxifylline 400 mg SR tablet
• Placebo
Placebo tablet

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Shibin Al Kawm

Sponsors (1)

Lead Sponsor	Collaborator
Sadat City University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Outcome	Number of Participants need hospitalization	7 days
Secondary	Respiratory infection	Incidence of any acute respiratory infection	7 days
Secondary	Serious Adverse Events	Absolute and relative frequencies of Serious Adverse Events	7 days