Efficacy of Pentoxifylline as Add on Therapy in COVID19 Patients

Phase 1

Withdrawn

• Conditions: COVID
• Interventions: Drug: Placebo; Drug: Pentoxifylline

• Registration Number: NCT04433988
• Lead Sponsor: Sadat City University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-13
• Study First Submitted QC: 2020-06-13
• Study First Posted: 2020-06-16
• Study Start: 2022-11-13
• Primary Completion: 2022-12-30
• Study Completion: 2022-12-30
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-16
• Last Update Posted: 2023-01-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Placebo	100 patients will receive standard treatment plus placebo
Pentoxifylline group	Pentoxifylline	100 patients will receive standard treatment plus pentoxifylline 1200 mg/day

Primary Outcome Measures

Name	Time	Method
Primary Outcome	7 days	Number of Participants need hospitalization

Secondary Outcome Measures

Name	Time	Method
Respiratory infection	7 days	Incidence of any acute respiratory infection
Serious Adverse Events	7 days	Absolute and relative frequencies of Serious Adverse Events

Trial Locations

Locations (1)

Faculty of Medicine; 🇪🇬 Shibīn Al Kawm, Egypt