Efficacy of Pentoxifylline as Add on Therapy in COVID19 P... | NCT04433988

Studies
Efficacy of Pentoxifylline as Add on Therapy in COVID19 Patients

NCT04433988

Sponsor

Sadat City University

Status

Withdrawn

Last Update Posted

Jan 18, 2023Actual

Enrollment

0Actual

Phase

Phase 1Phase 2

Conditions

COVID

Interventions

Pentoxifylline
Placebo

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Institutional problems

Expanded Access Info

Start Date

Nov 13, 2022Actual

Primary Completion Date

Dec 30, 2022Actual

Completion Date

Dec 30, 2022Actual

First Submitted Date

Jun 13, 2020

First Submission Date that Met QC Criteria

Jun 13, 2020

First Posted Date

Jun 16, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 16, 2023

Last Update Posted Date

Jan 18, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mahmoud Samy Abdallah, Lecturer of Clinical Pharmacy, PhD., Sadat City UniversityPrincipal Investigator

Lead Sponsor

Sadat City UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control group	Placebo Comparator	100 patients will receive standard treatment plus placebo	Drug: Placebo
Pentoxifylline group	Experimental	100 patients will receive standard treatment plus pentoxifylline 1200 mg/day	Drug: Pentoxifylline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pentoxifylline	Drug	Pentoxifylline 400 mg SR tablet	Pentoxifylline group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine		Shibīn al Kawm			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010431	Pentoxifylline

Ancestor Terms

ID	Term
D013805	Theobromine
D014970	Xanthines
D011688	Purinones
D011687	Purines
D006574

Browse Leaves

Not provided

Browse Branches

Not provided