Efficacy of Pentoxifylline as Add on Therapy in COVID19 Patients

Sponsor

Sadat City University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04433988

Collaborator

(none)

200

Enrollment

Location

Arms

1.5

Anticipated Duration (Months)

129.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID	Drug: Pentoxifylline Drug: Placebo	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

Efficacy of Pentoxifylline as Add on Therapy in COVID19 Patients

Anticipated Study Start Date :

Nov 13, 2022

Anticipated Primary Completion Date :

Dec 30, 2022

Anticipated Study Completion Date :

Dec 30, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Primary Outcome [7 days]
Number of Participants need hospitalization

Secondary Outcome Measures

Respiratory infection [7 days]
Incidence of any acute respiratory infection
Serious Adverse Events [7 days]
Absolute and relative frequencies of Serious Adverse Events

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine	Shibīn Al Kawm		Egypt

Sponsors and Collaborators

Sadat City University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

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

ClinicalTrials.gov Identifier:

NCT04433988

Other Study ID Numbers:

RC-6-2020

First Posted:

Jun 16, 2020

Last Update Posted:

Jan 20, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pentoxifylline

Study Results

No Results Posted as of Jan 20, 2022