Efficacy of Pentoxifylline as Add on Therapy in COVID19 Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-13

Study Completion Date

2022-12-30

Brief Summary

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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.

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Detailed Description

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Conditions

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COVID

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Control group

100 patients will receive standard treatment plus placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tablet

Pentoxifylline group

100 patients will receive standard treatment plus pentoxifylline 1200 mg/day

Group Type EXPERIMENTAL

Pentoxifylline

Intervention Type DRUG

Pentoxifylline 400 mg SR tablet

Interventions

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Pentoxifylline

Pentoxifylline 400 mg SR tablet

Intervention Type DRUG

Placebo

Placebo tablet

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No